Archive for the ‘Hormone Physician’ Category

From left, Declan, Cian and Rowan pose on the front porch of their Norwood home this week. Declan and Cian, identical twin brothers, and fraternal sister Rowan, were conceived through in vitro fertilization and born as micro preemies. Christopher Lenney/Watertown Daily Times

NORWOOD Expert fertility statistics and probability outcomes would never have accounted for the DeShane triplets.

Born on different days and in different years two splitting an embryo and all surviving natural births three Norwood babies have beaten the odds.

At 22 weeks, 6 days, Cian J. DeShane was born Dec. 28, 2019, at the University of Vermont Medical Centers Neonatal Intensive Care Unit. With tubing in, he spanned 11 inches and weighed 1 pound, 0.9 ounces, about the weight of a loaf of bread.

After being fully-dilated and having contractions for 5 days, Cians umbilical cord cut, Kaylie E. (Mousaw) DeShane gave birth to Cians identical twin brother Declan B. and their sister Rowan M. on Jan. 2, 2020. Declan weighed 1 pound, 7.6 ounces, and Rowan came in at 1 pound, 1 ounce.

All six eyelids were fused shut at birth, but outside their Norwood home during a brief visit this week, the DeShane triplets looked out at the world, at bicyclists passing on Main Street, with bright excitement.

Nurses at the University of Vermont Medical Center NICU awarded the DeShane triplets each a Grammy for achieving weight milestones. Christopher Lenney/Watertown Daily Times

If they had been carried to full-term, Cian, Declan and Rowan would be about 4 months old. Now nearly 8 months old, the trio is meeting all adjusted milestones expected of 4-month-olds.

But the wide-eyed, growing and curious babies were once barely bigger than an adults palm. At 15 days old, Rowans entire hand was the size of her dads index fingernail. Cian and Rowan developed an intestinal disease; Cian fought pneumonia; and all three struggled with respiratory issues, particularly in their first days and weeks of life.

During the uncertain four months the triplets spent in the NICU, Kaylie said, dozens of family, friends and strangers prayed for the miracle babies, the uterine warriors, as one UVMC specialist put it.

As the weeks rolled into months at the NICU, Kaylie and her husband Brandon J. DeShane initially stayed at the Burlington Ronald McDonald House in shifts until the COVID-19 pandemic shut down the country mid-March and Ronald McDonald families were kicked out.

The hospital, Kaylie said, covered hotel rates during the remainder of the triplets NICU stay, which totaled about $1 million in medical costs for each member of the trio, the early births qualifying the DeShanes for Medicaid.

Kaylie E. DeShane holds her son Cian for the first time Jan. 16, at the University of Vermont Medical Center NICU. Cian was born at 22 weeks, 6 days, on Dec. 28, 2019. His identical twin brother Declan and fraternal sister Rowan were born Jan. 2, 2020. Provided photo

With two children at home in the north country, 11-year-old Naveah and 6-year-old Holden, Kaylie and Brandon took turns making the 120-mile trip between Norwood and Burlington, and the babies continued vanquishing every life-threatening emergency.

The theory of their persistence, their fight, Kaylie said, became centered on the bumblebee, and a phrase popularized by the introduction to the 2007 animated Bee Movie.

According to all known laws of aviation, there is no way a bee should be able to fly, the screenplay reads. Its wings are too small to get its fat little body off the ground. The bee, of course, flies anyway because bees dont care what humans think is impossible.

Though a misconception that bees or other insects break fundamental laws of physics through flight, the idea of the impossibility originated from French entomologist and engineer Antoine Magnan. In the 1930s, he famously compared bumblebee flight to the aeronautics of powered flight to doing the unthinkable.

That concept became the lifeblood of the DeShane triplets, who didnt know they shouldnt be able to fly.

And they didnt care, Kaylie said, adding that the seeming attitude of Cian, Declan and Rowan inspired rallying hope spanning two states, and reaching an online community of thousands of mothers of micro preemies. If they believe they can make it, then we should believe them, too.

Brandon J. DeShane holds Cian, left, and Rowan, on the front porch of their Norwood home this week. Cian was born at 22 weeks, 6 days on Dec. 28, 2019. Rowan, along with Cians identical twin Declan, was born almost six days later on Jan. 2, 2020. Christopher Lenney/Watertown Daily Times

What are the odds?

Kaylie, originally from Potsdam, is a senior chemical dependency counselor for St. Lawrence County. She and Brandon, a Norwood native and current stay-at-home dad, married in 2015. Naveah is Kaylies stepdaughter, and the couple officially adopted Holden in 2017. When Kaylie and Brandon decided to begin the process of having biological children about four years ago, they worked with Northeastern Reproductive Medicine, a fertility clinic in Colchester, Vt., to address infertility issues and Kaylies Polycystic Ovary Syndrome, or PCOS.

PCOS, according to the Mayo Clinic, is a hormonal disorder causing excess production of male hormone levels, infrequent or prolonged menstruation and increased potential for the ovaries to develop fluid pockets and fail to regularly release eggs. The Centers for Disease Control and Prevention reports PCOS as one of the most common causes of womens infertility, affecting as many as 5 million women of reproductive age in the United States.

Through in vitro fertilization, the manual combination of an extracted egg and a sperm sample in a laboratory setting, two of Kaylies fertilized eggs were transferred to her uterus last year. Months and sometimes years before a transfer can be conducted, fertility medications are prescribed to stimulate egg production and adjust hormone levels. Once implanted in the wall of the uterus, one of Kaylies embryos split, leading to identical twins Cian and Declan.

Kaylie E. DeShane holds her son Declan for the first time Jan. 13, at the University of Vermont Medical Center NICU. Provided photo

To avoid a multiple pregnancy and its risks, including miscarriage, premature delivery and low birthweight, most fertility clinics prefer to transfer a single embryo to a womans uterus. Given Kaylies infertility, she said, Northeastern agreed to transfer two.

Figures of chance for twin and triplet births vary by reporting agency and method of conception, and depend on a familys fertility history and differing data collection across clinics.

But generally, the chance of carrying identical twins to term is rare for any conception method. The chance of one embryo splitting and a second successfully implanting through IVF, resulting in identical twins and one fraternal sibling, is rarer still.

Based on years of published research before it, a 2016 Columbia University study of 27 IVF providers and 10 patients indicates twins born to mothers through IVF are 12 times more likely than single babies to be born prematurely, 16 times more likely to have low birthweights and five times more likely to be born with respiratory complications.

Due April 26, 2020, the DeShane triplets fulfilled all three of those projections.

Neonatologist Deirdre OReilly, UVMC director of the Neonatal Medical and Developmental Follow-up Clinic, will see Cian, Declan and Rowan for at least the next two years. The DeShanes continue to make regular visits to their local physician, as well as UVMC specialists, including a pediatric pulmonologist for lung health and an ophthalmologist for vision.

Kaylie E. DeShane displays a preemie diaper, one too big for her triplets when they where born weighing about 1 pound each. Christopher Lenney/Watertown Daily Times

Last month, Dr. OReilly told UVMC Childrens Hospital she had never, in her 13 years of practice, seen a baby born as early as Cian survive.

Full-term babies are carried for 39 weeks, and the World Health Organization sets the pre-term threshold at 37 weeks, with those born between 28 and 32 weeks categorized as very pre-term. Babies born alive after less than 28 weeks are considered extremely pre-term. The United States, according to the most recent WHO data, ranks sixth among countries with the greatest number of pre-term births each year, 517,400 in 2017.

For micro preemies birthed at 22 to 23 weeks, extended infant survivability is low, and some hospitals may choose not to attempt intense medical interventions or treat life-threatening conditions, depending on whether policies are in place.

The American Academy of Pediatrics and the American Congress of Obstetricians and Gynecologists both recommend families develop their own plans with clinicians, should decisions need to be made about treating extremely pre-term babies.

The DeShanes told their delivery room team they wanted anything and everything to be done for the triplets.

The New England Journal of Medicine in 2015 published data about more than 4,000 premature babies born between 2006 and 2011, all before 27 weeks of gestation. The overall rate of survival for those born at 22 weeks who did not receive active treatment was 5.1 percent. The survival rate for 22-weekers who received active treatment defined in the study as any potentially lifesaving intervention administered after birth was calculated to be 23.1 percent.

Over the last decade, support for such interventions at 22 weeks has grown, among clinicians and families with children who survived birth between 22 and 25 weeks.

Nurses at the University of Vermont Medical Center NICU logged every note and decorated photos for each of the DeShane triplets over the four months they spent in the NICU. Christopher Lenney/Watertown Daily Times

Twenty Two Matters

With each update and each minor victory, the DeShanes support network expanded the DeShane and Mousaw families led prayer and cheerleading efforts in the north country, along with mothers from the nonprofit TwentyTwo Foundation. The foundation serves as a sister organization to the online group TwentyTwo Matters, nearly 5,000 advocates and mothers celebrating micro preemies and their milestones.

But in the hours and days after she went into labor, and despite such support, Kaylie said, she felt like giving up.

Kaylie and Brandon had traveled to Burlington for a scheduled anatomy scan Dec. 27, and were staying at a hotel in Plattsburgh when her water broke.

Kaylies cervix had already failed once, meaning her cervix the tissue at the neck of the womb that opens during childbirth was weakening and opening too early. At 16 weeks, the risk of miscarriage or pre-term birth was high, and Kaylie could either miscarry intentionally or undergo a cervical cerclage procedure to close her cervix. Cervical cerclage stitches the cervix closed, but the procedure itself, coupled with Kaylies already high-risk pregnancy, was risky for both mother and babies. Kaylie could have hemorrhaged and a failed cerclage could have prompted an even earlier birth.

I wasnt going to voluntarily kill my babies by doing nothing, she said. So they stitched me up.

By the time fluid drenched the hotel room floor 6 weeks later, Kaylie was preparing for the worst. She said she even texted her family members, asking them not to call and assuming Cian, Declan and Rowan, with names picked out, wouldnt survive. Twenty-two weeks, she thought, was just too early.

At 15 days old, Rowan holds her father Brandon J. DeShanes hand for the first time Jan. 17, at the University of Vermont Medical Center NICU. Rowan was born Jan. 2, with her brother Declan, about five days after the first triplet, Cian, was born. Provided photo

Once at Champlain Valley Physicians Hospital in Plattsburgh that night, the DeShanes were told a transfer to UVMC was not immediately available, that it would be faster for the couple to drive themselves. So Brandon drove Kaylie to the western shore of Lake Champlain, where they ferried across to Vermont. The soon-to-be mother of triplets arrived barefoot in the snow.

The morning of Cians birth, Kaylie had severe pain and bleeding because the eldest triplet had torn through her cervical stitches.

Then it all happened so fast, she said.

Adorned in yellow gowns, four NICU nursing teams were at the ready, one dedicated to each baby and one to Kaylie.

Cian was successfully intubated, initially receiving oxygen 24/7 with the ventilator breathing for him. Then at 23 weeks, 4 days, and in a new year, Kaylie gave birth to Declan and Rowan.

Rowan, who had a severe brain bleed that didnt worsen and eventually resolved itself, later developed necrotizing enterocolitis, or NEC. The CDC lists NEC as a leading cause of infant mortality in the United States, and medical professionals dont fully understand the intestinal disease, though it is clear it primarily affects premature infants and presents with a swollen belly or bloody stool.

Rowan stabilized, but Cians NEC prognosis was less positive, and the DeShanes were asked to write an end-of-life plan for him. Kaylie refused, and Cian overcame.

That would mean wed be giving up, that we believed he wasnt going to make it, she said. And we couldnt believe that.

Cian also developed pneumonia and NEC more than once, most recently recovering in March, and hell eventually have surgery to remove a hernia the first surgery for any of the DeShane babies.

Bumblebee emblems gradually started to appear in the NICU, bees were pinned to nurses badges as teams diligently and quietly cared for the triplets. One word uttered too loud, one step too forceful, and the fragile beings would have suffered.

Five words floated in the air of the unit: Dont give up on them.

Kaylie E. DeShane holds Declan this week in Norwood. Declan was born Jan. 2, 2020, at 23 weeks, 4 days. Christopher Lenney/Watertown Daily Times

Eleven days after his birthday, Declan was approved to be held on Jan. 13. Cian and Rowan followed, on Jan. 16 and 17.

Naveah and Holden spent their February school break at the Ronald McDonald House with their parents, visiting their siblings for the week.

What hell they had to go through, Kaylie said of her two older children, who spent months with only one parent at a time, always prepared for a reality that their baby brothers and sister might not have come home.

Declan, born the largest and having the fewest major issues, celebrated his homecoming April 17, beating his due date by nine days. Rowan left the NICU April 30, and Cian arrived in Norwood May 4. Home aides have assisted with daily monitoring, and the babies now only receive extra oxygen while sleeping at night to foster growth, no longer needing ventilators to survive.

Declan is an active trouble maker, Cian an old man, Kaylie said, because of his noises and groans. Rowan curls into a ball, like a hedgehog, when she doesnt want to be touched.

For the DeShanes, 2019-20 has been a roller coaster year, with a pregnancy announcement, a rare triplet birth, a global pandemic and more than $3 million in medical bills.

You take it one day at a time, Kaylie said. You look back later and you have no idea how you did it.

Original post:
Norwood triplets, born on different days in different years, beat the odds - NNY360

When it comes to experimental cholesterol drugs, all eyes this year are on inclisiran, the $9.7 billion RNAi drug Novartis hopes will replace and vastly outsell Regeneron and Amgens PCSK9 inhibitors.

Yet Regeneron has been quietly preparing for approval of its own new cholesterol drug, a niche antibody meant to treat a narrow slice of patients not covered by Praluent, the biotechs original PCSK9 inhibitor. Last year, the company reported topline, pivotal data. Last week, a BLA submission for the drug, known as evinacumab, was accepted andgivenpriority review by the FDA.

And today, in theNew England Journal of Medicine,Regeneron published the full data from the pivotal study supporting the application, showcasing some of the first significant cholesterol reductions in patients with a rare genetic disorder calledhomozygous familial hypercholesterolemia and pointing toward a therapy that could yet have broader applications.

As far as homozygous patients, this is a great, great advance, Evan Stein, a University of Chicago cardiologist who has studied the condition for over 40 years and was not involved in the paper, toldEndpoints News, for a very difficult and high-risk group of patients who need additional therapies.

In the Phase III trial, 65 patients with the condition, often shorthanded as HoFH, were randomized to receive either placebo or evinacumab. Praluent and its Amgen-developed rival Repatha treat high cholesterol by increasing the amount of LDL receptors on the liver, where they sap up the LDL cholesterol soaking in the blood. But because patients with HoFH have mutations that leave them with no functioning LDL receptors to begin with, their cholesterol levels dont come back to normal.

PCSK9 inhibitors, statins and other drugs have helped these patients blunting what could once be a fatal disease but most have continued to have elevated cholesterol and some continue to need to filter their blood with aphersis every two weeks, Stein said.

Yet in the Regeneron study, patients who received evinacumab saw their LDL levels fall by 47% over 24 week, while those in the placebo rose by 1.9%. In an accompanying NEJMeditorial, Wageningen University Sander Kersten noted that may mean patients wont need apheresis. The results of this trial are great news for patients with homozygous familial hypercholesterolemia and may reduce the need for invasive treatment, he said.

Unlike PCSK9 inhibitors or inclisiran (which stops production of PCSK9), evinacumab targets a hormone called angiopoietin-like 3, or ANGPTL3. Although its still unclear why ANGPTL3 affects cholesterol, scientists studying mice and later humans in the early 2000s learned that it did, and researchers have since been trying to figure out how to turn that insight into medical interventions.

In 2013, Ionis and Genmab developed Kynamro, an antisense oligo-nucleotide that targeted a similar protein for HoFH, but the risk of liver damage was too high for it to be commonly used.

It was a terrible drug, Stein said, noting it was never approved outside the US.

By contrast, side effects were virtually non-existent for evinacumab, Stein said. Adverse events were more common in the placebo group, where 81% had an AE, than in the treatment, where 66% did. There were two non-fatal serious adverse events in the treatment group: a suicide attempt and urosepsis, a kind of sepsis cause by a urinary infection. Five patients on the treatment arm saw an influenza-like illness but no patients on placebo did.

Still, there was room for further research. Stein said that the group most unaddressed by current therapies was kids, yet the Regeneron study excluded patients beneath the age of 12 and only included 2 patients between ages 12 and 18.

Thats where the greatest need for treatment is, he said. It would be great, if this could be extended down to children.

For Regeneron, the immediate goal-line is the FDA decision, which is due by February 11. Still, Kersten argued the study also raises a larger question: whether evinacumab will have applications in patients beyond HoFH which affects just 1 in 160,000 to 1 in 300,000 people.

That would mean both greater sales of Regeneron and a drug for patients who, despite statins and PCSK9 inhibitors, cant get their LDL under control. Those patients could include people withheterozygous familial hypercholesterolemia i.e. people with one functioning and one fault LDL receptor who often, but not always, respond to existing treatments.

Stein, though, argued that the drug would have to be easier to administer for that to happen. It currently has to be infused by IV once per month. HoFH patients will accept that, but others more addressed by current therapies wont.

Long-term, Stein is looking at new methods that could bring a one-and-done fix. He pointed to Verve and their recent animal study using CRIPSR base editing to fix a different cardiovascular condition.

The holy grail may be doing gene replacing or knocking out a gene or modifying it, he said. But were a long way from that.

View post:
Regeneron flashes 'great advance' in the NEJM for that other cholesterol drug sitting at the FDA - Endpoints News

Asthma is a chronic respiratory disease that affects more than 25 million people in the US. Asthma generally causes swelling of your airways, making it harder to breathe and causing symptoms like coughing.

However, there are many different types of asthma, like allergic or occupational asthma, that can have a variety of symptoms. Finding out which type of asthma you have can help you figure out the best way to treat it.

Here is what you need to know about the different types of asthma and how each is treated.

Allergic asthma is the most common type of asthma, and affects about 60% of asthmatics in the US. If you have allergic asthma, your symptoms, like coughing or struggling to breathe, are triggered when you breathe in allergens.

Some of the most common allergens are:

When you are exposed to these triggers, your immune system interprets them as harmful invaders and releases antibodies that cause your airway to swell up and become narrower, making it harder for you to breathe.

Your doctor can determine what allergen triggers your symptoms by doing blood or skin tests. If you have allergic asthma, you will need to avoid allergy triggers and you may need to take a prescription medicationlike Montelukast (Singulair), which helps decrease the inflammatory response that tightens airways.

Your doctor may also suggest allergy shots, which slowly introduce small amounts of an allergen into your body so that you gradually build up a tolerance. You may also need an albuterol rescue inhaler, which can quickly open your airway during an asthma attack.

Exercise-induced asthma is a more mild form of asthma in which your symptoms only arise after exercising.

"Symptoms do not start during exercise when the airways are dilated, but rather 10-15 minutes after when adrenaline levels, which help dilate the airways, come down," says Arjan Flora, MD, a professor of pulmonology at the University of Cincinnati.

You are most likely to have asthma symptoms like chest tightness or wheezing after exercising in cold, dry air, since it can make your airways swell and constrict.

According to Flora, the best ways to prevent exercise-induced asthma are:

And be sure to always carry an inhaler when you know you are going to be working out.

If you have cough-variant asthma, your main asthma symptom is a persistent dry cough. It's typical not to have other asthma symptoms like shortness of breath or wheezing.

"Treatment for cough variant asthma is largely the same as for regular asthma, using the same medications," says Neil Schachter, MD, a professor of pulmonary medicine at the Icahn School of Medicine at Mount Sinai.

This includes daily corticosteroid inhalers like budesonide (Rhinocort) and flucytosine (Flovent) to reduce swelling in your airways and an albuterol rescue inhaler for flare-ups.

"However, the most important feature of treatment is making sure that the diagnosis is correct," Schachter says. This is because other conditions like hay fever or acid reflux can also cause a chronic cough. Discussing your symptoms with your doctor can help rule out other possible conditions.

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease that prevents your airways from expanding properly, leaving some air trapped inside your lungs when you exhale. COPD symptoms usually begin in middle age and the main symptoms are shortness of breath, coughing, and excess phlegm.

If you have asthma-COPD overlap (ACO), you may exhibit all the symptoms of COPD along with typical asthma symptoms like wheezing and chest pain. ACO can cause attacks that are especially severe and can lead to hospitalization.

The most common cause of COPD is exposure to cigarette smoke, though some people may develop the condition after long-term exposure to irritating gases or fumes like car exhaust. By the time your symptoms appear, "the lungs are frequently damaged beyond repair," says Schachter. This means that while you can get your symptoms under control, you generally can't stop the disease from progressing.

Though ACO can be more serious than asthma, "in many ways the treatment is the same," Schachter says. This can include taking a long-acting airway opener like Singulair, a corticosteroid inhaler like Pulmicort, and an albuterol rescue inhaler for attacks. You may also need to add on additional medication to prevent mucus build-up.

Occupational asthma occurs when you develop asthma symptoms after being exposed to irritating substances like chemical fumes, animal waste, or smoke in your workplace. There have been over 250 different agents identified that can trigger occupational asthma.

Occupational asthma develops when you regularly inhale substances that can irritate your lungs, which leads to swelling of your airways and difficulty breathing. This irritation can be caused by an allergen, like animal dander or plant substances, or a universally irritating substance, like chlorine gas, chemicals in detergents, or metals like platinum.

According to Flora, some of the most high-risk jobs for exposure to allergens are:

The most high-risk jobs that may expose you to general lung irritants are:

The best way to prevent and treat occupational asthma is for companies to provide protective gear and train workers to safely handle irritants. Under the Occupational Safety and Health Administration (OSHA) guidelines, your employer is legally required to offer you these protections. You can also meet with your doctor to come up with an individual safety plan and get standard asthma medications.

Nocturnal asthma occurs when your asthma symptoms get significantly worse at night. Nocturnal asthma is common and can happen along with any type of asthma, including allergic or non-allergic.

The symptoms of nocturnal asthma are the same as regular, daytime asthma, but you may also experience symptoms like daytime sleepiness and frequent waking in the night. This is because frequent bouts of nocturnal asthma can interfere with your natural sleep schedule and lower the quality of your sleep.

Experts aren't sure why asthma symptoms can become worse at night, but one factor may be your hormones. In particular, levels of a hormone called histamine can spike while you are asleep , which can lead to swelling of your airways and awaken you from sleep.

"Additional complicating factors include dust mites and pet dander which can be in bed sheets, pillows, and mattresses," says Flora. So if you have allergic asthma, you may need to wash your bedding more often and keep pets out of the bedroom to fight off nighttime symptoms.

Non-allergic asthma occurs when your asthma symptoms are triggered by factors unrelated to allergens like pollen and dust. Non-allergic asthma generally starts later in life most people over 40 who develop asthma for the first time will have non-allergic triggers.

Experts are not certain why non-allergic asthma develops, but having repeated infections in your airway like bronchitis can increase your risk of non-allergic asthma, Flora says.

There are many possible triggers for non-allergic asthma, including:

The symptoms of non-allergic asthma are essentially the same as allergic asthma, including chest tightness, coughing, and difficulty breathing. After having an allergist rule out the possibility of an allergy, your doctor may work with you to identify your triggers. The treatment is also similar to allergic asthma, using long-term preventative medications and fast-relief inhalers.

If you find yourself having asthma symptoms, it's important to meet with a doctor as soon as possible to help get your symptoms under control.

Monitoring your own symptoms can also help out with diagnosis, Flora says. "Keeping a diary of onset of symptomatic episodes with potential triggers/exposures, time of day, location (ie work, outdoors), and the presence of other medical conditions can help you and your doctor discover what type of asthma you have and how you may prevent symptoms from occurring."

See the original post:
7 types of asthma and how to treat each one - Insider - INSIDER

CARLSBAD, Calif., Aug. 20, 2020 /PRNewswire/ --Qualigen Therapeutics, Inc. (NASDAQ: QLGN) (Qualigen or the Company) announced today that the United States Patent and Trademark Office has issued patent No. 10,744,257 entitled "Devices and Methods for On-Line Whole Blood Treatment" regarding the Company's Selective Target Antigen Removal System (STARS) technology.

STARS is a DNA/RNA-based treatment device candidate for the removal of viral and tumor-produced compounds from a patient's blood. The STARS technology utilizes a filtration cartridge designed for use in a standard dialysis machine, and contains aptamer-coated microparticles that bind to specific agents in circulating blood for targeted removal.

"This patent strengthens our intellectual property portfolio and increases our number of issued patents to 26, or 45 including jointly held patents. Our strategy is to continue to protect our proprietary technologies in the U.S. and globally," said Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "Although STARS is in the early stages of development, our in vitro studies have demonstrated encouraging proof-of-concept results and we look forward to advancing this program as a target-and-removal therapy for a broad range of diseases."

The STARS development program utilizes technology and expertise from the Company's FastPack point-of-care diagnostic system, which has been in use worldwide for nearly 20 years for the detection of cancer and other diseases. The Company plans to develop STARS for cancer applications to remove inflammatory factors and inhibitory checkpoints from blood, thus reducing pain and helping the body's immune system fight the disease, as well as for infectious diseases to remove viruses and other foreign agents.

About Qualigen Therapeutics, Inc.Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating viral-based infectious diseases, including COVID-19. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

Forward-Looking StatementsThis news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the Company's intellectual property protection intentions and potential future development, testing and launch of STARS and other product candidates. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Company's in-licensed patent applications; that such patents, if any, and the Company's current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products; that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products generally, particularly in view of COVID-19-related deferral of patients' physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPackinstruments on which the Company's SARS-CoV-2 IgGtest kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company's SARS-CoV-2 IgG test. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available atwww.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Qualigen Therapeutics, Inc.

Home

Read more:
Qualigen Therapeutics Announces Issuance of STARS Technology Patent by the US Patent and Trademark Office - PRNewswire

LOS ANGELES For Adam Winney, a 26-year old with Type 1 diabetes, grocery shopping during the early days of a pandemic was an infuriating task. Everything was sold out, except for the one type of food he couldnt eat.

The only things left were carbs, carbs, carbs, the Van Nuys resident said. Ive never been more furious than back in March.

Winneys disease has deprived his body of insulin, a hormone thats needed to turn the sugar in carbohydrates into energy. Without it, his blood sugar can spike to dangerous levels, eventually leading to serious health problems like cardiovascular disease, nerve damage and kidney failure.

But the insulin pens he relies on to keep his body in balance cost him upwards of $1,000 a month, since his health insurance doesnt cover the medication.

After the coronavirus outbreak cost him his job as a receptionist at a hair salon, that expense was beyond his reach. He went six weeks without the long-acting insulin he usually takes every day.

COVID-19 presents a unique set of challenges to the roughly 34 million Americans like Winney who are living with diabetes.

The Centers for Disease Control and Prevention says people with Type 1 diabetes are probably more susceptible to a severe case of COVID-19. Those with Type 2 diabetes the more common form that begins when people lose their sensitivity to insulin are definitely at increased risk of severe COVID-19, according to the CDC.

For instance, a study of more than 7,300 COVID-19 patients in China found that those with Type 2 diabetes needed more medical care and were nearly 50% more likely to die than patients without diabetes.

The risk of death was especially high for people who had trouble controlling their blood sugar, researchers reported. Another study of more than 1,200 COVID-19 patients in the U.S. found that the mortality rate for those with diabetes or high blood sugar was 29%, compared with 6% for those without diabetes.

The extent to which you control your diabetes is a risk factor, said Dr. Daniel Drucker, a senior scientist at the Lunenfeld-Tanenbaum Research Institute at the University of Toronto. Theres a lot we can do about that, by making sure that your diabetes is optimally controlled.

Insulin is essential for keeping blood sugar in check, but the pricey medicine is harder to get if a job disappears, along with the health insurance that came with it.

The cost of insulin varies from patient to patient. It depends on the type of insulin they need some take effect within 15 minutes; others last more than a day _ as well as the dose. Some insurance plans pick up more of the tab than others.

The financial strain brought on by the pandemic has forced Royce Jonathan Miller of Yuba City to consider rationing the insulin he takes for Type 1 diabetes. He has kept his job as an optician at Walmart, but since his father-in-law lost his job at a maintenance company that closed operations due to the pandemic, Miller has become the sole provider for the four people in his household.

Miller has an insulin pump, which uses a tube to continuously deliver a small amount of insulin directly to the pancreas. He is supposed to change out the pieces that connect to his body every three days. Lately, hes been wondering if thats absolutely necessary.

Im starting to think, I can stretch that up for two cycles, every six days, and hopefully it doesnt get infected, Miller said. But I do realize that if I am to make myself sick and wind up in the hospital, that will be a bigger burden.

A nationwide survey of 5,000 people with diabetes conducted for the American Diabetes Assn. found that one in four have rationed supplies to cut the cost of their diabetes care since the start of the pandemic.

Now is not the time to let up on helping these individuals manage their disease, because it may in fact be helpful in preventing them from getting severe COVID-19, Drucker said.

People with Type 2 diabetes may face even greater hardship in affording their insulin, said Dr. Francisco Prieto, a family health physician in Sacramento.

Not everyone who has Type 2 has to take insulin, Prieto said. Those who do are typically folks who either have the most severe cases of diabetes or have failed all the previous oral and injectable treatments. That means they may need to take even more insulin on a daily basis than Type 1 patients, he said.

Since 2019, 11 states have set limits on the amount insurance companies can set as co-payments for insulin. Each of those states has enacted price caps ranging from $25 to $100 per month since the coronavirus outbreak took off in March.

California may soon join the list. In February, Assemblyman Adrin Nazarian, D-North Hollywood, introduced a bill that would cap insulin copays at $50 for a 30-day supply, or $100 per month. It passed in June by a 64-4-11 vote, but the Senate Health Committee has not scheduled a hearing that would allow the bill to move forward.

Winney said a price cap would give him some peace of mind. These days he relies on free samples provided by one of his doctors, but that generosity may not last.

I see that as an incentive to finally change insurance, he said.

Ensuring an affordable supply of insulin would help people with diabetes manage their disease better, said Brandi DaVeiga, a stay-at-home mom in Lakewood with Type 1 diabetes. She has good coverage now through her husbands health insurance plan, but when she was between plans three years ago, she began skipping insulin doses to make her supply last longer. On several occasions, her blood sugar levels rose dangerously high, and she ended up in the emergency room.

Its really stressful, she said of managing diabetes during a pandemic. And that doesnt help your blood sugar.

The fact that people with diabetes are rationing their insulin when they need it most points to larger problems with health care access in this country, Drucker said.

COVID-19 is reminding us of the importance of doing everything we can in our vulnerable, at-risk populations, he said. Lets do everything we can to optimize their health because that may, in turn, reduce their risk of having a bad outcome with this virus.

Here is the original post:
Amid COVID-19 pandemic, people with diabetes struggle to get insulin - Press of Atlantic City

Vulvar melanosis is a common pigmentary change that accounts for most pigmented vulvar lesions. It presents as single or multiple asymptomatic macules or patches of varying size and color that may be asymmetric with poorly defined borders. The differential diagnosis of melanocytic lesions includes melanoma, which creates anxiety for patients and the physicians who diagnose the condition and treat the patients.To evaluate the clinical and dermoscopic features of vulvar melanosis and their changes over time.In this cohort study, patients with vulvar melanosis were recruited and followed up in the Department of Dermatology, University of Florence, Florence, Italy, between January 1, 1998, and June 30, 2019. Data on patient characteristics and on both the clinical and dermoscopic features of the vulvar lesions were collected. Each lesion was photographed clinically and dermoscopically at initial evaluation and at annual follow-up visits.The clinical, dermoscopic, and histopathologic features of vulvar melanosis and their changes over time.This cohort study included 129 women (mean age at diagnosis, 46 years [range, 19-83 years]) with vulvar melanosis. A total of 87 patients (67%) with vulvar melanotic lesions were premenopausal, and 84 patients (65%) had received some type of hormone therapy. The most frequent location for vulvar melanosis was the labia minora (55 [43%]), followed by the labia majora (33 [26%]). In 39 of 129 cases (30%), the lesions increased in size and changed color after initial evaluation but ultimately stabilized. No malignant evolution was documented in any patient during a median follow-up of 13 years (range, 5-20 years).This study suggests that vulvar melanosis was a benign entity, and changes in lesions over time did not signify malignant transformation. An association between hormonal status and vulvar melanosis may be hypothesized.

PubMed

Continue reading here:
Clinical and Dermoscopic Features of Vulvar Melanosis Over the Last 20 Years. - Physician's Weekly

Valerian "does work on the (gamma-aminobutyric acid) receptor" that controls excited neural activity, Dasgupta said.

Warm milk and golden milk tea

Thanks to the tryptophan, calcium and magnesium in dairy, drinking warm milk before bed may help you sleep better. The warmth makes the beverage more soothing and easier to digest, Dasgupta said.

"Tryptophan's the amino acid that goes on to produce things like melatonin," he said.

"We know that melatonin is a natural hormone in your body produced by the pineal gland. And it's secreted at night and it really is part of helping you try to get that good night's sleep."

Golden milk is a traditional Indian drink with milk, cinnamon, ginger and turmeric and turmeric is rich in the component curcumin. Curcumin has anti-inflammatory effects and the potential to treat symptoms of anxiety and depression, which can interfere with sleep.

"Turmeric has also been associated with good sleep," but how inflammation affects sleep hasn't yet been fully defined, Dasgupta said. "But anything that helps with pain, with anxiety or induces some form of muscle relaxation can always be helpful with getting good sleep."

Lemon balm tea

Follow this link:
Tea, milk and other drinks to help you sleep (and some that will hurt) - Martinsville Bulletin

Dignity Health (Wikimedia photo via dailycal.org)

The California congressional delegation is deeply alarmed by proposed new healthcare rules governing the affiliation between the University of California and Catholic hospital systems that operate under religious restrictions.

Hospitals such as Dignity Health and St. Joseph Health adhere to the Ethical and Religious Directives (ERDs) set by the U.S. Conference of Catholic Bishops, not by medical professionals, New Ways Ministry reported last June. Dignity Health operates by the ERDs at 17 out of 31 of their hospitals.

According to the ACLU, NCLR, and National Health Law, Contract language explicitly states that students and providers are restricted by Catholic Directives.

The ERDs do not allow the prescription of any FDA-approved methods for preventing pregnancy including sterilization, elective abortion; assistive reproductive technology such as in-vitro fertilization (IVF) or the use of a surrogate for pregnancy; gender-affirming care such as hormone replacement therapy or surgery or physician-assisted aid in dying, The California Aggie reported June 5. Some argue that partnering with Dignity restrict care to LGBTQ+ people, women, others argue more are harmed by not partnering.

A previous attempt to expand Dignity Healths affiliation with UC San Francisco (UCSF) was called off last year after 1,500 UCSF doctors and hospital staff signed apetitionopposing the proposed expansion. The UC Working Group on Comprehensive Access (WGCA) was formed to find a way forward but failed to reach a consensus.

In August 2019, the WGCA presented two options: UC Health-backed Option 1 would allow existing affiliations to continue, understanding that some people might be denied care because of the hospitals adherence to religious doctrine. Option 2 would discourage the continued affiliation.

Evan Minton (Photo courtesy ACLU)

Evan Minton, a longtime California politico chair of the California Democratic Party LGBT caucus, was among the LGBTQ advocates who argued against the expanded relationship between UCSF and Dignity. He sued Dignity Health after his hysterectomy was cancelled because they learned he is a transgender man, about which he testified before Congress. The ACLU, which is representing him,argues that hospitals should not be able to pick and choose the care they provide to individual patients.

According to the student-run The Daily Californian,Dignity Health spokesperson Dan Loeterman said Dignity Health provides specialized services such as pediatric trauma programs, cancer treatment programs and behavioral health units that would not otherwise be available without the partnerships between UC Health and Dignity Health. We are deeply committed to providing care to everyone, regardless of who they are, said Loeterman.

UCSF noted in a statement that about half of the states doctors are trained through the UC system and without training at outside entities such as Dignity Health, UC would have to reduce its health-training enrollment, DailyCal.org reported.

Meanwhile, there is some concern the coronavirus pandemic may impact the Regents decision. After all, Catholic health systems control one in six hospital beds and are often the only location for treatment in some rural areas, New Ways Ministry reported last June 17.

The California congressional delegation wanted to register their disapproval.

In their Aug. 5 letter to UC President Dr. Michael Drake and the UC Regents, 39 out of 45 members of the Democratic delegation expressed serious concerns over UCs affiliations with hospitals and providers that impose religious restrictions limiting medically necessary care. The consequences of denying this care are serious and can even be life-threatening, they wrote. (See the letter below)

Led by U.S. Reps. Barbara Lee (D-Oakland), Julia Brownley (D-Westlake Village), and Mark Takano (D-Riverside), the letter, issued with the backing of a coalition that includes NARAL Pro-Choice California, Equality California, and the ACLU of California, noted that many of the signers strongly oppose the Trump administrations Refusal of Care Rule, which they describe as a dangerous, discriminatory regulationdesigned to allow health care institutions and providers to deny patients information and treatment based on personal religious or moral beliefs.

Given the Trump administrations repeated attacks on access to evidence-based health care, the members wrote, it is deeply alarming that the University of California, which has long been a national leader in comprehensive reproductive and LGBTQ-inclusive care, would be willing to involve its providers and patients in arrangements that subject them to religious rules that hold that basic reproductive health care is impermissible, and that directly exclude LGBTQ patients. Reproductive and LGBTQ-inclusive care is fundamental, basic health care, and we in California should stand strong in protecting it.

They strongly urge the Board to vote against Option 1. Option 1 does not require that contracts with outside health systems affirmatively state that religious directives will not apply to UC providers and students. It also does not state that hospital policies prohibiting gender-affirming services for transgender people or reproductive health services violate UCs non-discrimination policy, they wrote.

The delegation also rejected the proposition that the affiliation is necessary to expand health care access to underserved communities. In fact, hospitals with Catholic religious directives often prohibit many types of medical services that communities of color critically rely upon, particularly in the areas of reproductive and LGBTQ-inclusive health, where some of the deepest racial health inequities exist. Indeed, patients of color, low-income patients, people living with HIV and AIDS, and others who experience health disparities and systemic barriers to health care access are most in need of science-based, comprehensive care that is not limited by religious restrictions.

Moving forward with Option 1, will send a message to the nation that it is permissible to impose such limits on care, just as the Trump administration has sought to do with the Refusal of Care Rule, the delegation wrote, urging the Regents to vote to reject Option 1 and contracts that impose religious restrictions on UC providers and patients.

Rep. Mark Takano (screen grab of Takano online statement on Trump impeachment)

We, as members of the California delegation, are fighting against members of the Trump administration but were really aghast at the idea that within California, which should be using all of its muscle to ensure that discrimination does not occur in healthcare, Takano told the Los Angeles Blade. The way they push back on this is theyre saying they need to reach more people of color and low-income people.

Takano also noted that the LGBTQ community in Riverside County and all over low income areas Latinos and African Americans, in particular dont have access to HIV counseling and healthcare services.

This is still one of the most significant healthcare challenges the continued spread of HIV among low income people and people of color who may not have access to or may not have even heard about PrEP, Takano said. And this cannot be solved by entering into discriminatory contracts that will inhibit the ability to reach out to these populations. So, I reject the notion that theyre going to reach more low-income people and people of color who need healthcare.

Takano challenged UC Health to come up with alternatives. We should not be stuck with providers who insist on discrimination, he said.

This really got brought to the Regents attention because UC San Francisco was trying to get into a four- hospital agreement with Dignity Healthcare. But we blocked them, UC Board of Regents Chair John A. Perez told the Los Angeles Blade. It was clearly the pattern of discrimination against LGBT folks, in particular transgender folks, but also the limitations on reproductive healthcare.

UC Board of Regents Chair John A. Perez, California Assembly Speaker Emeritus (Photo via Regents)

The issue is personal for Perez. I have a friend who went into emergency labor and was refused a medically necessary tubal ligation, which put her in very dangerous circumstances, said Perez, an issue he addressed in open session. If you got an emergency room open to obstetrics and somebody comes in, in emergency labor, for you to put these constraints that are not based on science or medical best practice is fundamentally at odds with our obligation and our standards and our values as a public university hospital system.

Perez, who notes that he is one of three out LGBTQ Regents, is adamantly opposed to Option 1.

I will do everything in my power to make sure Option 1 is never adopted, Perez said. I believe that running a hospital or a health system and making decisions based on anything other than science the medical best interest of the patient is tantamount to the corporate practice of medicine, which California expressly prohibited by law.

Perez notes that the thorny issue raised by Option 1 has not yet been put forward. Meanwhile UC Health is focused on fighting the COVID-19 crisis. He disputes the notion of temporarily disregarding state and UC non-discrimination laws and core values to expand healthcare to low income people of color.

Were serving not only our patients, but were providing broader assistance to folks in other communities that arent part of our hospitals, Perez said. So, for example, Imperial County is about the most significantly impacted County in the state and were taking patients from Imperial County not only in San Diego and Irvine, but as far away as Davis. Were right now focused on direct patient care and direct research and helping turn the corner on COVID. And I think that really does speak to why nobody within the health operations has put this forward at this point.

More comments and the congressional letter:

University of California clinicians should not have their hands tied from providing reproductive and LGBTQ inclusive care because of religious directives, saidRep. Lee.While it is critically important to expand care to underserved communities, it should be comprehensive, not restricted care that is provided.

It is imperative that all Californians have access to quality and affordable healthcare, regardless of their gender or sexual orientation, saidRep. Brownley.The personal belief of healthcare providers should not be used to provide substandard care to classes of individuals. The University of California needs to make sure its actions do not narrow or restrict necessary healthcare, particularly for women and LGBTQ+ individuals, who have long faced roadblocks to getting the full healthcare they need and have a right to.

The University of California should not be limiting access to healthcare for LGBTQ+ people, women or other marginalized people who already face tremendous barriers to treatment but proposing to do so during a public health crisis is particularly offensive, saidEquality California Executive Director Rick Chavez Zbur.The UC is toeing a dangerous line by entertaining affiliations with hospitals that have long records of refusing LGBTQ+ inclusive and reproductive care. As Californians, we must as we always have set the example that everyone deserves care, regardless of religious belief, sexual orientation, the color of your skin or your gender identity.

California is a national leader when it comes to safeguarding and expanding reproductive freedom and LGBTQ-inclusive care which makes affiliations between the University of California and hospitals like Dignity Health, that categorically refuse to provide basic reproductive and gender-affirming care, all the more troubling, saidShannon Hovis, Director of NARAL Pro-Choice California.Discriminatory restrictions imposed by Catholic health systems are an affront to California values, plain and simple. As the fourth-largest healthcare provider in the state, the UC has a public and moral responsibility to provide high-quality, evidence-based care, free from discrimination. With so much at stake for reproductive freedom and equality in 2020, we demand that the UC Regents take action to ensure that every body is able to access the care they need.

Original post:
Takano 'aghast' at proposed UC affiliation with restrictive Catholic hospitals - Los Angeles Blade

Julie Rowland, APRN, is now accepting new patients at Baptist Health Family and Occupational Clinic-South located at 8600 South 36th Terrace.

Rowland joined Baptist Health in the Spring, but has been a nurse practitioner in the community for four years.

Rowland earned an advanced practice nursing degree from Simmons College in Boston in 2015 and a Bachelor of Science in Nursing from the University of Central Arkansas in Conway in 2011. She has more than 13 years of nursing experience, including working in intensive care and cardiology units across the state. Rowland says her experience in hospitals inspired her to go back to school to become a nurse practitioner.

"When you treat a patient in the hospital, you usually see them at their worst, but in the clinic, you have the opportunity to educate patients at all stages of life and help them achieve their health goals," Rowland said.

Rowland provides wellness exams, preventive care and treatment for acute illness for patients who are school-age and older. Her clinical interests include diabetes, depression and preventive medicine. As the wife of a type 1 diabetic, Rowland knows firsthand how to help patients manage blood sugar levels with insulin, diet and lifestyle to prevent complications. She takes a holistic approach to patient care and values the time she spends discussing a patients individual needs.

"I like to try to do things as naturally as possible such as addressing a patients hormone and vitamin deficiencies, and overall lifestyle before adding any medications or making any changes," Rowland said.

Rowland was born and raised in Charleston. She is married with three daughters. To make an appointment with Rowland or to learn more about services provided, please call 1-888-BAPTIST.

Dr. Megan Minniear-Corrons, M.D., recently joined Mercy as a family medicine physician at Mercy Clinic Primary Care, a new Mercy location in Clarksville.

The new clinic opened Aug. 3 at No. 2 Medicine Drive in Clarksville.

Corrons is a graduate of the University of Arkansas for Medical Sciences in Little Rock and graduated summa cum laude with a bachelors degree in biology from the University of the Ozarks in Clarksville.

Corrons said because Mercys mission is to "bring to life the healing ministry of Jesus," she hopes to show the love of Christ to each patient every day.

"I chose family medicine as a way to give back to my community, because I want to have personal relationships with my patients," Corrons said. "I want the decisions that are made regarding their health care to be a collaborative effort. I want them to feel that their concerns have been heard and together we have decided on a plan for them."

Corrons is a member of the American Medical Womens Association and American Academy of Family Physicians. She has served as a representative on the Family Medicine Interest Group M4 and on the Hospital Auxiliary at Johnson Regional Medical Center in Clarksville. In addition, she has served on the fundraising and activities committees and as Sunday school and vacation Bible school director at First United Pentecostal Church of Clarksville.

She and her husband, Nathanial Corrons, live in Clarksville and attend GracePoint Church in Clarksville.

Mercy Clinic Primary Care in Clarksville is open from 8 a.m. to 5 p.m. Monday-Friday. Phone: (479) 705-2124.

The rest is here:
People In Business - Times Record

Alzheimer's is a scary disease because it means not remembering loved ones or how to do basic things like getting dressed. Until recently, doctors didn't know what caused it and couldn't offer much help. However, now that's changed.

Just like a roof with dozens of holes can only work if all of them are repaired, Alzheimer's has dozens of causes that must all be addressed, according to Dr. Dale Bredesen who has researched the causes and treatments of Alzheimer's Disease for more than thirty years.

"Let's make dementia a rare problem. Let's make Alzheimer's a rare disease, just as it should be," Dr. Bredesen told CBN News

His book,The End of Alzheimer's Disease:The First Protocol to Enhance Cognition and Reverse Decline at Any Age lists the many different causes of Alzheimer's and describes how his Bredesen Protocol can prevent the disease and has been shown to reverse symptoms in people with mild to severe cognitive decline.

Click HERE to see Lorie Johnson's full interview with Dr.Dale Bredesen about The End of Alzheimer's Program.

Sally Weinrich reversed her symptoms when she started the Bredesen Protocol after being diagnosed with the early stages of Alzheimer's Disease.

"You can get your cognition back, and that's what counts," she told CBN News.

She has been on The Bredesen Protocol for four years and has remained mentally sharp the entire time.

"I thank God for everything," she said, "From helping me hear about Dr. Bredesen, from the chance to talk to you and share it with others, because that's God's wish, for others to have health, and to help me appreciate and treasure my loved ones even more, who've been very instrumental and critical in my reversing Alzheimer's."

She says her husband Martin discovered The Bredesen Protocol through an internet search and helped his wife get started on it.

The First Step

The first step of the Bredesen Protocol involves getting what's called a "cognoscopy."

"We recommend that everyone 45 years of age or older, consider getting a cognoscospy," Dr. Bredesen said, "Especially for anyone who has any Alzheimer's or dementia in their family. Get checked out early and get on prevention."

A cognoscopy tests for each of the dozens of Alzheimer's risk factors. It's a simple procedure that involves giving blood and taking a quick, online quiz that measures a person's mental capacity compared with other people who are the same age. Since each person is different, the results will vary.

The online test measures things like memory and reaction time. The blood tests measure levels for good things like Vitamin D, Magnesium and Zinc as well as bad, such as toxins and inflammation.

DNA is Not Your Destiny

The cognoscopy also tests your genetic risk. Approximately 75 million Americans, roughly one in four people, carry one copy of the ApoE4 gene, which equates to a thirty percent increase in the risk of Alzheimer's. Approximately sevenmillion Americans carry both copies of the gene, which means they have more than a fifty percent risk of developing Alzheimer's Disease. Two-thirds of Americans with Alzheimer's Disease carry one or both copies of the ApoE4 gene.

Three-quarters of Americans carry two copies of the ApoE3 gene, which means they have a nine percent chance of developing Alzheimer's during their lifetime.

Dr. Rebecca Ryder is one of the more than 1,500 physicians who has trained under Dr. Bredesen and prescribes his protocol to her patients.

"It is a complicated disease," she said."There is no one magic bullet."

Until now, too many people didn't want to know whether they carried one or both copies of the ApoE4 gene because they felt there was nothing they could do about it. However now the opposite is true. People should know early whether they carry the gene because with early intervention science now tells us it's possible to silence it, or "turn it off."

"There are some things we can not control. Our genes. The genes we were dealt with," Dr. Ryder said, "But there's a whole field called epigenetics which says how our genes are translated. So those lifestyle factors, your diet, your exercise, all that affects what genes are promoted or not promoted for your health."

Your Personal Program

Patients can learn the nearest location of a health care professional who has trained in the Bredesen Protocol on the website. Patients can also work with their primary care physician to prescribe the blood work needed for a cognoscopy. Patients can also get a cognoscopy by working directly with practitioners at Apollo Health, the brain health community founded by Dr. Bredesen.

Dr. Ryder says she reviews the results of a patient's cognoscopy with them.

"Most patients will have a combination of things," she explained," Like they'll have a little bit of hormone, a little bit of blood sugar problems, maybe a little bit of toxin exposure."

Based on the results of the cognoscopy, the patient is prescribed a tailor-made program using diet, exercise, sleep, stress reduction, supplements, and more.

"We've seen some good reversals of cognitive decline here," Dr. Ryder said, "I mean, I have seen the patients get better here. Not all of them. As with anything, the earlier you catch it, the better."

Success Stories

So far more than 5,000 people have started the protocol. Dr. Bredesen and his team have documented cases of patients who initially scored low on the Montreal Cognitive Assessment, or MoCA, a screening that measures brain function, who improved after adopting the protocol.

Likewise, patients who had poor EEGs, which measure brain-wave speed showed improvement and those with brain shrinkage detected on MRI scans later showed increased volume after being on the protocol.

"Those 5,000 some of them MoCA scores of zero and late stage," he explained, "Now, no surprise, the earlier you get started the easier it is to get positive outcomes. However, we have seen some people even in [the] late stages with improvement."

Dr. Bredesen published research studies documenting cases with before and after evidence of improved cognition, including Sally Weinrich's.

"Life's good," Sally said, "So no matter what stage you're at, or if you have what society calls 'aging problems,' I'd encourage all your viewers to just do it. It's worth it."

Meanwhile, Dr. Bredesen's research continues.

"We're in the midst of the first trial in history in which, instead of predetermining a treatment, saying, 'OK, we're going to treat with this drug or that drug, we're instead looking at all of the different contributors to the cognitive decline for each person, and then addressing those," he continued, "And this is the way of the future. This is the way people will be treating cognitive decline for years to come."

So instead of using a single drug to treat Alzheimer's Disease, it appears a customized, multi-pronged approach to treatment and prevention could be the best strategy to fight this scourge.

Here is the original post:
Alzheimer's Doctor: Here's How to Avoid Getting It or Reverse Symptoms if You Already Have It - CBN News

The information provided on the show is for general information purposes only. If you have a health problem, medical emergency, or a general health question, you should contact a physician or other qualified health care provider for consultation, diagnosis and/or treatment. Under no circumstances should you attempt self-diagnosis or treatment based on anything you have seen on the show.

A good beauty regime doesnt just involve what we put ON our bodies we also need to be mindful of what we put in them! With some diet suggestions, lifestyle changes and supplements from Jamiesonto help is registered dietitian and nutritionist Nishta Saxena.

Find Nishtas recommendations below, and watch the video above for more.

Keeping out hair, skin and nails healthy is key to achieving that glow from the inside out. Jamieson Advance Hair, Skin + Nails is an advanced, once-a-day, multivitamin formula that helps promote thicker hair, stronger nails and healthier skin thanks to a high-potency dose of Biotin, and 21 other key ingredients. Biotin is a B vitamin thats known for its beauty enhancing properties, and like most B vitamins, its also beneficial for our entire body because it helps convert food into energy. Remember to check with your doctor before taking any new supplements or medication to make sure theyre right for you.

You can also get biotin in Vitamin B rich foods like eggs, fish, beef, pork, sweet potatoes, dairy products and oatmeal. Try a spinach and strawberry salad with toasted almonds and sunflower seeds for an extra boost! Not only are you getting biotin through the spinach and sunflower seeds, this salad also delivers lots of minerals and fibre.

Another great option is a broccoli and cheddar cheese fritatta, which is going to give you tons of B vitamins, thanks to the eggs and broccoli. Its also high in protein, and its great for breakfast, lunch or dinner.

Acne can be genetic, so some people are more prone to it than others. But there are still things you can do to promote healthy skin!

Staying well hydrated is key, so make sure to drink lots of water.Also, sun can really dry out the skin barrier, so during the summer months its crucial to use a good high UVA and UVB sunscreen, because not protecting your skin can really irritate it and make your acne worse.

In terms of food you want to avoid refined sugar and processed foods that cause a lot of insulin to be released in the body. And lastly, you want to focus on exercise and stress management. Stress can really impact the hormones that make acne worse, but exercise can help. It reduces stress, and brings blood flow to the skin, which helps the nourish the skin and take away some of the toxins you dont want.

Jamieson Clear Skin is designed to help improve skin tone and reduce acne inflammation. Its formulated with a unique and powerful blend of natural ingredients including Sea Buckhorn and Chaste tree, the latter of which is used in Herbal Medicine as a hormone normalizer which means it can also help relieve PMS symptoms or relieve symptoms associated with menopause. Plus, it also contains a high-potency GLA gama linoleic acid from Borage Oil, which is a fatty acid that helps reduce the inflammation commonly associated with acne.

If youre worried about wrinkles, have no fear! Some collagen in your diet can help prevent them. Collagen is a protein in the body that helps form the matrix of your skin the netting that holds it together and as we age, and women go through menopause we definitely see a reduction of collagen in our body. This leads to sagging, and a loss of elasticity in the skin

Collagen is made up of amino acids, so any foods that are high in protein are going to help make collagen foods like pork, chicken, eggs, organ meat and dairy products. Try some pork tenderloin kebabs with grilled peppers, mushrooms and vidalia onion to up your collagen intake the pork and mushrooms have all the amino acid building blocks required to make collagen, and the grilled peppers have accessory nutrients like Vitamin C which are also important for keeping your skin healthy.

In terms of a supplement, Jamieson Collagen Anti-Wrinkle is clinically proven to reduce the number of fine lines and wrinkles in 28 days. Its formulated with hydrolyzed bovine collagen which helps increase skin density and the appearance of smooth skin and its available in caplet form or strawberry flavoured liquid.

Lack of sleep can effect our mental health and our heart function and our stress hormones will go up, which may cause our body to hold on to extra fat. So what can you do? First things first, you need to prioritize sleep. Dont binge watch extra episodes of TV if its getting late go to bed! Shut all screens and blue light exposure off an hour before bed. Avoid caffeine 12 hours before sleep, because if youre a slow metabolizer of caffeine it can interrupt sleep.

You may have heard that melatonin has an important role in helping us get a good nights sleep. But what is it? Melatonin is a hormone in the body that helps regulate the sleep-wake cycle. However, some people need extra help. Thats where a product like Jamiesons Beauty Sleep could be useful! Its a safe and non-habit forming sleep aid that contains melatonin to help improve sleep quality. Plus its got two key beauty ingredients biotin and hydrolyzed collagen to help promote healthier hair, skin and nails so it really takes the idea of getting your beauty sleep to the next level!

View post:
How to achieve beauty from the inside out with diet, lifestyle and supplements - The Loop

Dr. Suzanne Slonim

Dallas Business Journalhonors Dr. Suzanne Slonim for her unique minimally-invasive fibroid practice

DAVID TAFFET | Senior Staff Writertaffet@dallasvoice.com

Dallas Business Journal has named Dr. Suzanne Slonim as one of its business women of the year. For 15 years, Slonim served as medical director of interventional radiology at Methodist Dallas Hospital before she founded the Fibroid Institute Dallas exclusively to treat uterine fibroids with a minimally-invasive procedure.

Slonim and her wife, Pam Gerber, searched locations around the country extensively before deciding on moving to Dallas. We were looking for a place to be safe, happy and welcomed, Gerber explained.

They had been living in Palo Alto, Calif. but couldnt afford to continue living there comfortably. So they looked in Miami, Washington, D.C., San Diego, Tampa and a few other cities but found the LGBTQ community in Dallas to be the most organized and most welcoming.

Gerber said she was apprehensive about the move. She had preconceived notions about Dallas, but both Gerber and Slonim quickly found Dallas to be an easy place to live. And, Slonim said, its a great place to practice medicine. Among the things she likes about Texas, Slonim added, is that the state has prohibitions against corporations practicing medicine. So Slonim joined an existing practice as an interventional radiologist.

The couple planned to stay in Dallas five years. That was 20 years ago.

While at her practice, Slonim created a niche market in uterine fibroid embolization or UFE. Fibroids are abnormal, usually noncancerous, growths in the uterus that cause severe abdominal pain and heavy periods. Instead of treating fibroids with a hysterectomy, UFE uses radiology to cut off the blood supply to the fibroid so it will shrink.

The plan to stay in Dallas just five years got derailed during year four when Slonim was named president of the medical staff at Methodist Dallas Hospital the first woman named to that position. That meant an additional six years in Dallas two as incoming president, two serving as president and two as immediate past president.

During that time, her UFE specialty grew. She said she became an amplifier for the relatively unknown, minimally-invasive procedure.

Gynecologists generally steer away from the UFE procedure because patients complain of pain afterwards. But Slonim said that is because those doctors havent managed their patients pain. She prepares patients ahead of time with medication especially for that first week as the fibroids begin to shrink.

In her first year in her own practice, about 10 percent of Slonims clients came through referrals from other doctors. Now, as her work has been recognized by area gynecologists, about 80 percent are referrals.

Slonim said removal of just the uterus can be a very bloody operation requiring transfusions. In some cases, even when a woman will eventually need the uterus removed, doctors now refer patients to her to shrink fibroids first, making the removal a much safer operation.

Today, Slonims office is the only one that specializes in only doing UFE. I feel passionate about it and love doing this procedure, she said. And shes passionate about making sure anyone with fibroids is given the option of UFE.

Although her companys nondiscrimination policy includes sexual orientation and gender identity, Slonim said shes never treated a trans man. Thats probably because fibroids are fed by estrogen, and hormone treatments block the growth of fibroids. But, she said, if a trans man with a uterus was seeking treatment for fibroids, shed assure him the finest medical care, something she said trans men and women dont always receive.

Gerber said that commitment to providing the finest care possible is one of the things she admires most about her wife, describing Slonim as a cross between an old-school family doctor and a modern physician using the latest technology.Slonims technique involves inserting a wire into a blood vessel in the patients wrist and steering it up the arm and down the torso into the uterus while monitoring the progress on a screen. That takes about a minute. Thats the latest technology part.

The old-school family doctor part and her bedside manner she may have learned from her parents, both of whom were doctors. Her father was from New Jersey and her mother came to the U.S. for college from Iraq then stayed for medical school. Slonim said her father retired when he was done paying for her medical school, but her mother, at 89, just stopped seeing patients earlier this year.

Slonim said her patients have her cell phone number and call her directly when they need her help. Gerber recalled one patient who was in pain because of a problem with a port who contacted Slonim in the middle of the night. The doctor had that patient come to their house where she fixed the problem.

During the COVID-19 lockdown, Slonims office was closed because the procedure she does, while stopping severe pain, is considered elective. So, like other doctors, Slonim quickly adopted the use of telemedicine, and she has been able to prepare some patients for upcoming procedures online.

She has reopened the office, but before doing so, Slonim said, she added machines that clean the air of mold and other pathogens to help keep her patients and staff safe. Hand washing stations are placed throughout the office.

Texas Medical Association has been great in getting us all the PPE we need, she said. And she reopened feeling her office was as safe and protected as possible.

Slonim and Gerber have been together 30 years. They met in an L.A. Bar: I want to be explicitly clear on this one, Gerber said. She asked me to dance.

They live in a townhouse in the SoHiP section of Oak Lawn with a couple of chickens out in the chicken coop Slonim had built for Gerbers 50th birthday. Slonim said she wanted fresh eggs, and they started with seven chickens. Theyre down to two including one who was injured, has recovered and is now pigeon-toed.

As for her business, Slonim who has spoken on the subject around the world and has written a number of books on the subject including her latest, Pain Free Periods, available at FibroidFree.com hopes to replicate her model in other cities with other doctors who are as passionate as she is about treating fibroids with UFE rather than major surgery.

See more here:
Business woman of the year - Dallas Voice

Novel antibody-drug conjugates (ADCs) introduce promising options for the management of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer; however, management of drug-related toxicities and optimal sequencing of HER2-targeted therapies remains an ongoing challenge, according to stakeholders who participated in a recent OncLive Scientific Interchange and Workshop.

As of 2016, approximately 3.5 million women were living with a breast cancer diagnosis in the United States, and the number of new cases of breast cancer in 2019 represented approximately 15.2% of all new cancer diagnoses. Based on data from 2014 to 2016, approximately 1 in 8 women will be diagnosed with breast cancer in their lifetime, with the largest proportion of diagnoses occurring in women between the ages of 55 and 64 years.1

HER2-positive breast cancer accounts for approximately 15% of all breast cancers.2 HER2 is a member of the ERBB family, which comprises 4 plasma membrane-bound receptor tyrosine kinases (HER1, HER2, HER3, and HER4).3 Overexpression of HER2 is identified by evaluating samples of either the primary tumor or metastatic tissue with immunohistochemistry (IHC) or fluorescent in situ hybridization (ISH). Testing guideline updates released in 2018 by the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) define HER2-positive as an IHC score of 3+, which involves strong staining of the entire membrane circumference of more than 10% of tumor cells.4 Tumor specimens with an IHC score of 2+ with weak to moderate complete membrane staining in more than 10% of tumor cells are considered HER2-equivocal and require reflex testing with fluorescent ISH to clarify HER2 status. Specimens with very slight, incomplete membrane staining in more than 10% of tumor cells (IHC score 1+) or those with no observable staining (IHC score 0) are considered HER2-negative.4 Another term, HER2-low, recently emerged to describe breast cancer with an IHC score of 1+ or 2+ with a negative fluorescent or chromogenic ISH assay. More than 50% of breast cancers may be HER2-low; those with low HER2 expression and no ERBB2 amplification may experience benefit from HER2-targeted therapies.5

Recurrence and Overall Survival Rates

HER2 positivity was historically associated with high rates of recurrence and poor survival, but the availability of trastuzumab and other HER2-targeted therapies has substantially improved outcomes.2 According to a recent analysis, the estimated 5-year survival rates are 83% for hormone receptor-negative, HER2-positive breast cancer and 89% for hormone receptor-positive, HER2-positive breast cancer. Before we had targeted agents against HER2, particularly in the curative setting, it used to be among our most virulent and rapidly fatal of breast cancers, said session moderator Joyce A. OShaughnessy, MD, of Baylor University Medical Center in Dallas, Texas. [HER2 amplification] is a very, very powerful growth and survival signal. It leads to a lot of therapy resistance right across the board.

Although OShaughnessy noted that recurrence rates for HER2-positive disease are decreasing, she estimated more than half of patients who need first-line treatment for metastatic HER2-positive breast cancer have de novo metastatic disease, which emphasizes the continued need for further metastatic therapies. In addition, central nervous system (CNS) metastases are relatively common in HER2-positive breast cancer and were identified by the stakeholders as 1 of the challenges in management of their patients. Up to 50% of patients with HER2-positive advanced breast cancer develop CNS metastases in their lifetime.6 Erika P. Hamilton, MD, of Sarah Cannon Research Institute in Nashville, Tennessee, noted that it is important to identify patients in the neoadjuvant or adjuvant setting who are at higher risk for CNS relapse and most likely to benefit from early escalation of therapy.

Standard Therapy

Several targeted therapies are approved for HER2-positive breast cancer in the adjuvant and metastatic setting, including trastuzumab, pertuzumab, lapatinib, ado-trastuzumab emtansine (T-DM1), and neratinib.7 An additional treatment option, the kinase inhibitor tucatinib, was approved in April 2020 and is indicated in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including those with brain metastases, after receiving 1 or more HER2-targeted regimens in the metastatic setting.8 This approval was based on data from the phase 3, randomized, controlled HER2CLIMB trial, which had results that showed that the progression-free survival at 1 year among adult patients with HER2-positive breast cancer (N = 612) was significantly better with tucatinib, trastuzumab, and capecitabine than with placebo, trastuzumab, and capecitabine (33.1%; vs 12.3%; HR, 0.54; 95% CI, 0.420.71; P <.001) and risk for disease progression or death was 52% lower in those with CNS metastases who received the tucatinib combination (HR, 0.48; 95% CI, 0.340.69; P <.001).9 Although the arrival of tucatinib has helped with managing CNS metastasis in HER2-positive breast cancer, Antoinette R. Tan, MD, of Levine Cancer Institute, Atrium Health in Charlotte, North Carolina, predicted that managing these patients will remain an ongoing challenge because they are living longer.

ADCs offer a targeted approach to HER2-positive breast cancer treatment, and have also shown promise for patients with heavily pretreated disease, CNS metastases, or HER2-low expressing breast cancer.10-12 ADCs consist of a recombinant monoclonal antibody molecularly bound to a cytotoxic drug (known as the drug payload) with a synthetic linker, and they combine the antibodys high specificity for a target with the chemotherapy drugs cytotoxicity.13 HER2-targeted ADCs bind to HER2 on the cancer cell surface and are internalized by the cell, after which the cytotoxic drug component is released intracellularly and exerts its antitumor effect. ADCs may also be designed to stimulate the release of drug from the target cell into the extracellular space, which kills surrounding and bystander cells that may or may not express the target antigen (ie, a bystander effect). This may also occur if the cytotoxic drug is released after binding to the antigen and before internalization.

Trastuzumab Emtansine

The ADC trastuzumab emtansine (T-DM1) was approved in 2013 and is indicated for treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination, and for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.14 T-DM1 is composed of trastuzumab linked with the chemotherapy agent DM1. This agent derives from maytansine, a plant isolate that binds tubulin and blocks microtubule assembly by hindering polymerization and enhancing depolymerization. Although the activity of maytansine is extremely potent, dose-limiting toxicities halted clinical development in early trials.15 T-DM1 resolves these toxicity limitations through a nonreducible thioether linker that prevents chemotherapy release into circulation once the linker breaks down in the tumor cell. These linkers may have minimal cytotoxicity on bystander cells. T-DM1 must be internalized by the target cell for degradation of the antibody and subsequent release of the drug to occur, and the cleaved drug product is unable to enter surrounding cells because its positively charged lysine moiety is unable to penetrate the cell membrane.16 Results from a preclinical study demonstrated that thioether linkers have lower toxicity and better potency than disulfide linkers and induce dose-dependent cell death in HER2-overexpressing breast cancer cells (SK-BR-3 and BT-474) through apoptotic and cell lysis mechanisms.17

The high efficacy and relatively good tolerability of T-DM1 have helped to establish it as a common second-line therapy for HER2-positive metastatic breast cancer.18 The phase 3 EMILIA trial randomized patients with HER2-positive, unresectable, locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane to receive T-DM1 (n = 495) or lapatinib plus capecitabine (n = 496); primary endpoints were progression-free survival (assessed by independent review), overall survival, and safety. T-DM1 was associated with significantly longer median progression-free survival (9.6 months vs 6.4 months; HR for death from any cause, 0.65; 95% CI, 0.550.77; P <.001) and overall survival at the second interim analysis (30.9 months vs 25.1 months; HR for death from any cause, 0.68; CI, 0.550.85; P <.001).19 The T-DM1 group also had a significantly higher objective response rate than the lapatinib plus capecitabine group (43.6% vs 30.8%; P <.001) and lower rate of grade 3 or higher adverse events (AEs) (40.8% vs 57.0%).

The most commonly reported grade 3 or 4 AEs in the T-DM1 group were thrombocytopenia (12.9%) and elevations in serum aspartate aminotransferase and alanine aminotransferase (4.3% and 2.9%, respectively). For the majority of patients, onset of grade 3 or 4 thrombocytopenia occurred during the first 2 cycles of T-DM1, and most were able to continue treatment with dose modifications. Serious AEs were reported for 88 patients (18.0%) in the lapatinib-capecitabine group and 76 patients (15.5%) in the T-DM1 group.19

Regarding treatment in the adjuvant setting for patients with HER2-positive early breast cancer, T-DM1 showed positive results in the phase 3 KATHERINE trial, which randomized patients to receive adjuvant T-DM1 (n = 743) or trastuzumab (n = 743) with the primary endpoint of invasive disease-free survival. Invasive disease-free survival at 3 years was significantly better in the T-DM1 group than in the trastuzumab group (88.3% vs 77.0%; HR 0.05; 95% CI 0.390.64; P <.001). T-DM1 was generally well-tolerated in this trial, with decreased platelet counts (5.7%) and hypertension (2.0%) as the most common grade 3 or higher events. Serious AEs were reported in 94 patients (12.7%) in the T-DM1 group and 58 patients (8.1%) in the trastuzumab group.20

Although survival data have not been published yet, OShaughnessy said that the data from the KATHERINE trial highlighted T-DM1 as an effective, safe option in the adjuvant setting. This is a well-tolerated, feasible regimen that were all very, very familiar with, and its an important standard of care, particularly in the curative setting, she said.

The efficacy of T-DM1 is thought to be greater in breast cancers with high and homogeneous expression of HER2, as suggested by results of a randomized phase 2 trial that compared first-line T-DM1 to trastuzumab plus docetaxel in patients with locally advanced or metastatic HER2-positive breast cancer (N = 137). In the trial, the improvements in risk for disease progression with T-DM1 were greater in patients with HER2 messenger RNA (mRNA) expression equal to or more than the median (HR, 0.3; 95% CI, 0.180.85) than in those with HER2 mRNA expression below the median (HR, 0.85; 95% CI, 0.44-1.67). Within the T-DM1 treatment arm, patients with HER2 mRNA expression equal to or greater than the median had numerically longer progression-free survival than those with HER2 mRNA expression less than the median (not reached versus 10.6 months).21

Trastuzumab Deruxtecan

Trastuzumab deruxtecan (DS-8201a) is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior antiHER2-based regimens in the metastatic setting.22 The ADC is composed of a humanized anti-HER2 antibody (trastuzumab), enzymatically cleavable tetrapeptide linker, and novel topoisomerase I inhibitor payload (DXd), which is a derivative of exatecan (DX-8951). The tetrapeptide linker, glycynglycyn-phenylalanyn-glycyn (GGFG), is decomposed by cathepsins B and L and other lysosomal enzymes that are strongly expressed inside the tumor cells.23,24 Trastuzumab deruxtecan has a higher drug-to-antibody ratio (DAR) than other ADCs, with approximately 8 molecules of DXd homogeneously conjugated to 1 trastuzumab molecule versus 2 to 4 drug molecules conjugated to the antibody molecule in other ADCs (3.5 drug molecules in T-DM1). Although a higher DAR (6 to 8) has been known to contribute to ADC instability and higher clearance, which leads to reduced efficacy and greater toxicity, the drug linker system of trastuzumab deruxtecan offers high stability in plasma and strong antitumor activity that relies on its high DAR. Unlike ADCs with a lower DAR (3.4), trastuzumab demonstrated antitumor activity in HER2-low models.23 In addition to having a higher DAR, trastuzumab deruxtecan has a DXd payload with a higher cell membrane permeability than that of T-DM1; this was shown to contribute to a bystander effect in an in vitro coculture of HER2-positive and -negative cells and an in vivo mouse model with tumors heterogeneous for HER2 expression.24

An open-label, dose-escalation, and dose expansion phase I trial evaluated safety and preliminary activity of trastuzumab deruxtecan in patients with HER2-positive, advanced- stage breast cancer previously treated with T-DM1. Analysis of the 115 patients treated with at least 1 dose of trastuzumab deruxtecan at the recommended doses for expansion showed an objective response rate of 59.5%. The most common grade 3 or higher treatment-emergent AEs were anemia (17%) and decreased neutrophil (14%), white blood cell (9%), and platelet (8%) counts, and 9 cases of interstitial lung disease or pneumonitis required discontinuation of treatment.25

The 2-part, open-label, phase 2 DESTINY-Breast01 trial enrolled patients with HER2-positive metastatic breast cancer who had been treated previously with T-DM1 (N = 184). Part 1 of the trial consisted of pharmacokinetics and dose-finding stages, and part 2 evaluated the efficacy and safety in patients treated with the recommended dose. Part 2 included a cohort of patients who had experienced tumor progression with T-DM1 and a cohort of patients who had discontinued T-DM1 due to toxicity and additional reasons other than progressive disease. The confirmed response rate (by independent central review) was 60.9% among patients who received the recommended dose of 5.4 mg/kg (95% CI, 53.468.0), and the median duration of response was 14.8 months (95% CI, 12.7not reached). The onset of response was relatively quick (median 1.6 months). Patients received a median of 6 prior cancer therapies and the confirmed response rate was 61.1% among the cohort who had tumor progression during or after receipt of T-DM1. This suggests the agent has strong activity even when HER2 is downregulated by prior targeted therapies, according to OShaughnessy. It really speaks to the noncross-resistant nature of the deruxtecan and the ability of this agent to really bind and kill cells, even with the low level of HER2 expression, she said. Some clinicians may also use trastuzumab deruxtecan in patients with a large disease burden or severe diseaserelated symptoms, according to OShaughnessy.

Trastuzumab deruxtecan may also have efficacy in patients with a history of CNS metastases, according to a subgroup analysis of 24 patients with baseline CNS metastases from the DESTINY-Breast01 trial. The overall response rate was 58.3% (95% CI, 36.677.9), including 1 patient who had a 55% regression of a metastatic brain lesion, and the median progression-free survival was 18.1 months (95% CI, 6.7-18.1). At a median follow-up of 11.1 months, 33% of patients with CNS metastases (8/24) and 26% of the overall population (48/184) experienced disease progression before the cutoff date. However, only 4 of the 48 patients with progressive disease (including 2 of 8 patients with CNS metastases at baseline) had a CNS progression.12

In the DESTINY-Breast01 trial, 57.1% of the patients who received the recommended dose had a grade 3 or higher AE. Decreased neutrophil count (20.7%) was the most common; however, the risk for drug-induced lung complications was of particular concern to the stakeholders, with 11 patients discontinuing trastuzumab deruxtecan due to pneumonitis and 5 discontinuing due to interstitial lung disease. Of the 25 reported deaths, 18 occurred during the survival follow-up period (the 47 days after end of treatment), and 2 of these were caused by situations related to interstitial lung disease, which had started during treatment.26

An analysis of 7 ongoing studies across multiple tumor types of 665 patients who received at least 1 dose of trastuzumab deruxtecan showed that 66 cases of interstitial lung disease were reported, and 13 of these were grade 3 or higher. Five patients with interstitial lung disease had a fatal outcome, and 4 of these deaths were identified as related to trastuzumab deruxtecan. Of the 665 patients, 289 were from the DS9201-A-J101 study, whose results showed that higher doses and Japanese origin may increase the probability of developing interstitial lung disease after adjustment for baseline factors, such as age, previous radiotherapy to the chest, number of previous anticancer therapies, lung metastases, and HER2 status. The study authors concluded that patients with suspected interstitial lung disease should be diagnosed early with imaging, laboratory testing, and meeting with a pulmonologist. These patients should also discontinue trastuzumab deruxtecan and, in moderate to severe cases, receive steroids.27

The interchange faculty agreed that increased awareness among clinicians and early identification of drug-related lung issues is critical. I am pretty convinced that if we catch this pneumonitis in a grade 1 or a grade 2, we can reverse it, but a lot of times its just not caught that early, said Hamilton. I think if you do get somebody with a grade 3 pneumonitis, its just beyond the point of return.

Neelima Denduluri, MD, of Virginia Cancer Specialists in Arlington, Virginia, also said that differentiating drugmediated pneumonitis from pulmonary disease related to the breast cancer itself has been challenging in her experience. She added that having a low threshold to give patients a break from the drug and/or start steroids is important for proactive management.

SYD985 ([vic-]trastuzumab duocarmazine)

Currently in development, SYD985 is an ADC composed of trastuzumab linked to the duocarmycin prodrug seco-duocarmycin-hydroxybenzamide-azaindole orseco-DUBA via a cleavable linker. The trastuzumab moiety binds to HER2 on the cell surface of the tumor, which activates endocytosis and subsequent cleaving of the linker inside the tumor cell by proteases at the valine-citrulline dipeptide and release of duocarmycin (the active moiety). Binding of duocarmycin to the minor groove of DNA followed by alkylation of adenine at the N3 position induces tumor cell death, and the trastuzumab moiety also causes antibody-dependent cell-mediated cytotoxicity in tumor cells with overexpression of HER2.28

An in vitro analysis showed that HER2 3+ and 2+ human cancer cell lines (SK-BR-2 and AK-OV-3, respectively) were sensitive to seco-DUBA, the cytotoxic component of SYD985.29 Additionally, a bystander effect has been reported for SYD985, with killing effects observed in HER2-low and negligible cells, and the cytotoxicity of SYD985 was 7 and 54 times more effective than T-DM1 for HER2/neu 3+ and HER2/neu 1+ cells, respectively (P <.0001).30

Results from a phase 1 expansion cohorts study (NCT02277717) (N = 99) on SYD985 showed an overall response rate of 33% and a median progression-free survival of 9.4 months in patients with HER2-positive breast cancer (n = 50), most of whom had received 3 or more prior HER2-targeting regimens (including T-DM1) for locally advanced or metastatic disease. SYD985 was considered to have a favorable tolerability profile, with fatigue, dry eyes, conjunctivitis, and increased lacrimation as the most common AEs. The most common grade 3 or higher AEs included neutropenia (6%) and conjunctivitis (4%).10

The efficacy and safety profile of SYD985 is also currently being reviewed in the phase 3, randomized, active-controlled TULIP trial (NCT03262935)(estimated enrollment = 345). The study launched in 2017 and is randomly assigning SYD985 or physicians choice of treatment (2:1) to patients with HER2-positive advanced or metastatic breast cancer who had disease progression during or after 2 or more HER2-targeting treatment regimens in the locally advanced or metastatic disease setting. The estimated date of study completion is May 2021.31

ADCs for HER2-Low Breast Cancer

The antitumor activity of trastuzumab deruxtecan and SYD985 in HER2-low expressing breast cancer may confer an advantage over T-DM1 in this subgroup of patients. An analysis of 54 patients with HER2-low expressing advanced breast cancer from the DESTINY-Breast01 trial showed an objective response rate, confirmed by independent central review, of 37.0%, with a median duration of response of 10.4 months, median progression-free survival of 11.1 months, and median overall survival of 29.4 months (95% CI, 12.929.4). These findings prompted the initiation of a phase 3 randomized trial (DESTINY-Breast04; NCT03734029), which will compare the efficacy and safety of trastuzumab deruxtecan with physicians choice of treatment (capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel) in patients with HER2-low expressing, unresectable, and/or metastatic breast cancer.11

In the phase 1 expansion cohorts study (NCT02277717) previously mentioned, SYD985 also showed efficacy in patients with heavily pretreated HER2-low metastatic breast cancer. The overall response rates were 27% among patients with hormone receptor-positive disease and 40% among those with triple-negative breast cancer.10

According to the stakeholders, these ADCs could fill an important niche role in the treatment of HER2-low breast cancer if these findings are confirmed in ongoing and future phase 3 randomized trials. It will be a compelling initiative to have an ADC available for this population and to figure out where to sequence it relative to how we currently treat these patients, said Tan. I would imagine [these therapies would be administered after] theyve progressed on endocrine therapy [when] trying to figure out which potential cytotoxic therapy to use.

Carl Henningson, MD, of Reginal Cancer Care Associates in Englishtown, New Jersey, added that using 1 of the new HER2-directed ADCs after hormone therapy may help address the upregulation of HER2 expression that can occur as a resistance mechanism to hormone therapy. However, Stephen Schleicher, MD, of Tennessee Oncology in Nashville, Tennessee, emphasized improving identification of patients with HER-low expressing breast cancer will also be necessary for determining whether a patient with low expression of HER2 could benefit from HER2-directed therapies. I would imagine so many of our notes say ER/PR positive, HER2-negative, and they dont specify HER2 2+, FISH-negative or HER2 1+, he said. Identifying these patients is an extra roadblock that is different than anything else in breast cancer because clinicians are familiar with HER2-positive so typically think within that framework.

XMT-1522 and ARX788 are 2 of the newest HER2-targeting ADCs currently in early-phase clinical trials for HER2-positive breast and other cancers. XMT-1522 is composed of a novel human IgG1 anti-HER2 monoclonal antibody with Auristatin F-hydroxypropylamide (AF-HPA) as the cytotoxic payload, and a biodegradable polymer conjugation platform is used to achieve an average DAR of 12 AF-HPA molecules to 1 HER2 antibody.32 Initial results from an ongoing phase 1 doseescalation trial (NCT02952729) that included patients with HER2-positive breast, lung, or gastric cancer (N = 19) showed that intravenous administration of XMT-1522 every 3 weeks is generally well-tolerated, with no dose-limiting toxicities or serious AEs attributed to the drug. Disease control (1 partial response and 4 stable disease) was achieved in 5 of 6 patients who received doses of 16 mg/m2 or 21.3 mg/m2, including those who had previously progressed on T-DM1.33

ARX788 is composed of a HER2-targeted antibody site-specifically conjugated to Amberstatin269, a cytotoxic tubulin inhibitor.34 An ongoing 2-part, phase 1 study (NCT03255070) is evaluating ARX788 infused every 3 weeks or every 4 weeks in 6 sequential dose escalation cohorts to determine the recommended phase 2 dose in patients with advanced HER2-positive breast or gastric cancer (estimated enrollment = 60).35

According to the 2020 NCCN guidelines, the preferred regimen for systemic treatment for recurrent or metastatic HER2-positive breast cancer is pertuzumab, trastuzumab, and docetaxel or paclitaxel; other multiple other recommended combinations include HER2-targeted therapy with or without cytotoxic agents.18

The stakeholders discussed how patient factors affect their decision-making in the selection and sequencing of therapies for HER2-positive breast cancer. Clinicians generally use the CLEOPATRA regimen (pertuzumab combined with trastuzumab and docetaxel) in the first-line setting. Hamilton said that for most patients without CNS metastasis, she uses T-DM1 in the second-line setting. For those with CNS metastasis, she usually uses tucatinib plus capecitabine followed by trastuzumab deruxtecan if the patients have normal liver function tests and low to moderate disease burden, and uses trastuzumab deruxtecan if the patients have a large disease burden, including pulmonary symptoms. She noted the difficulty of choosing between the tucatinib regimen and trastuzumab deruxtecan for those with CNS metastasis. I definitely am very impressed with the duration of response and the response rate with trastuzumab deruxtecan, but I also temper that with knowing that they had a median of 6 prior lines, so they were really a more heavily pretreated patient population than the tucatinib patients, she said.

Tan said that she generally prefers to give T-DM1 in the second-line setting and has just begun to incorporate trastuzumab deruxtecan as a third-line treatment in her practice. For patients with brain metastases, she previously used a tyrosine kinase inhibitor such as lapatinib; however, with the compelling tucatinib data, she now prefers a trastuzumabcapecitabine-tucatinib regimen for this patient population. She added that the recent approval of tucatinib introduces the question of whether to obtain an MRI of the brain in patients who are asymptomatic. With the availability of [tucatinib], I am now thinking that if I can get it approved, it might be worthwhile to screen and get that MRI of the brain at the point theyre progressingto then help me decide [whether] to use the tucatinib in that setting, said Tan. Schleicher added that clinicians need to communicate to payors about the importance of brain MRI in asymptomatic patients as it relates to selection of systemic therapy. Imaging is really part of the utilization management strategy, and brain MRI in the asymptomatic breast cancer patient is one of the targets, said Schleicher. We might have trouble doing that routinely depending on how much of our practice is in that space.

Denduluri said that she generally prefers T-DM1 in the second-line setting and may also consider this therapy for patients with an isolated brain metastasis, although she would discuss treatment options with the patient and consider the trastuzumab, capecitabine, and tucatinib regimen as well. For patients with several brain metastases, she would consider the trastuzumab, capecitabine, and tucatinib regimen instead of subjecting them to whole-brain radiation. Although she said that use of trastuzumab deruxtecan in the third-line setting is compelling, the transition from T-DM1 in terms of tolerability can come as a shock to many patients in her experience. I would probably use the tucatinib, cape[citabine] and tucatinib independent of brain mets if they progress on T-DM1 before I would DS-8201, knowing that DS-8201 is so active in a heavily pretreated population, she said.

At the end of the interchange, the stakeholders concluded that new ADCs, particularly trastuzumab deruxtecan and SYD985, could address unmet needs in HER2-positive breast cancer, such as HER2-low expressing disease and CNS metastases. They identified improvement in education about the drug-associated toxicities and further studies about potential roles for ADCs in other settings, such as the adjuvant setting, will be key steps moving forward.

1. SEER cancer stat facts: female breast cancer. National Cancer Institute. Bethesda, MD. March 17, 2020. Accessed July 10, 2020. https://seer.cancer.gov/statfacts/html/breast.html

2. Breast cancer facts & figures 2019-2020. American Cancer Society. Accessed July 10, 2020. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancerfacts-and-figures-2019-2020.pdf

3. Schramm A, De Gregorio N, Widschwendter P, Fink V, Huober J. Targeted therapies in HER2-positive breast cancer - a systematic review. Breast Care (Basel). 2015;10(3):173178. doi:10.1159/000431029

4. Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline focused update. J Clin Oncol. 2018;36(20):2105-2122. doi:10.1200/JCO.2018.77.8738

5. Tarantino P, Hamilton E, Tolaney SM, et al. HER2-low breast cancer: pathological and clinical landscape. J Clin Oncol. 2020;38(17):1951-1962. doi:10.1200/JCO.19.02488

6. Pestalozzi BC, Holmes E, de Azambuja E, et al. CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01). Lancet Oncol. 2013;14(3):244-248. doi:10.1016/S1470-2045(13)70017-2

7. Meric-Bernstam F, Johnson AM, Dumbrava EEI, et al. Advances in HER2-targeted therapy: novel agents and opportunities beyond breast and gastric cancer. Clin Cancer Res. 2019;25(7):2033-2041. doi:10.1158/1078-0432.CCR-18-2275

8. Tukysa. Prescribing information. Seattle Genetics; 2020. Accessed July 16, 2020. https://seagendocs.com/TUKYSA_Full_Ltr_Master.pdf

9. Murthy RK, Loi S, Okines A, et al. Tucatinib, trastuzumab, and capecitabine for HER2-positive metastatic breast cancer. N Engl J Med. 2020;382(7):597609. doi:10.1056/NEJMoa1914609. Published correction appears in N Engl J Med. 2020;382(6):586.

10. Saura C, Thistlethwaite F, Banerji U, et al. A phase I expansion cohorts study of SYD985 in heavily pretreated patients with HER2-positive or HER2-low metastatic breast cancer. J Clin Oncol. 2018;36(supp 15):1014-1014. doi:10.1200/JCO.2018.36.15_suppl.1014

11. Modi S, Park H, Murthy RK, et al. Antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-low-expressing advanced breast cancer: results from a phase Ib study. J Clin Oncol. 2020;38(17):1887-1896. doi:10.1200/JCO.19.02318

12. Jerusalem G, Park YH, Yamashita T, et al. CNS metastases in HER2-positive metastatic breast cancer treated with trastuzumab deruxtecan: DESTINY-Breast01 subgroup analyses. Presented at: 2020 ESMO breast cancer virtual meeting; May 2324, 2020. Abstract 138O.

13. Rinnerthaler G, Gampenrieder SP, Greil R. HER2 directed antibody-drug-conjugates beyond T-DM1 in breast cancer. Int J Mol Sci. 2019;20(5):1115. Published March 5, 2019. doi:10.3390/ijms20051115 Kadclya. Prescribing information. Genetech; 2019. Accessed July 16, 2020. https://www.gene.com/download/pdf/kadcyla_prescribing.pdf

15. Kovtun YV, Audette CA, Ye Y, et al. Antibody-drug conjugates designed to eradicate tumors with homogeneous and heterogeneous expression of the target antigen. Cancer Res. 2006;66(6):3214-3221. doi:10.1158/0008-5472.CAN-05-3973

16. Erickson HK, Park PU, Widdison WC, et al. Antibody-maytansinoid conjugates are activated in targeted cancer cells by lysosomal degradation and linker-dependent intracellular processing. Cancer Res. 2006;66(8):44264433. doi:10.1158/0008-5472.CAN-05-448

17. Lewis Phillips GD, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68(22):9280-9290. doi:10.1158/0008-5472.CAN-08-1776

18. NCCN. Breast cancer. Version 5.2020. Published July 15, 2020. Accessed July 20, 2020. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf

19. Verma S, Miles D, Gianni L. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Eng J Med. 2012;367:1783-1791. doi:10.1056/NEJMoa1209124

20. von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380(7):617. doi:10.1056/NEJMoa1814017

21. Perez EA, Hurvitz SA, Amler LC, et al. Relationship between HER2 expression and efficacy with first-line trastuzumab emtansine compared with trastuzumab plus docetaxel in TDM4450g: a randomized phase II study of patients with previously untreated HER2-positive metastatic breast cancer. Breast Cancer Res. 2014;16(3):R50. doi:10.1186/bcr3661

22. Enhertu. Prescribing information. Daiichi Sankyo; 2019. Accessed July 18, 2020. https://dsi.com/prescribing-information-portlet/getPIContent?productName= Enhertu&inline=true

23. Ogitani Y, Aida T, Hagihara K, et al. DS-8201a, A novel HER2-Targeting ADC with a novel DNA topoisomerase I inhibitor, demonstrates a promising antitumor efficacy with differentiation from T-DM1. Clin Cancer Res. 2016;22(20):50975108. doi:10.1158/1078-0432.CCR-15-2822

24. Ogitani Y, Hagihara K, Oitate M, Naito H, Agatsuma T. Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci. 2016;107(7):10391046. doi:10.1111/cas.12966

25. Tamura K, Tsurutani J, Takahashi S, et al. Trastuzumab deruxtecan (DS-8201a) in patients with advanced HER2-positive breast cancer previously treated with trastuzumab emtansine: a dose-expansion, phase 1 study. Lancet Oncol. 2019;20(6):816-826. doi:10.1016/S1470-2045(19)30097-X. Published correction appears in Lancet Oncol. 2019;(6):e293. doi:10.1016/S1470-2045(19)30292-X

26. Modi S, Saura C, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-positive breast cancer. N Engl J Med. 2020;382(7):610621. doi:10.1056/NEJMoa1914510

27. Powell CA, Camidge DR, Gemma A, et al. Characterization, monitoring, and management of interstitial lung disease in patients with metastatic breast cancer: Analysis of data available from multiple studies of DS-8201a, a HER2-targeted antibody drug conjugate with a topoisomerase I inhibitor payload. Poster presented at San Antonio Breast Cancer Symposium; December 48, 2018; Poster #P6-17-06.

28. ADC Review. SYD985 ([vic-] trastuzumab duocarmazine) drug description. Accessed July 13, 2020. https://www.adcreview.com/syd985-drug-description/

29. Elgersma RC, Coumans RGE, Huijbregts T. Design, synthesis, and evaluation of linker-duocarmycin payloads: toward selection of HER2-targeting antibody-drug conjugate SYD985. Mol Pharm. 2015;12(6):1813-35. doi:10.1021/mp500781a

30. Menderes G, Bonazzoli E, Bellone S, et al. SYD985, a novel duocarmycin-based HER2-targeting antibody-drug conjugate, shows antitumor activity in uterine and ovarian carcinosarcoma with HER2/Neu expression. Clin Cancer Res. 2017;23(19):5836-5845. doi:10.1158/1078-0432.CCR-16-2862

31. SYD985 vs. physicians choice in participants with HER2-positive locally advanced or metastatic breast cancer (TULIP). Clinicaltrials.gov. Updated April 2, 2020. Accessed July 20, 2020. https://clinicaltrials.gov/ct2/show/NCT03262935

32. Yurkovetskiy A, Gumerov D, Ter-Ovanesyan E, et al. Non-clinical pharmacokinetics of XMT-1522, a HER2 targeting auristatin-based antibody drug conjugate [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2017; April 1-5, 2017; Washington, DC. Philadelphia (PA):AACR; Cancer Res. 2017;77(supple 13):abstract nr 48. doi:10.1158/1538-7445.AM2017-48

33. Hamilton EP, Barve MA, Bardia A, et al. Phase 1 dose escalation of XMT-1522, a novel HER2-targetingantibody-drug conjugate (ADC), in patients (pts) with HER2-expressing breast, lung and gastric tumors. J Clin Oncol. 2018;36(suppl 15):2546-2546. doi:10.1200/JCO.2018.36.15_suppl.2546

34. ARX788 HER2 ADConcology. Fact Sheet. Ambrx. Accessed July 13, 2020 ambrx. com/pipeline/arx788-aher2-adc-oncology

35. A dose-escalation study of ARX788, IV administered in subjects with advanced cancers with HER2 expression. Updated June 4, 2020. Accessed July 20, 2020. https://clinicaltrials.gov/ct2/show/NCT03255070?term=NCT03255070&draw=2&rank=1#studydesc

Original post:
Antibody-Drug Conjugates in HER2-Positive Breast Cancer - OncLive

Not all pregnancy tests are made equally. Here are the ones to avoid.

Waiting for the result of a pregnancy test can be the longest few minutes ever. It may be only two or three minutes - but theyll feel eternal. So when youre waiting for those colorful lines to appear or for the screen to show a smiley face, it helps a lot to know that the test is reliable. False positives and negatives are just too nerve-wracking.

It doesnt matter if the test youre using is digital, manual, a strip test or a plastic one, biodegradable or a blood test - all pregnancy tests rely on a single hormone to detect whether or not a woman is pregnant. Theyre all looking for human chorionic gonadotropin (hCG), only found in the body during pregnancy. The sole job of this hormone is to instruct your body not to shed the uterine lining as it would normally do during menstruation - you'll be needing it.

RELATED:This OB-GYN Practice Is Giving Away Free Pregnancy Tests Amid Pandemic

Even though many home testing brands claim to detect hCG as early as a week after conception, its best to wait a bit longer. According to the Mayo Clinic in the early days of pregnancy, the hCG concentration increases rapidly doubling every two to three days. The earlier you take the home pregnancy test, the harder it might be for the test to detect hCG. Waiting is one way to avoid a false positive or false-negative. In other words, its a good way to be sure the test is in fact accurate.

There are dozens of types of home pregnancytests, and it can be very confusing to choose one. There are digital wands that show the words pregnant or not pregnant or a friendly smiley face, but these are more expensive. Or there are simple paper strips - they dont look fancy, but you can buy them in bulk. Some claim to be biodegradable, some claim to tell you in seconds if youre having a baby.

There are a few things to be aware of when administering the test. First, it turns out that there is a wrong way to pee on a stick even though it sounds straightforward. Doing it wrong can raise the chances of a false result, so make sure not to drink too many fluids right before taking the test and to hold it the right way up. That way you can make sure that your urine isnt too diluted and that the sensitive strip will be exposed to enough hCG to detect its presence.

Next, while digital tests are tempting to buy because they lack ambivalence, they arent necessarily more precise and actually take longer to show results. Its true that theres no hemming and hawing about whether something is or isnt a line, but a recent review from The New York Times showed that digital tests can take up to three minutes while strip tests sometimes show the same results in 30 seconds. So for those who want to minimize holding their breath, they might not be the way to go. Digital tests are really just manual tests with a battery and a sensor that reads the lines for you. writes Leigh Krietsch Boerner in her review for the Times.

The Times reviewed ten types of tests and chose the First Response Early Result and Clearblue Rapid Detection as their favorites for their speed, accuracy and comfortable design.

Not very, but enough that you should always confirm a pregnancy with a physician. Its also a good idea to retake a home test a week after to confirm the results.

Ann Gronowski, PhD, is a Professor of Pathology & Immunology and Obstetrics & Gynecology at Washington University in St. Louis who made waves over the past decade for her research into home pregnancy tests. Her research began after a patient who claimed to be pregnant came into an ER with spotting and cramps but tested negative with the regular urine stick that the doctors used. She was certain she was pregnant, so we performed a blood test and an ultrasound, both of which confirmed she was pregnant, Dr. Gronowski told Futurity.

Two papers published by Dr. Gronowski and her collaborators showed that, of the eleven tests they looked at, seven were somewhat susceptible, two were highly susceptible, with two not being susceptible at all to false results. The worst one gave false negatives in 5 percent of the urine samples of pregnant women tested. That was, unfortunately, the test we were using when that initial patient came in, she said.

The scientists working on this could not divulge the names of the specific brands tested, for reasons of liability. However, since the first paper on this topic was published in 2009, the FDA has addressed the issues that the scientists had raised. However, they didnt change the ruling on previously approved, less precise tests, so its still a concern.

NEXT:Condom & Pregnancy Test Sales Have Risen In Canada During Coronavirus Pandemic

Sources:FDA,Futurity,The New York Times,Mayo Clinic

Twins Born At 22 Weeks Defy Odds After Given Zero Chance At Survival

See the article here:
Knowing If A Pregnancy Test Brand Is Unreliable | BabyGaga - BabyGaga

Everyone would like to have thicker hair. Well, almost everyone -- but our focus today is not on those rare unicorns whose complaint is that their hair is just too thick, too luxurious and too lustrous. This article is for the rest of us who would like to have more or thicker hair or at least stop losing what we have.

A number of treatment options have been the staple considerations for normal male and female pattern hair loss for years. For men, finasteride, minoxidil and hair transplantation have long been the most effective interventions. Womens treatment options used to be even more limited, with minoxidil alone being the main option for female pattern hair loss. However, a growing body of research supports that hormone replacement and/or platelet rich plasma injections could be the miracle grow for failing follicles!

First, a note about hormone replacement therapy: A physician named Dr. Glaser published an article in the British Journal of Dermatology in 2012 which made an observation that has unfortunately gained little attention likely because it runs counter to how people usually think about hair loss and testosterone. Dr. Glaser surveyed 285 women who had been on subcutaneous testosterone therapy for more than a year for the treatment of androgen deficiency and 63% of the women who had reported hair thinning prior to treatment reported hair thickening after treatment began. This finding has received little attention, but a 63% response rate deserves further investigation.

Several patients in my own clinic who complained of thinning hair, went on androgen replacement prescribed by their endocrinologist or ob-gyn for other reasons. These patients hair became markedly thicker and more voluminous on testosterone. Although Premier Dermatology does not offer hormone replacement therapy (HRT), androgen levels are one of the laboratory tests that we order as part of our screening panel for causes of hair loss. If we have a female hair loss patient with low androgen levels (either low or low normal), we offer referral to a physician who performs HRT for discussion of risks and benefits of a trial of androgen replacement therapy for hair loss. Results that we have seen have paralleled the 63% response rate that Dr. Glaser published.

Second and just as exciting, Platelet Rich Plasma, also known as PRP, is an option that is fast becoming an important treatment strategy for treating hair loss in both men and women, be it for common hair thinning or for certain alopecia syndromes. PRP is a blood product derived from a patients own blood. The process involves the following: A fraction of blood (up to 22ml in our practice) is drawn from the individual patient into a syringe (depends on the extent of hair loss). This is a relatively small amount compared to blood donation. The blood then is spun in a centrifuge to separate its components (White & Red Blood Cells, Platelet Rich Plasma and Platelet Poor Plasma). The Platelet Rich Plasma (PRP) is collected into a syringe. The PRP is then injected into a treatment area (the scalp for hair loss).

The basis behind PRP is that growth factors and other proteins within platelets promote healing and induce tissue regeneration and rejuvenation. Platelets contain growth factors and biologically active molecules that are normally released when platelets are outside of blood vessels such as when a person gets a cut and starts to bleed into surrounding tissue. Injecting PRP into the subdermal fat induces platelet degranulation (release of platelet contents) which causes tissue exposure to platelet growth factors. In plain terms, PRP delivers growth factors to stimulate hair follicles.

To achieve best results, PRP is performed in a series of treatments. Typically, two to three treatments are performed once per month initially. It is often recommended that treatments take place every 6 months after the initial series of treatments to continue hair regeneration and maintain or enhance results.

PRP has numerous other applications in dermatology the most common of which is as an adjunct to microneedling for skin rejuvenation or treatment of acne scars. However, PRPs greatest potential may be as a treatment to help grow or maintain hair.

At Premier Dermatology and Mohs Surgery of Atlanta, we are committed to offering scientifically-backed, effective and state of the art treatments. Kathryn Filipek, PA-C has extensive cosmetic, surgical and medical dermatology experience and is responsible for the hair loss branch of our practice. If you are interested in exploring PRP and hair loss options, call today to make an appointment with Ms. Filipek. It is our privilege to take care of you and your familys skin, vein, and hair care needs.https://premierdermatologyatlanta.com/

Here is the original post:
Platelet rich plasma and thicker hair | Health Wellness - NorthFulton.com

There are many reasons you can gain weight that have nothing to do with food.

Sometimes weight gain is easy to figure out. If you've changed your eating habits, added more dessert or processed foods, or have been spending more time on the couch than usual, you can typically blame those reasons if you gain a few pounds. But sometimes figuring out why you gained weight is trickier than that.

And while we're living in unprecedented times, whenstress levels are high and activity levels are lower due to quarantine and gym shutdowns, it's normal to gain weight and it's nothing to be ashamed of. But sometimes weight gain is more complicated than that. Weight gain is often caused by more than just the calories you eat and exercise (or lack thereof). The "calories in, calories out" approach is pretty dated when it comes to weight loss, so it makes sense that gaining weight is more complex than that too.

If you've gained weight and are having a hard time pinpointing the cause, keep reading below for five reasons that could be to blame.

Our Health & Wellness newsletter puts the best products, updates and advice in your inbox.

If you're a woman and are dealing with unexplained weight gain, one of the first things you should check out are your hormones. Your hormones regulate so many important processes in your body, including your metabolism.

Hormone issues are pretty complicated though, so you typically need to get lab work done to really understand what's going on. "There are five key hormones that can affect weight and when any of these happen individually or in combination it can trigger fat storage and weight gain," according to Alisa Vitti, a functional nutritionist, hormone health expert and founder of hormone health care companyFLO Living.

Those five hormone issues are:

Several medical conditions that involve hormones can also be to blame for unexpected weight gain.

"When you have a diagnosed condition like PCOS, fibroids, endometriosis, ovarian cysts, PMS -- it means that your body's hormones are not functioning optimally. You could have excess estrogen, you could have elevated cortisol or insulin insufficiency all creating scenarios by which both your cycle as a whole becomes dysfunctional and weight becomes a problem," Vitti says.

"The weight is the symptom of the hormonal imbalance and truly taking care of the hormonal issue is the best way to resolve weight discrepancy," she adds. How you balance hormones depends on your personal situation and health care provider, but generally, it involves lifestyle changes like diet and exercise, and some doctors can prescribe you other things to help like hormone therapy.

Now that you know that hormones are an important part of the weight gain puzzle, you should know how stress can play a role. One of the ways it works? Stress affects hormones, which as we've seen can affect weight, not to mention your sleep too.

"Prolonged low-grade chronic stress is a huge factor for women especially," Vitti says. "Managing invisible domestic work, managing children, working full time, taking care of elderly parents, remembering every detail and managing one's own emotional reaction to current stressful events takes a huge toll on women's adrenals." Your adrenal glands produce the hormones that help regulate your metabolism, blood pressure and immune system, among other things.

The stress of living through a pandemic can cause weight gain.

Stress, and the habits that can result from stress, are part of a bigger picture that Vitti says can all add up to weight gain and inflammation. "Skipping meals, relying on coffee, being depleted of micronutrients from not eating nutrient-dense meals, overexercising, not getting enough sleep, being woken up in the night on a regular basis, working the night shift, being exposed to xenoestrogens in conventional cleaning or beauty products, pesticides in foods, sugar-- [they] can all disrupt these hormones and create a biochemical environment where inflammation and weight gain occur," Vitti says.

"So it's important to understand that because the old model of calorie restriction and increased exercise will absolutely not address all of these underlying factors."

Certain medications can cause weight gain as a side effect.

A common culprit behind unexplained weight gain is medication. Whether you're taking something every day or in the short term, many medications have weight gain as a side effect.

If you're dealing with weight gain and suspect it could be due to a medication you are taking, talk to your doctor to see if there's anything you can do to mitigate the side effects like adjust your dose or maybe switch to a different medication. Some examples of medications that can cause weight gain are antidepressants, diabetes medications and blood pressure medications.

It may be a hard truth to accept but people do usually gain some weight as they age. This happens because as you get older your basal metabolic rate, or the amount of calories your body needs, begins to decline -- and so does muscle mass.

This means you can eat the same and exercise the same at 50 as you did at 30 years old, but not have the same amount of muscle or be able to maintain the same weight. In order to combat this, it's important to adjust your food intake and fitness routine accordingly. For example, focusing on adequate protein intake and strength training can be helpful for maintaining healthy muscle mass as you age.

Failing to get adequate sleep can show up on the scale.

Missing out on quality sleep is one reason why weight gain can creep up on you. When you'resleep deprived, you're probably not that motivated to eat healthy, cook or exercise in the first place. And when you're not getting enough sleep, you're more likely to crave unhealthy foodsand eat more because you feel so exhausted.

Lack of sleep can throw off your hormones, leading to the issues Vitti mentioned above, and it can mess up your appetite signals, which also explains the tendency to overeat when you're tired.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

See the original post:
Quarantine weight gain: 5 reasons that have nothing to do with food - CNET

Amid the pandemic, staying healthy is a top priority for most.

CLEVELAND As the state of Ohio continues it's fight against thecoronavirus pandemic, staying healthy seems to be a top priority for everyone.

But outside of washing your hands, not touching your face and proper social distancing, how can you increase your health and overall wellness? The Cleveland Clinic recommends boosting your immune system.

You diet can have a huge impact on your immune Health.

I believe in the power of immune-boosting foods, says Dr. Darling. Choosing whole, unprocessed foods does wonders for overall health, says Preventive medicine physician and wellness expert Sandra Darling.

She suggests adding foods like garlic, prebiotics, vitamin C-rich foods, and antioxidants to your diet to give your system a boost.

Listen, we know it's hard, but living under constant stress is detrimental to the body. Too much stress "cause causes the body to produce too much cortisol, the stress hormone. Over time, elevated cortisol lowers your resistance to fighting off infection and contributes to poor sleep and higher blood pressure," according to the clinic. Dr. Darling suggests making sure you get enough sleep, exercise and try meditation.

A little bit of positivity goes a long way. "Research shows that positive thoughts reduce stress and inflammation and increase resilience to infection while negative emotions can make you more susceptible to the common cold and flu," according to the Clinic.

If you've done all that you can when it comes to taking care of your immune system health, the Clinic recommends trying supplements and or essential oils.

The Clinic also recommends making sure you're taking time for yourself to rest in recharge. There's a lot going on in the world, you can't pour from an empty cup--so fill yours up!

For more information on the Clinic tips and resources, click here.

Follow this link:
Cleveland Clinic: Four ways to boost your immune health - WKYC.com

Source: Jackie Shepherd / drjessicashepherd.com

Youll be hardpressed to find any area of life that hasnt changed since the onset of COVID-19. And that includes, pregnancy. With the pandemic looming on, with no end in sightparticularly for the United Stateswomen are thinking seriously about family planning, contraception and delaying having children.

Which means birth control.

We spoke to Dr. Jessica Shepherd, practicing OB/GYN and womens health expert at the University of Illinois, about the options available to women these days, specifically the hormone-free IUD called the Paragard, what Black women can do to advocate for a safer, healthier pregnancy and delivery, and what we can do to get the most out of our gynecological visits.

MadameNoire:Have your patients expressed concerns about getting pregnant or giving birth in the midst of this pandemic?

Dr. Jessica Shepherd: I think thats a very valid concern that patients have and should discuss with their doctors. Most pregnancies are unplannedif you want to call it that. But for those who are planning and have those questions, it could require a visit.

MN: In addition to the pandemic, Black women face additional concerns during pregnancy and labor. Do your patients speak to you about these concerns?

Dr. Shepherd: Oh yeah, I think thats the overwhelming topicmore than just this year. But this year has really made it a discussion topic. The increased maternal mortality rate is a public health issue. Its all intertwined but Im glad its being discussed more so we can be very open with our intent on how we plan to fix that.

MN: How is childbirth different because of COVID?

Dr. Shepherd: The process is different in the sense that we cant have more than one person in the delivery room. Many times, if someone is COVID positive, prior to delivery, we have to keep them isolated. And also postpartum if mom is COVID positive, they have to determine the babys status before theyll allow mom to be with baby.

Most hospitals now are testing patients with rapid testing or if they have a c-section or planned induction date, theyll try and test them about a good 48 hours prior to their admission to the hospital. So these protocols are not always easy to implement because deliveries happen any and every time. But its really for the safety of everybody.

Also using PPE wear during delivery, making sure physicians wear eye protection, face shield and the N-95 masks because some people cant get tested before they start the delivery process if theyre already in labor.

The best way to be preventative is to assume that everyones positive.

MN: What do you advice do you offer expectant mothers? Its a public health issue but its not their fault so is there anything you can advise to ensure that theyre able to have a safe pregnancy and delivery?

Dr. Shepherd: There are a few things that Id highlight. If I could name three specific goals that a woman could do it would be:

Not like people dont go prepared but now that we know that this is something to be focused on, its important to go with concise questions. And find a way to document or record the information that you get. If you need to have that information for later, you have access to it. And you can also share that information with someone else so that they know what they heard was exactly as they heard it.

Have a family member, a confidant, a family member, or friend come to visits with them, if thats possible. Because of the pandemic, thats less likely but there are telehealth appointments that can be done. There are consults that can be done with family members around. What we see now because of COVID is bringing people into delivery rooms or appointments via FaceTime so thats a great way that you can have more than one ear open to the information thats being delivered. So you can ensure that more than one person heard it. And that helps to reiterate the messaging.

A lot of times when we give patients information, it can be misconstrued or misunderstood. So one of the ways of navigating through that is having someone there that can reiterate the message and also make sure that it stays prioritized.

Outside of race of the pandemic, I always encourage patients who feel that the relationship they have with their physiciansometimes its not always a physician problem or a patient problem. Sometimes its a communication problem. The communication can be a little off. So thats when you can ask for a second opinion or a different provider or going to another specialist. And you really want to make sure that youre paying attention because one of the things we dont advocate for or dont advise is changing care late in the pregnancy. Thats not helpful to anyone because theres so much time and information that was missed.

And sometimes it can be difficult to determine what needs to be done when you have such a time sensitive process.

Source: Bryan Bedder / Getty

MN: For those people who are trying to avoid getting pregnant during this time, how do you ensure that you dont have a toxic reaction to the birth control that you choose?

Dr. Shepherd: I think one of the things is discussing with your physician prior to having contraceptive counseling is for patients to know whats in what theyre getting.

Now, the great thing about the Paragard is there is no hormone. Its a 100% hormone free. So youre less likely to see what we hear patients referring to when they talk about side effects of contraception. Usually, theyre referring to a hormonal side effect rather than something else. Its usually due to the active ingredient. And the Paragard only has a couple of active ingredients, so if there is an issue we would know what caused it.

MN: Can you tell us more about the Paragard? How is it were able to have birth control with no hormones?

Dr. Shepherd: The Paragard is one of those forms of contraception thats been around for a very long time. Its an IUD. The IUD has been around decades. Its been so longstanding because its reliable. Its hormone free and maintenance is very low. So, once its inserted, its completely reversible. It works for a maximum of two years.

MN: Would you say that women should avoid adding any types of additional hormones to their bodies?

Dr. Shepherd: No, I wouldnt say that. I think when you look at the world of contraception and whats available to womenwhat has been developed over the decades, I think there is absolute need for all forms of contraception, whether they have hormones or not. The availability and the flexibility within our options and choices as women which is the most important.

When you look at how many women are allowed to have that freedom, that should be the take home message.

Yeah, there are going to be a lot of women who dont respond to hormonal birth control but there are millions of women who use contraception, it doesnt matter what kind. And thats the beautiful part about where we are today because prior to contraceptives being developed, women had no options. Like, none. Weve come a long way and I wouldnt label it as something that is not good to have.

MN: What about affordability of birth control?

Dr. Shepherd: When you think about affordability, I usually go to my mainstay of Planned Parenthood. But when you think about contraceptive counseling, people have insurance. They have insurance plans. The most important distinction of whether they go to Planned Parenthood or whether they go to the doctors office is about what am I looking for? What are my expectations? What have I experienced in the past? And using that as a guideline to narrow down your choices of birth control and what looks best for that person. Its a very individual decision.

Most people come in after theyve had an uh oh moment and realize they need to be on birth control. But its really a conversation that should start early in age. Not that they should start at that time but that they have the information. When you have young women who at least know whats available so they can make better decisions for themselves.

MN: When can you do a telehealth appointment and when should you go into your gynecologists office?

Dr. Shepherd:I think thats been something thats changed over the last five months. The telehealth visits can really accomplish more than one would think. I know a lot of people are freaked out like, What?! How are you going to do an exam? Its not so much of the exam but the foundationwith any medical disciplinethe basis of the relationship starts in the information room.

That requires a lot of information that needs to be extracted from the patient, starting the discussion. When you look at it from that perspective, you can start the discussion and determine if its something thats urgent and the patient needs to come in right away or two weeks out or maybe they can get their question resolved right then.

In my practice, the top three things I saw patients for on telehealth were abnormal uterine bleeding, contraceptive counseling, and IUDS. So we would do the initial consultation and then bring them in for the insertion.

I saw an increase in IUD patients over this time because people were thinking about things that were longstanding so the features of the IUDS really made a stand out appearance because it has such low maintenance

MN: How can women make sure they get the most out of their gynecological visits? Too often we go into those appointments anxious or scared and then we end up leaving without giving or receiving the information we wanted.

Dr. Shepherd: One of the best features is to come prepared. We all have it in our heads, right and then you get there and then you have some anxiety and then you leave and youre like, I literally forgot to ask A, B, and C. So writing it down is sometimes the best and easiest advice to take.

Now, I would say the challenge is when patients have the expectation that the questions they bring are all going to be answered. That sometimes can fail.

The relationship between a physician and patient should be one thats ongoing. So the expectation of going and getting twenty questions answered versus we can look at those questions and say lets tackle the most important ones that are impacting you right now and then lets do a follow up visit and get to the rest of those questions. Sometimes its a part B and part C type of visit.

Read the original post:
Dr. Jessica Shepherd Talks Family Planning During COVID And Getting The Most Out Of Your Gyno Visits - MadameNoire

Janelle Ayres, a physiologist specializing in infectious diseases at the Salk Institute for Biological Studies, describes this concept as a disease tolerance mechanism the ability, sometimes hard-wired, sometimes induced by environmental factors, to survive infections without falling ill. Our traditional view has been: To survive an infection, you have to kill it, she told me. We have a very disease-centric approach to biology. But infection doesnt always equate to disease. Many of the most frightening pathogens tuberculosis, cholera, polio and now the coronavirus dont cause illness in everyone they infect. Some people experience these infections with few if any symptoms. Their immune systems evidently handle the invasion with the perfect balance of aggression, restraint and repair or tolerance to stave off disease. The drugs of the future, Ayres hopes, will enable these native tolerance mechanisms that help some shrug off, with few ill effects, the diseases that sicken and kill others.

The Covid-19 pandemic has already prompted many physicians to bend in this direction. So few tools exist to reliably eliminate the virus from our bodies that they have, out of necessity, turned to the idea of prodding the immune system in various ways. They have shifted their focus in a manner that Ayres has long argued is necessary: from eradicating the pathogen to helping the patient survive the pathogen. They are, in a way, pinning their hopes on innate tolerance mechanisms.

Dozens of trials are currently underway that focus on the immune system. These involve everything from cheap, over-the-counter pain medication to expensive antibodies manufactured in living cells. The drugs they are testing include anakinra, used by Navarro-Milln; leronlimab, a drug with anti-inflammatory properties originally developed to treat H.I.V.; and drugs that block IL-6 (full disclosure: My wife works for Genentech, owned by Roche, which manufactures tocilizumab, one of the IL-6 blockers). One study in Britain is testing high doses of a stomach-friendly formulation of the nonsteroidal anti-inflammatory ibuprofen, better known in the United States as Advil. (Dont try this at home.) Researchers are even looking into low-dose X-ray radiation as a way to calm the immune system, a method that was used in the early 20th century to treat pneumonia but has since fallen out of use.

Theres an intriguing trial on an old drug originally developed to treat gout, a painful inflammatory condition of the joints, called colchicine. The drug, which was recently shown to offer protection against heart attacks, targets the very pathway called NLRP3 inflammasome that some scientists believe is naturally dampened in bats. Unlike biologics, which are given intravenously, colchicine can be taken in pill form. And while biologics can cost hundreds of dollars per dose, colchicine is dirt cheap. We think that in the setting of this viral infection, NLRP3 gets activated aberrantly, says Priscilla Hsue, a professor of medicine at U.C.S.F. and one of the physicians overseeing the trials. And that leads to downstream badness. The drug, its hoped, will prevent the immune system from ever getting to the point where it becomes overly activated. The study aims to start treatment early by sending pills to the homes of patients who have tested positive for Covid-19. The thought is, If we can intervene early with an anti-inflammatory agent, we can have an impact on slowing down progression and keeping patients off ventilators, Hsue says.

It remains to be seen which, if any, drug will work best, and what might be the unforeseen consequences of suppressing the immune system in the midst of its battle with the coronavirus. Some trials are already showing failures. Despite promising results from early, weak studies, two of the strongest trials to date on the IL-6 blockers tocilizumab and sarilumab suggest no benefit. (The pharmaceutical companies running the studies, Roche and Regeneron, are continuing with other trials testing their IL-6 blockers.)

Or maybe the studies would have produced better results had they been designed differently. Thomas Yadegar, who thinks tocilizumab can be a lifesaver, if used in the right way, surmises that one study didnt employ stringent-enough criteria for choosing its study patients. Navarro-Milln thinks the trials tried to treat patients too late in the course of the disease. She likened these efforts to trying to cure Stage 4 metastatic cancer probably doomed from the start.

Other researchers also raise this issue of timing when doctors should administer drugs to curb immune responses in a more general sense. Suppressing the immune system too soon after infection could be counterproductive because it might squelch the initial antiviral response and allow the coronavirus to proliferate, says Dawn Wahezi, a pediatric rheumatologist at Childrens Hospital at Montefiore. Yet treating too late may make it impossible to quell the eventual immune overreaction. Knowing when is the right time I think thats one of the key components, Wahezi told me. Theres a very delicate window where immunomodulators can help.

Visit link:
How Covid Sends Some Bodies to War With Themselves - The New York Times

For Adam Winney, a 26-year old with Type 1 diabetes, grocery shopping during the early days of a pandemic was an infuriating task. Everything was sold out, except for the one type of food he couldnt eat.

The only things left were carbs, carbs, carbs, the Van Nuys resident said. Ive never been more furious than back in March.

For the record:

1:54 PM, Aug. 11, 2020A previous version of this story said an insulin pump delivers insulin to the pancreas of a person with Type 1 diabetes. The pump actually infuses the insulin under the skin so it can be absorbed into the bloodstream.

Winneys disease has deprived his body of insulin, a hormone thats needed to turn the sugar in carbohydrates into energy. Without it, his blood sugar can spike to dangerous levels, eventually leading to serious health problems like cardiovascular disease, nerve damage and kidney failure.

But the insulin pens he relies on to keep his body in balance cost him upwards of $1,000 a month, since his health insurance doesnt cover the medication. After the coronavirus outbreak cost him his job as a receptionist at a hair salon, that expense was beyond his reach. He went six weeks without the long-acting insulin he usually takes every day.

I was fighting nausea every morning, he said, a sign that his body was susceptible to diabetic ketoacidosis, a state of dangerously high blood sugar levels that has landed him in the hospital before. Your body just falls apart.

Newsletter

Get our free Coronavirus Today newsletter

Sign up for the latest news, best stories and what they mean for you, plus answers to your questions.

Enter Email Address

Sign Me Up

You may occasionally receive promotional content from the Los Angeles Times.

COVID-19 presents a unique set of challenges to the roughly 34 million Americans like Winney who are living with diabetes.

The Centers for Disease Control and Prevention says people with Type 1 diabetes are probably more susceptible to a severe case of COVID-19. Those with Type 2 diabetes the more common form that begins when people lose their sensitivity to insulin are definitely at increased risk of severe COVID-19, according to the CDC.

For instance, a study of more than 7,300 COVID-19 patients in China found that those with Type 2 diabetes needed more medical care and were nearly 50% more likely to die than patients without diabetes. The risk of death was especially high for people who had trouble controlling their blood sugar, researchers reported. Another study of more than 1,200 COVID-19 patients in the U.S. found that the mortality rate for those with diabetes or high blood sugar was 29%, compared with 6% for those without diabetes.

The extent to which you control your diabetes is a risk factor, said Dr. Daniel Drucker, a senior scientist at the Lunenfeld-Tanenbaum Research Institute at the University of Toronto. Theres a lot we can do about that, by making sure that your diabetes is optimally controlled.

Insulin is essential for keeping blood sugar in check, but the pricey medicine is harder to get if a job disappears, along with the health insurance that came with it.

The cost of insulin varies from patient to patient. It depends on the type of insulin they need some take effect within 15 minutes; others last more than a day as well as the dose. Some insurance plans pick up more of the tab than others.

The financial strain brought on by the pandemic has forced Royce Jonathan Miller of Yuba City to consider rationing the insulin he takes for Type 1 diabetes. He has kept his job as an optician at Walmart, but since his father-in-law lost his job at a maintenance company that closed operations due to the pandemic, Miller has become the sole provider for the four people in his household.

Brandi DaVeiga programs the insulin pump that helps her control her Type 1 diabetes.

(Christina House / Los Angeles Times)

Miller has an insulin pump, which uses a tube to infuse a small amount of insulin under the skin so it can be absorbed into the bloodstream. He is supposed to change out the pieces that connect to his body every three days. Lately, hes been wondering if thats absolutely necessary.

Im starting to think, I can stretch that up for two cycles, every six days, and hopefully it doesnt get infected, Miller said. But I do realize that if I am to make myself sick and wind up in the hospital, that will be a bigger burden.

A nationwide survey of 5,000 people with diabetes conducted for the American Diabetes Assn. found that one in four have rationed supplies to cut the cost of their diabetes care since the start of the pandemic.

Now is not the time to let up on helping these individuals manage their disease, because it may in fact be helpful in preventing them from getting severe COVID-19, Drucker said.

People with Type 2 diabetes may face even greater hardship in affording their insulin, said Dr. Francisco Prieto, a family health physician in Sacramento.

Not everyone who has Type 2 has to take insulin, Prieto said. Those who do are typically folks who either have the most severe cases of diabetes or have failed all the previous oral and injectable treatments. That means they may need to take even more insulin on a daily basis than Type 1 patients, he said.

Since 2019, 11 states have set limits on the amount insurance companies can set as co-payments for insulin. Each of those states has enacted price caps ranging from $25 to $100 per month since the coronavirus outbreak took off in March.

California may soon join the list. In February, Assemblyman Adrin Nazarian (D-North Hollywood) introduced a bill that would cap insulin co-pays at $50 for a 30-day supply, or $100 per month. It passed in June by a 64-4-11 vote, but the Senate Health Committee has not scheduled a hearing that would allow the bill to move forward.

Winney said a price cap would give him some peace of mind. These days he relies on free samples provided by one of his doctors, but that generosity may not last.

I see that as an incentive to finally change insurance, he said.

Brandi DaVeiga, who has Type 1 diabetes, at home in Lakewood.

(Christina House / Los Angeles Times)

Ensuring an affordable supply of insulin would help people with diabetes manage their disease better, said Brandi DaVeiga, a stay-at-home mom in Lakewood with Type 1 diabetes. She has good coverage now through her husbands health insurance plan, but when she was between plans three years ago, she began skipping insulin doses to make her supply last longer. On several occasions, her blood sugar levels rose dangerously high, and she ended up in the emergency room.

Its really stressful, she said of managing diabetes during a pandemic. And that doesnt help your blood sugar.

The fact that people with diabetes are rationing their insulin when they need it most points to larger problems with healthcare access in this country, Drucker said.

COVID-19 is reminding us of the importance of doing everything we can in our vulnerable, at-risk populations, he said. Lets do everything we can to optimize their health because that may, in turn, reduce their risk of having a bad outcome with this virus.

Follow this link:
Amid COVID-19, people with diabetes struggle to get insulin - Los Angeles Times

No matter what type of diabetes you have, the goal of diabetes treatment is to control blood sugars and keep them within the healthy range.

Type 1 diabetes must be treated with insulin, since the pancreas does not produce insulin naturally. People with type 2 or gestational diabetes don't always need insulin treatment, and will often focus on lifestyle changes and oral medications that encourage insulin production or decrease insulin resistance.

With proper access to healthcare, diabetes is highly treatable, says Katherine Araque, MD, an endocrinologist and director of endocrinology of the Pacific Neuroscience Institute at Providence Saint John's Health Center in Santa Monica, California.

Here are the four main ways you can treat and manage your diabetes.

Insulin is a hormone produced in the pancreas in healthy individuals. It helps facilitate the process of converting blood sugar into fuel, so that glucose doesn't build up in the blood.

In people with type 1 diabetes, the pancreas cannot produce insulin, so they need synthetic insulin. This can happen in two ways:

People with type 2 diabetes are treated with insulin when they are unable to control their blood glucose levels with lifestyle changes and medication. Overall, roughly 24% of people with diabetes are treated with insulin, according to a 2018 study published in Diabetes Care.

If you need insulin, your doctor will provide specific guidance on how much you need and when you should take it.

Although people with type 1 diabetes will need insulin, they may also be prescribed medication if they have some remaining pancreas function. The medication can encourage insulin production in the body.

People with type 2 diabetes are prescribed medication when they can't control their blood sugars through diet and exercise. Oftentimes, people with type 2 diabetes use more than one medication to control their condition.

However, medications are usually not recommended for pregnant people with gestational diabetes.

Common medications used to treat diabetes include:

Metformin is the most common medication used to treat type 2 diabetes. It's sometimes used to treat type 1 diabetes in people who still have some insulin production, along with insulin.

Metformin helps control blood sugar by making it easier for the body to absorb glucose. It's usually taken twice a day, with meals. Even when used alone, metformin can reduce A1C levels by 1.5% on average, which is enough to drop blood sugar levels from diabetes to prediabetes.

Sulfonylureas are a class of drugs that encourage the pancreas to release more insulin. They're used to treat type 2 diabetes. They are often taken once or twice a day before meals.

Sulfonylureas have a similar efficacy to metformin, and can be used alongside it.

TZDs make it easier for the body to use insulin; they reduce insulin resistance. They can be used to treat type 2 diabetes. They are taken 1 to 2 times per day.

After a year of taking TZDs, people with type 2 diabetes reduced their A1C levels by 1.4%, according to a 2019 study published in Vascular Health Risk Management.

Exercise is important for people with all types of diabetes. "Exercise helps at multiple levels: it increases base metabolic rate, fights insulin resistance, and helps with weight loss," says Araque.

Exercise helps muscles burn glucose and reduces insulin resistance. When you exercise, your muscles burn more glucose, removing it from the bloodstream and helping to lower blood sugar levels.

For example, a 2017 study published in Biomedical Research followed 120 obese teens, who did two hours of aerobic exercise twice a day for six days a week. After five weeks, their average fasting blood sugar was reduced by 0.84 nanomoles per liter (nmol/L) for males and 1.04 nmol/L for females. The researchers described this as "an extremely significant difference."

The Center for Disease Control and Prevention (CDC) recommends that people with diabetes get the normally recommended amount of exercise: 150 minutes of exercise each week, including two days of strength workouts that incorporate major muscle groups. The American Diabetes Association recommends starting with small changes, like walking daily.

Any exercise will help, but some may be especially beneficial. For example, a 2019 study published in Diabetologia found that afternoon exercise decreased blood sugars more than morning exercise.

Overall, you should work with your doctor to identify an exercise program that will benefit you, Araque says.

Healthy eating is critical for people with diabetes. As food breaks down, it releases glucose into your blood. Some foods, including processed sugars and carbohydrates, raise blood sugars more than other foods, like proteins or leafy vegetables.

In particular, people with diabetes need to be aware of how many carbs they eat per day. They should also create an eating plan that includes the following:

For example, the DASH diet and Mediterranean diet which both emphasize healthy fats, lean protein, protein and vegetables have been proven to help people with type 1 and type 2 diabetes control blood sugar.

Read more about the best ways to eat if you have diabetes:

Diabetes is a chronic but manageable condition, Araque says. People with diabetes should work with their doctor, nutritionist, and an exercise professional to design a program that meets their needs.

"The most important message is if they follow these recommendations they can get this under control and decrease risk for complications," Araque says. "Patients should have hope."

Originally posted here:
4 of the best ways to treat diabetes and lower blood sugar - Insider - INSIDER

Newtown Aug 13, 2020 (Thomson StreetEvents) -- Edited Transcript of Onconova Therapeutics Inc earnings conference call or presentation Wednesday, August 12, 2020 at 8:30:00pm GMT

* Abraham N. Oler

Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel

Onconova Therapeutics, Inc. - CFO

Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development

* Steven M. Fruchtman

Onconova Therapeutics, Inc. - CEO, President & Director

Laidlaw & Company (UK) Ltd., Research Division - MD of Healthcare Research & Senior Biotechnology Analyst

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Good afternoon, and welcome to Onconova Therapeutics corporate update and 2Q 2020 financial results conference Call. (Operator Instructions) As a reminder, this call may be recorded. At this time, I would like to turn the call over to Avi Oler, Senior Vice President of Corporate Development and General Counsel.

Abraham N. Oler, Onconova Therapeutics, Inc. - Senior VP of Corporate Development & General Counsel [2]

Thank you, operator. Good afternoon, and welcome to Onconova's second quarter 2020 corporate update and financial results conference call. Earlier this afternoon, we issued a press release outlining our financial results and business progress during the quarter. If you have not seen this press release, it is available on the Investor Relations page of our website at http://www.onconova.com. On today's call, Dr. Steve Fruchtman, President and CEO, will discuss the company's recent highlights and anticipated clinical and business milestones. After Steve completes his opening remarks, Mark Guerin, our Chief Financial Officer, will review second quarter financial results. Following Mark's report, we will move to the Q&A portion of the call, which will be joined by Dr. Rick Woodman, our Chief Medical Officer. Lastly, Steve will come back with some final comments and a review of our upcoming milestones.

Before we begin, I remind everyone that statements made today during this conference call will include forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which involve risk and uncertainties that can cause actual results to differ materially. Forward-looking statements speak only as of the date they are made, as the underlying facts and circumstances may change. Except as required by law, Onconova disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. Please see the forward-looking statements disclaimer in the press release issued this afternoon and the risk factors in the company's current and future filings with the SEC.

With that, it is now my pleasure to turn the call over to Steve.

Thank you, Avi. Good afternoon, everyone, and thank you for joining today's call. First, as the COVID pandemic continues to evolve in the U.S. and abroad, we wish all safety and good health to you and your love ones. We remain committed to executing our goals with INSPIRE and beyond. We remain focused on INSPIRE data readout and we'll speak more about the COVID pandemic shortly. Onconova has had a productive second quarter and exited the quarter carrying a significant momentum into the second half of 2020. As previously indicated, our pivotal Phase III INSPIRE trial recently achieved required number of survival events to allow for data analysis, and we anticipate top line data readout by the end of September. COVID has made access to hospitals and clinics more difficult, so data verification of key dates such as survival and the most recent clinical encounters are more difficult to verify, but verify, we must and we shall. Following top line data readout, we expect to present more detailed data at a major medical meeting later this year. The meeting to be identified based on time lines. Of note, most, if not all, major medical meetings are now virtual. To shorten the time lines for our anticipated new drug application or NDA submission to the FDA, we have already begun NDA preparation prior to data readout. We are working also with regulatory consultancy experts on our NDA document for the U.S. FDA for both the clinical and manufacturing modules of the NDA as well as on the marketing authorization application, or MAA, document for the European Medicines Agency. We anticipate that this initial work will put us in a position to expedite our health authority applications when data becomes available. As part of this process, our clinical team under Rick Woodman's leadership is preparing for a pediatric investigational plan, or PIP, an important component of the MAA. We are also advancing our plans to be ready for commercialization, including the recent announcement of the election of a commercial expert, Ms. Terri Shoemaker, to our Board of Directors. Terri carry was instrumental in the successful commercialization of azacitidine, the most commonly used hypomethyl agent in the world for high-risk MDS.

As you recall, INSPIRE is an open-label, randomized, controlled, international study designed to determine the efficacy, safety and tolerability of single agent intravenous rigosertib in the treatment of patients with second-line, high-risk MDS. Patients in this study are less than 82 years of age and have progressed or relapsed or failed to respond to previous treatment with the standard of care, a hypomethylating agent, also called an HMA. The study randomized patients to receive either rigosertib with best support of care or the physician's choice of therapy with support of care. The primary endpoint of this study is overall survival of all randomized patients in the intent-to-treat population. There is a second opportunity for an FDA approval, which is the sequential analysis of the overall survival of the very high-risk MDS subs as defined by the revised International Prognostic Scoring System. Should intravenous rigosertib demonstrate a survival advantage compared to physician's choice of therapy on the INSPIRE trial in a statistically significant manner, we believe rigosertib could be a major advance for high-risk, second-line MDS patients with a novel mechanism of action. Hopefully, broader and additional novel indications will follow.

Beyond our progress with INSPIRE, a highlight of the quarter was the initiation of an investigator-initiated Phase I/II trial of oral rigosertib plus the immune checkpoint inhibitor, nivolumab, in advanced metastatic KRAS positive lung adenocarcinoma. Over half of non-small cell lung cancers are classified at lung adenocarcinoma. And of these, the largest subset has a KRAS mutation as the predominant genetic driver. Given their utility in multiple cancer setting, checkpoint inhibitors are among the world's top-selling pharmaceutical products. And continue to obtain FDA approval for broader indications. In our view, this makes our novel combination approach with rigosertib a potentially meaningful option to pursue in lung cancer. We hope this will offer patients who have progressed on first-line therapy, a second-line approach. We are also initiating studies in other RAF pathway-driven cancers as part of our investigator-initiated development program.

Onconova has also recently featured pipeline developments in multiple venues. At the European Hematology Association's virtual conference in June, we announced updated aggregated baseline genomic data for HMA failure patients screened and entered into the INSPIRE trial. Briefly, the presentation show that RAF pathway mutations in these higher-risk MDS patients were observed more frequently in patients who progressed on HMA therapy as defined by the international working group's definition of progression compared to those who failed to respond to HMA therapy. In fact, in this study, patients with mutations of the RAF pathway had a higher likelihood of progression on hypomethylating agents than those with TP53 mutations, a well-recognized genomic abnormality predicting for progression in a number of cancers. We believe this is informative to the potential role of RAF targeting agents such as rigosertib. And to our knowledge, this mutational analysis is among the largest such databases to be collected. Patients on the rigosertib and physician's choice arms will have repeat analysis of their genomic status performed as part of the INSPIRE trial.

Following the close of the second quarter, Onconova also announced a publication of Phase I data with the combination of oral rigosertib plus azacitidine and higher-risk MDS and AML in the journal, Leukemia Research. A key strategy emerging in the treatment of MDS is the identification of safe and effective combination, particularly those involving oral agents. We anticipate meeting with the FDA in conjunction with the pivotal data readout from the INSPIRE trial for alignment with the agency on a registration trial for the combination of oral rigosertib plus azacytidine and HMA-naive, high-risk MDS. We look forward to these interactions with the agency. In the journal, Molecular Cell, we also announced the publication of additional preclinical data, supporting rigosertib's mechanism of action as a RAS-targeted anticancer therapy. Onconova believes this data sheds light on the ability of rigosertib to modulate the RAS pathway.

We also disclosed that we have embarked on early preclinical work exploring legal service potential in COVID-19. The background for this is as follows: these preclinical studies follow a presentation at ASH in 2019, suggesting the ability of rigosertib to upregulate viral defense pathways such as interferon. It is hypothesized that the immune system may play a role in the pathogenesis of MDS and immune modulation has been studied in MDS. More recent preclinical studies conducted with rigosertib demonstrated impressive inhibition of SARS-CoV-2 replication in vero cells when compared to controls, and provide the company with optimism that further research in humans infected with SARS-CoV-2 is warranted. In late July, Onconova announced that it has applied to the National Institute of Allergy and Infectious Diseases, or NIAID; and also to BARDA, the Biomed Advanced Research and Development Authority, to seek funding and to participate in therapeutic trials under the NIH umbrella to conduct human studies with rigosertib. We caution that our work in COVID-19 is very early, and the need for therapeutics and effective vaccines is evolving rapidly as the pandemic continues in various geographies across the globe. Hence, we cannot predict what the outcome of our efforts will be. We hope to provide greater clarity sometime during the second half of this year. In addition to the U.S., we have the rights to rigosertib in Europe and China and other key markets around the world. Beyond rigosertib, ON 13300 (sic) [ON 123300] is our first-in-class inhibitor of CDK4/6 and ARK5. We believe ON 123300 has the potential to treat numerous cancers, including refractory metastatic breast cancer, where CDK4/6 inhibitors are already commercially available. CDK inhibitors have emerged as promising products and compounds targeting very large cancer indications such as hormone receptor positive metastatic breast cancer. Due to its unique targeting of ARK5 as well as CDK4 and 6, we believe ON123300 could overcome many of the existing product's limitations, potentially making it suitable for certain cancers that may not be responsible -- responsive, sorry, to the current generation of CDK4/6 inhibitors. If successful, we believe this product candidate could address this very large market opportunity. We maintain global rights for ON 123300 outside of China. Our partner in China for this compound is HanX Biopharmaceuticals. HanX funded the Chinese IND-enabling studies. The Chinese IND was approved in January 2020 by the Chinese health authorities. We anticipate a Phase I study may begin in China in the second half of 2020. We also intend for the Chinese IND-enabling studies to comply with FDA regulations. To the U.S., we plan to file a U.S. IND in the fourth quarter of 2020.

And now I'd like to turn the call over to Mark Guerin, our Chief Financial Officer, for a discussion of our financial results for second quarter 2020. Mark?

--------------------------------------------------------------------------------

Mark Patrick Guerin, Onconova Therapeutics, Inc. - CFO [4]

--------------------------------------------------------------------------------

Thanks, Steve, and good afternoon, everyone. First, as a reminder, early this month, Onconova received a letter from NASDAQ stock market stating that it had regained compliance with the minimum bid price requirement of the NASDAQ listing rule 555-082 because its common stock had a minimum closing price of at least $1 per share for a minimum of 10 consecutive business days.

Our cash and cash equivalents as of June 30, 2020, totaled $27.2 million compared to $22.7 million as of December 31, 2019. Common stock warrant exercises since our financing transactions in November and December 2019 have added $9.8 million to our balance sheet since January 1, 2020. And as of August 12, 2020, we have 183,568,267 common shares outstanding. Additionally, of the almost -- of the warrants outstanding as of June 30, 2020, over 80% of them were in the money as of August 12. Based on our current projections, we expect that our cash and equivalents will be sufficient to fund ongoing trials and operations into the fourth quarter of 2021. Our net loss was $7.4 million for the quarter ended June 30, 2020, compared to $3.6 million for the comparable period in 2019. Research and development expenses were $4.8 million for the quarter ended June 30, 2020, and $3.9 million for the comparable period in 2019. General and administrative expenses were $2.6 million for the quarter ended June 30, 2020, and $1.8 million for the comparable period in 2019. Our operating cash burn in the second quarter of 2020 was approximately $5.4 million. This completes my financial review.

I'll now turn the call back to Steve.

--------------------------------------------------------------------------------

Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [5]

--------------------------------------------------------------------------------

Thank you so much, Mark. With that, we'd like to open the call for questions. After the questions and answers, I'll finish with some closing comments. Operator, please open the Q&A session.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question comes from the line of Joe Pantginis from H.C. Wainwright.

--------------------------------------------------------------------------------

Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [2]

--------------------------------------------------------------------------------

First, I'd like to ask about your initial comments about the data verification process for the study. What do you think are the real rate-limiting steps now, either COVID related or unrelated? And then secondly, with that, I think this is more of a what-if question, do you have any visibility now with regard to any potential patients lost due to COVID that might impact the statistics? And have you had any discussions with the FDA about this and they have put out a recent public guidance a couple of months ago about being a little more amenable to adjusting statistical plans due to COVID.

--------------------------------------------------------------------------------

Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [3]

--------------------------------------------------------------------------------

Joe, thanks for that question, and I'll ask Rick to please provide the answers.

--------------------------------------------------------------------------------

Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [4]

--------------------------------------------------------------------------------

Thank you, Steve, and thank you, Joe. So all along, the biggest challenge that we observed with our study related to COVID was access to documents and -- at the sites. And this is not necessarily physically being able to get to sites, but even having remote monitoring opportunities. We have been able to overcome almost all of those difficulties and challenges. Now we are still in database lock, and so we are continuing to clean data and monitor and source data verify. But to date, it's gone very well. And I think it's in part, the understanding by the sites regarding where we are in the life cycle of the study and the importance of this data to the outcome of the study and to this disease. We have not lost any patients due to COVID at this time. The commonest challenge we see is that patients are -- have symptoms suggestive of COVID and then undergo testing and then report to us the results, negative or positive.

--------------------------------------------------------------------------------

Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [5]

--------------------------------------------------------------------------------

Got it. And as things continually get more exciting for you guys coming into the data, I guess I'll ask the question at this point, again, and I know I do ask this a lot about what you feel is outstanding with regard to the oral study ahead of your upcoming FDA meeting?

--------------------------------------------------------------------------------

Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [6]

--------------------------------------------------------------------------------

Well, I think the primary challenges are related to the unique adaptive design we're proposing to the FDA and that will require some discussion between us and the agency. I think that the timing of INSPIRE, if positive, could very much support their interest in an adaptive study design that has an expedient execution and conduct with oral rigosertib.

--------------------------------------------------------------------------------

Joseph Pantginis, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [7]

--------------------------------------------------------------------------------

Good luck for this major thing coming up for you guys. Real exciting.

--------------------------------------------------------------------------------

Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [8]

--------------------------------------------------------------------------------

Thank you.

--------------------------------------------------------------------------------

Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [9]

--------------------------------------------------------------------------------

Thank you, Joe.

--------------------------------------------------------------------------------

Operator [10]

--------------------------------------------------------------------------------

Our next question comes from the line of Naureen Quibria from Maxim Group.

--------------------------------------------------------------------------------

Naureen Quibria, Maxim Group LLC, Research Division - Senior Equity Research Associate [11]

--------------------------------------------------------------------------------

Steven, congrats on the quarter. So I guess I want to start off with the KRAS study that's going on right now, obviously. So I was just wondering, it's an open-label study, do you have any idea if we'll have any updates this year on that? And then what kind of response rates would you -- would give you some confidence in terms of you feel there's activity in this tumor type? I know it's a long ways away, but I'm curious about that as well.

--------------------------------------------------------------------------------

Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [12]

--------------------------------------------------------------------------------

So thank you. And I just want to point out that this is a Phase I study, and I'll ask Rick to give -- offer the more details that we may have.

--------------------------------------------------------------------------------

Richard Charles Woodman, Onconova Therapeutics, Inc. - Chief Medical Officer and Senior VP of Research & Development [13]

--------------------------------------------------------------------------------

Thank you, Steve. So we're in the early phases of enrollment with this study. I think, obviously, with these studies, data can become available sooner than anticipated. Or conversely, take much longer than anticipated depending upon dosing and development DLTs. Because this is a Phase I study, Steve mentioned safety, DLT determination and determination of a recommended Phase II dose for the combination is the priority. I think like all Phase I studies, we are always excited about responses, but that is not what's going to determine the success of the study or the ability to proceed with other studies. It will be dosing and safety.

--------------------------------------------------------------------------------

Naureen Quibria, Maxim Group LLC, Research Division - Senior Equity Research Associate [14]

--------------------------------------------------------------------------------

Sure. That's helpful, actually. And then in terms of moving oral or looking at oral rigosertib in COVID, and you mentioned that you'd applied for a grant. I was just wondering what's the turnaround time for that. And, a, when will you know anything? And then in terms of the economics, is this just -- would it be sufficient for IND-enabling studies or actually for a clinical trial?

--------------------------------------------------------------------------------

Steven M. Fruchtman, Onconova Therapeutics, Inc. - CEO, President & Director [15]

--------------------------------------------------------------------------------

So I'll take that and thank you. So you mentioned oral rigosertib. So why we believe rigosertib should be studied in COVID disease is because we have oral and intravenous rigosertib. So as you know, there's different levels of disease with COVID infections, some relatively mild and some pent demand to pulmonary [cell]. So based on the inhibition of SARS-CoV-2 in cell culture systems. As you mentioned, we've applied for funding through the NIH federal mechanism of studying COVID disease. Early in the disease, ideally, it would be with oral rigosertib to see if it would prevent progression to pulmonary insufficiency for patients who have already reached, unfortunately, the stage of pulmonary insufficiency, requiring ventilatory support, that would be a group of patients who could be studied with intravenous rigosertib. Because the global pandemic is changing rapidly, it is unclear to us how NIH and the federal funding agencies will make decisions regarding both therapeutics and vaccines. We believe as long as the pandemic continues to rage, there is a great need for the development of additional efficacious therapeutics. So thus, we believe, based on the preclinical studies, we would like to participate in any clinical trials that the NIH may be considering for therapeutics. But clearly, the NIH is appropriately focused on the development of vaccines, and thus, it's unclear to us where NIH stands on the issue in question of the role of therapeutics during the pandemic and the role of vaccines. Any information we have going forward, we will be happy to share that with the investment community.

--------------------------------------------------------------------------------

Operator [16]

--------------------------------------------------------------------------------

Our next question comes from the line of Ahu Demir from NOBLE Capital.

--------------------------------------------------------------------------------

Ahu Demir, NOBLE Capital Markets, Inc., Research Division - Biotechnology Research Analyst [17]

--------------------------------------------------------------------------------

View post:
Edited Transcript of ONTX.OQ earnings conference call or presentation 12-Aug-20 8:30pm GMT - Yahoo Finance

Building muscle is a slow but worthwhile process.

Many people start workout routines to look toned or lean. Lifting weights can help you achieve those goals, but it's important to start a new workout plan with the right expectations.

Building muscle takes much longer than most people realize. It's a slow -- almost excruciatingly slow -- process that can feel discouraging when you don't see the muscle definition you want.

Here you'll learn how long it takes to build muscle and what factors influence your ability to get stronger, leaner and fitter from weight training.

Our Health & Wellness newsletter puts the best products, updates and advice in your inbox.

Each muscle is made up of muscle fibers, which are cylindrical cells. Weight training breaks them down and recovery helps them grow.

Building muscle involves the repair of microtraumas in your muscle fibers. Here's a breakdown of this extremely complex process:

1. Each muscle is made up of thousands of tiny muscle fibers.

2. When you lift weights (or do body weight exercises), your muscles endure tiny injuries throughout their fibers.

3. Then, when you rest your muscles, your body begins repairing your damaged muscle cells.

4. The repair process involves fusing torn muscle fibers back together, as well as laying down new proteins within each muscle cell.

5. Your muscles become bigger and stronger as a result of the repair process.

Keep in mind that the above is a tremendously simplified version of what actually happens in your body after a weight training workout. In reality, the process includes more than just your muscles -- your nervous system, circulatory system and endocrine system all contribute to muscle repair and growth.

Building muscle is super hard. If it was easy, we'd all be ripped.

There's no one muscle-building timeline, because several factors affect your ability to build muscle mass, including:

Your protein intake: While all macronutrients have their roles, protein is king when it comes to building muscle. Your muscles need adequate protein to repair themselves after the stress of weight training. Without enough protein, muscle growth stagnates.

Your calorie intake: If you don't eat enough calories on a daily basis, you won't build muscle even if you eat a lot of protein. To build muscle, your body must create new tissue, and it can't create something from nothing. Extra fuel from extra calories expedites muscle recovery and growth. This is one reason many people never reach their muscle growth goals -- they aren't willing to deal with the extra body fat that comes along with a muscle-building phase.

Your sleep schedule: Lifting weights while sleep-deprived isn't a smart strategy. You might see some gains, but you definitely can't optimize muscle growth when you don't give your body a fighting chance to recover.

Your lifting routine: If you're trying to build muscle, you should know about two key strength training concepts: frequency and volume. Frequency refers to how often you train a muscle or muscle group, while volume refers to the total load you stress a muscle with.

For example, if you perform three sets of 10 reps on squats using 100 pounds, your total volume is 3,000 pounds. More volume and higher frequency typically equate to more muscle, unless you reach the point of overtraining.

Your training age: The more advanced you are, the less muscle growth you'll see (yeah, that sounds backward). Everyone has a maximum genetic potential for muscle growth, and the closer you get to yours, the harder it gets to build more muscle.

Your actual age: Like a lot of things, building muscle gets harder as you get older. Sarcopenia, or loss of muscle mass and function, is actually a big problem in older adults. That's one reason why it's so important to stay active as you get older.

Other major factors include your genetic potential for building muscle (which is impossible to quantify without lab testing, and even then, kind of wishy-washy) and your testosterone levels -- which is why men typically have more muscle than women. Other hormones, including human growth hormone and insulin growth factor also play a role in muscle growth.

All that said, the muscle-building process starts the moment you challenge your muscles to do something. True beginners might see muscle growth within six weeks of starting a resistance training program, and advanced lifters may see results within six to eight weeks of switching up their usual strength training regimen.

Regardless of fitness level, building muscle takes several weeks, even when your diet, sleep and training regimen are all dialed in to optimize muscle growth.

Cardio that involves high-volume weight training can help you build muscle.

This depends on your definition of cardio and your training age. Most people won't build much muscle from traditional cardio, such as walking or jogging, and people who've been training for a long time definitely won't build new muscle through traditional cardio. It doesn't recruit your muscles in a way that sends a muscle-building signal to your body.

However, cardio that involves high-intensity exercises like plyometrics (think jump squats) or high-volume weight training can help you build muscle to an extent. Sprinting hills, hiking, skiing and other outdoor cardio can also contribute a small amount to muscle mass, especially for beginners. People with a long training history may not see as much success with cardio.

Although cardio can improve your overall fitness and help build muscle in select scenarios, strength training remains the best way to build muscle mass.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

See original here:
How long does it take to build muscle? - CNET

Global Endocrine Testing Market was valued US$ XX Bn in 2018 and is expected to reach XX Bn by 2026, at a CAGR of 8.00% during a forecast period.

REQUEST FOR FREE SAMPLE REPORT:https://www.maximizemarketresearch.com/request-sample/33711

The endocrine system plays a vital role in reproduction, growth and sexual development, retorts to injury and stress, body energy level, bone and muscle strength, and also internal balance of the body.

The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

The growing incidence of hormonal imbalances in individuals is one of the key drivers in the global endocrine testing market. Changing lifestyles, growing stress, and unhealthy food habits result in obesity and disturbed hormonal changes, these are some of the driving factors under the growth in global endocrine testing market.

The software has been designed to accomplish the workflow in the laboratories, like new mobile apps have been developed so that patient can be reminded about his appointment or test, and he will be able to contact a physician. These advancements in technology are projected to propel the global endocrine testing market growth over the forecast period.On the other hand, the high cost of technology is projected to be the key restrain for the growth of the global endocrine testing market. Furthermore, an increase in the investment in research and technology is measured as a major opportunity for the growth of the global endocrine testing market.

The thyroid-stimulating hormone (TSH) test is expected to share significant growth in the global endocrine testing market. The significant growth in the market is attributed to the growing incidences of TSH-related disorders, and rising awareness regarding the correlation between variations in the thyroid hormone level and cardiovascular disorders. Furthermore, the Insulin test is expected to grow at a XX % rate of CAGR during the forecast period. The considerable rise in the diabetic population and the rising awareness about diagnosis are expected to contribute towards the demand for an insulin test.

The tandem mass spectrometry is estimated to hold a dominant position in the global endocrine testing market followed by sensor technology segment. The growing use of tandem mass spectrometry in combination with liquid chromatography, which also helps in overcoming challenges associated with traditional techniques are expected to increase the demand for tandem mass spectrometry. On the other hand, sensor technology is projected to grow at a XX % rate of CAGR during the forecast period owing to the increasing use of biosensors in glucose monitoring for diabetes which is used on routine basis by the individuals to monitor their blood sugar level.

Geographically, North America region is estimated to contribute a significant share in the global endocrine testing market. Growing incidence of several types of endocrine diseases, rapid adoption of novel testing techniques supported by regulatory infrastructure and positive recompense scenario are some of the prominent factors behind the growth in the global endocrine testing market.

The objective of the report is to present a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, industry-validated market data and projections with a suitable set of assumptions and methodology. The report also helps in understanding dynamics, structure by analyzing the market segments and, project the global endocrine testing market. The report also provides a clear representation of competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence in the global endocrine testing market. The report also provides PEST analysis, PORTERs analysis, SWOT analysis to address the question of shareholders in arranging the efforts and investment in the near future to a particular market segment.Scope of the Report for Global Endocrine Testing Market

Global Endocrine Testing Market, By Test

Follicle stimulating hormone (FSH) Human Chorionic Gonadotropin (hCG) Thyroid Stimulating Hormone (TSH) Dehydroepiandrosterone sulphate (DHEAS) Prolactin Progesterone Insulin Cortisol Testosterone Estradiol (E2) Luteinizing Hormone (LH)Global Endocrine Testing Market, By Technology

Immunoassay Clinical Chemistry Monoclonal and Polyclonal Antibody Sensor technology Tandem Mass SpectroscopyGlobal Endocrine Testing Market, By End User

Hospitals Physician Offices Health Care Centers Commercial LaboratoriesGlobal Endocrine Testing Market, By Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in Global Endocrine Testing Market

Thermo Fisher Scientific, Inc. Quest Technology Biomedical Technologies. Sysmex Corporation Abbott Laboratories AB Sciex Pte. Ltd. Agilent Technologies Siemens Healthcare Ortho Clinical Technology BioMerieux SA Bio-Rad Laboratories DiaSorin S.p.A F. Hoffmann-La Roche Ltd. Laboratory Corporation of America Holdings

Browse Full Report with Facts and Figures Report at:https://www.maximizemarketresearch.com/market-report/global-endocrine-testing-market/33711/

About Us:

Maximize Market Research provides B2B and B2C market research on 20,000 high growth emerging technologies & opportunities in Chemical, Healthcare, Pharmaceuticals, Electronics & Communications, Internet of Things, Food and Beverages, Aerospace and Defense and other manufacturing sectors.

Contact info:

Name: Vikas Godage

Organization: MAXIMIZE MARKET RESEARCH PVT. LTD.

Email: sales@maximizemarketresearch.com

Contact: +919607065656/ +919607195908

Website:www.maximizemarketresearch.com

Visit link:
Global Endocrine Testing Market: Industry Analysis and Forecast (2019-2026) By Test, Technology, End Use and Region. - Good Night, Good Hockey

Ive written lots of articles about probiotics, microbiota, and the health of your gut, especially in relation to things like heartburn, mental well-being, and simple overall health. As Im currently nine months pregnant, Ive been dealing with quite a few unpleasant gut changes, which led me down a fascinating road of gut types. Who knew that there were actually differenttypes of gut that present physically, mentally, and emotionally!

Each human body is individual and therefore requires individual attention and this goes for your gut too. While probiotics, a plant-based diet, and a physically active lifestyle are all great places to start when boosting your gut health, discovering the exact type of issues going on within your gut will help to tailor the food you eat, the type of exercise you take part in, and what type of supplements may help to alleviate any digestive discomfort.

Lets take a little explorative session into the digestive system, the microbiome, the different types of gut, and how we can care for ourselves as individuals!

When you talk about the gut, youre actually referring to an incredibly complicated system that extends between your mouth all the way to your rectum. This system is the main source of nutrient absorption and storage, its how we energize, and how we get nourishment. Alright, so what makes up your digestive system?

The digestive system includes your mouth, esophagus, stomach, small intestine, large intestine (also called your colon), pancreas, liver, gallbladder, rectum, and anus. As you can tell, the digestive system isnt just located in your mid-section generally where you feel most digestive discomfort such as bloating, gas, or upset stomach but its an entire body, top to bottom, network.

On top of that, your gut or digestive system is riddled with good and bad bacteria called microbiota that make up the microbiome, yet another incredibly complicated ecosystem within your body. Yet, this microbiome has been found to play an integral role in not only your digestive health but also your mental health, the efficacy of nutrient absorption, energy level pretty much your overall bodily health.

Each part of the digestive system has an important part to play! Lets take a look at how your food is processed through this amazing network. Digestion begins in the mouth as your salivary glands get active when you see and smell food. Your saliva then mixes with the food to begin to break it down into a form your body can absorb and use.

Next, your esophagus receives food from your mouth [and] a series of muscular contractions within the esophagus called peristalsis delivers food to your stomach. Finally, weve made it to the stomach! This hollow organ holds food while it is being mixed with stomach enzymes [and strong acid] [that will] continue the process of breaking down food into a usable form.

From there, this new conglomeration of enzyme, acid, and nutrients moves into the small intestine where the work really starts! Your small intestine is a 22-foot long muscular tube made of three segments the duodenum, jejunum, and ileum where your food is further broken down using enzymes released by the pancreas and bile from the liver, as well as peristalsis, which aids the food to move through and mix with digestive juices from the pancreas and liver. The first segment of your small intestine the duodenum is responsible for the continuous breaking-down process, while the lower sections the jejunum and ileum are responsible for absorption of nutrients into the bloodstream.

The resulting semi-solid mixture water, bile, enzymes, and mucus passes into the colon (of the large intestine). The colon is a 6-foot long muscular tube that connects the small intestine to the rectum and its primary goal is to separate the necessary from the waste. While the colon may be shorter than the small intestine, its made up of more parts including the cecum, the ascending (right) colon, the transverse (across) colon, the descending (left) colon, and the sigmoid colon, which connects to the rectum. Once all the nutrients and water have been removed from the mixture, youre left with waste matter, which is stored in the sigmoid (S-shaped) colon until a mass movement empties it into the rectum once or twice a day.

While we dont reallywantto talk about waste, its important to note that theres a lot more going on there than meets the eye. Your waste or stool is mostly food debris and bacteria. Its the bacteria that you want to focus on. These good bacteria perform several useful functions, such as synthesizing various vitamins, processing waste products, and food particles, and protecting against harmful bacteria.

I covered, very briefly, the difference between microbiota referring to the collection of microbes that live in and on the human body and microbiome referring to the complete set of genes within these microbes. One is talking about the entirety and the other refers to the individual or more detailed version of the former. In another of my gut-related articles Understanding the Gut-Hormone Connection I break down the microbiome:

Themicrobiomeis very similar to a mini-ecosystem in which microscopic organisms thrive. These microscopic organisms, also called microorganisms, create a symbiotic environment called themicrobiome and they includebacteria, pathogens infections agents, archaea prokaryote microorganisms, which lack a nucleus, and eukaryotic microbes microorganisms that have a nucleus. Your microbiome is built from yourpersonal environment and lifestyle, such as geography, health status, stress, diet, age, gender, and everything you touch, therefore every humans microbiome isspecial and uniqueto them.

When it comes to the health of your gut or digestive system there are lots of factors that play an important role including exercise, stress, and medication. Yet, one of the most influential factors is your diet. The effects of diet are probably what you would expect.

A diet thats loaded with highly processed and ultra-processed foods which include refined carbs, sugars, hydrogenated oils, and trans fats is severely detrimental to your gut health, while a diet rich in whole, plant-based foods is linked to a healthy gut. This isnt just hearsay, there have been multiple studies conducted at different institutions and within different parameters that come to similar conclusions such as this study published in the European Cardiology Review or this multi-institutional study entitled The Effects of Vegetarian and Vegan Diets on Gut Microbiota.

So, what is it about a plant-based diet that improves gut health? A lot of it has to do with the fact that plant-based diets are naturally anti-inflammatory, yet the other large part is due to the fact that plants are rich in a variety of gut-sustaining nutrients such as dietary fiber, antioxidants, healthy fats, and a diverse range of all the vitamins and minerals. For instance, dietary fiber is known to promote the growth of beneficial bacteria that reduce inflammation and cardiovascular disease risk, as well as increases short-chain fatty acids linked to improved immunity and improved intestinal function.

While fiber is important, its also about incorporating a balanced intake of the proper amount of vitamins, minerals, and macronutrients, while excluding the toxic ingredients of processed foods and high amounts of added sugar. All of these play a factor in your gut health!

Alright, now that we know as much as we can about gut health in as short a period as possible, that is! its probably a good idea to take stock of your own gut health. Digestive issues are a pervasive issue in the states. Per the Centers for Disease Control and Prevention, 22.4 million people were diagnosed with a digestive disorder or disease by their physician, while 8.3 million people were separately diagnosed in the emergency room.And this doesnt account for physician or emergency room visits for less severe digestive disorders such as painful gas, diarrhea or constipation, excessive bloating, or upset stomachs.

Most likely, everyone reading this article has one or two gripes about their digestive system! Where do you start? Figure out what type of gut youve got and learn how to properly care for it so you can balance out that microbiome and avoid products and foods that may cause disrupt.

Candida is a genus of yeasts that is typically found in small amounts in the mouth and intestines and on the skin. Its actually quite normal to have small amounts of candida throughout your life, yet when that amount begins to grow uncontrollably, it can cause an infection known as candidiasis, which happens to be the most common cause of fungal infections in humans.

This condition can manifest in weight gain, phlegmy coughs and sniffles, and a white coating on the tongue.Those with a candida gut generally desire foods rich in sugar, dairy, and wheat and are generally incredibly worrisome, anxious, and obsessive.

If youre looking to heal yourself, its recommended to eat a lot of soups, stews, and warm starchy veggies, such as this Chickpea Miso Noodle Soup or these Cinnamon Turmeric Sweet Potatoes fermented foods, such as these Potato Kimchi Pancakes or this Homemade Raw Sauerkraut and incorporate a good probiotic such as this Garden of Life Whole Food Probiotic Supplement, this Florastor Daily Probiotic Supplement, or this Hyperbiotics PRO-15 Probiotic. On the other hand, make sure to avoid dairy, sugar, refined grains, raw foods, and yeast.

A gastric gut is directly linked to your lifestyle, self-care routine, and a slow-moving digest system. In particular, it means that youre overworking and overexerting yourself. This mixture overworking and a slow-moving digestive system leads to habits that cause poor digestion such as not chewing properly, overeating, and taking antacids.

This condition manifests with issues such as gas, bloating, and acid reflux, as well as habits such as eating your food too fast. If youve got this gut type, you most likely are a fiery, passionate, and reactive personality type as well!

If youre looking to heal, try to eat several small meals and stop before youre full, load up on bitter veggies, herbs, and citrus, drink mineral water, [and] supplement with digestive enzymes, such as this Pure Vegan Digestive Enzyme Complex, these Mary RuthsVegan Digestive Food Enzymes, or this Garden of Life Organic Chewable Enzyme Supplement. On the other hand, youll want to avoid alcohol, caffeine, fried foods, and spicy foods. Try a few of these plant-based recipes that are rich in bitter veggies, herbs, and citrus: 10-Minute Seitan Beef and Broccoli, Braised Kale, Cilantro Lime Tacos, Alkaline Green Juice, or this Avocado Grapefruit Jicama Salad.

You may think that a gastric and stressed gut are the same thing and while they may have similarities, theyre actually quite different! A stressed gut is caused by the constant circulation of stress hormones, which diverts blood flow away from your gut and impairs the growth of good bacteria and digestive enzyme production.

The condition usually manifests in adrenal fatigue, which causes sleep issues, decreased libido, and trouble focusing. These folks tend to consume too much coffee and/or too much alcohol and generally have a type-A workaholic personality.

If youre looking to heal, incorporate salty, dark-colored foods, such as this Vietnamese Purple Yam Soup or these Homemade Dark Chocolates supplement with B vitamins, and look into getting some adaptogens into your life such as these Natures Way Astragalus Root Capsules, these Pure Mountain BotanicalsHoly Basil Capsules, or this NaturaLife LabsOrganic Maca Root Black, Red, Yellow.

Make sure to avoid alcohol, caffeine, refined grains, and sugar.

One of the main culprits behind an immune gut is food sensitivities most commonly, gluten and dairy. Unfortunately, there are a few factors that are somewhat unavoidable that can cause an immune gut including longtime use of antibiotics, birth control pills, and steroids.

An immune gut is treatable, but at its worst results in autoimmune disorders and inflammatory bowel diseases. Those with this type of gut generally have a habit of going for the antibiotics on a regular basis and are usually perfectionists, insecure, and detail-oriented personality types.

If youre looking to heal an immune gut, its a bit more complicated than other types. First off, youll want to pair up with your doctor, nutritionist, or dietitian in order to work out an elimination diet in order to find out exactly what youre sensitive too. Next, its recommended to focus on reestablishing the health of your gut through supplemental digestive enzymes, soil-based (SBO) probiotics, and L-glutamine. Also, think about incorporating healthy fats on a daily basis think avocado, nuts, seeds, and coconut oil! On the other hand, steer clear of alcohol, dairy, raw foods, and packaged foods.

Find the perfect probiotic and digestive enzyme for your body using the following guide articles 10 Vegan Digestive Enzyme Supplements and Vegan Probiotics: How To Get Them From Supplements and Food

And then try out some of these healthy fat-filled recipes: Garden Green Soup, Peach, Raspberry and Coconut Yogurt Chia Pudding, Brussels Sprouts Salad with Macadamias and Apple, Avocado Pesto Pasta, or this Super Quick Chocolate Porridge.

Last, but not least, the toxic gut!

This type of gut is actually caused by the Standard American Diet basically, eating processed or fast food. As mentioned earlier, processed and ultra-processed foods are incredibly detrimental to your gut microbiome, so much so that eating too many are referred to as toxic. By eating processed foods, youre actually eating unhealthy fat, sugar, and chemicals.

This condition manifests in an inflammatory chain reaction from our liver to our intestines, leading to symptoms ranging from gallstones to rosacea to neurological distress. People who suffer from toxic gut generally are impatient, frequently frustrated, and quick to anger personality types. If youre looking to heal a toxic gut, incorporate an abundance of raw, green, and/or sour foods, drink dandelionormilk thistle tea, [and]get more sleep. On the other hand, avoid alcohol, non-organic produce, fried foods, nut butter, [and] oils.

Try some of these recipes that are rich in raw, green, and sour foods: Raw Cranberry Coconut Energy Bars, Carrot Ginger Soup With Curried Raisin Relish, Spinach Potato Soup, Thai Tempeh Collard Greens Wraps, Fizzy Pink Grapefruit Lemonade, or these Super-Easy Refrigerator Dill Pickles.

Learning everything you can about gut health is an excellent step towards a better functioning body! From boosting energy to smoothing out digestion to absorbing more nutrients and even conquering mental health issues, starting with the gut is a great idea!

Homemade Probiotic Cashew Yogurt/One Green Planet

Reducing your meat intake and eating more plant-based foods is known to help withchronic inflammation,heart health,mental wellbeing,fitness goals,nutritional needs,allergies,gut health,andmore! Dairy consumption also has been linked to many health problems, includingacne,hormonal imbalance,cancer,prostate cancerand has manyside effects.

For those of you interested in eating more plant-based, we highly recommend downloading theFood Monster App with over 15,000 delicious recipes it is the largest plant-based recipe resource to help reduce your environmental footprint, save animals and get healthy! And, while you are at it, we encourage you to also learn about theenvironmentalandhealth benefitsof aplant-based diet.

Here are some great resources to get you started:

For more Animal, Earth, Life, Vegan Food, Health, and Recipe content published daily, subscribe to theOne Green Planet Newsletter! Lastly, being publicly-funded gives us a greater chance to continue providing you with high-quality content. Please considersupporting usby donating!

See more here:
A Guide to Your Gut Type and What This Means for Your Diet - One Green Planet