Archive for December, 2019

Pigs engineered to have a small amount of monkey cells have been brought to full term and were even born alive, surviving for a few days after birth. Although the piglets died, it is claimed the experiment - performed in China - marks a major milestone for the future of lab-grown organs.

"This is the first report of full-term pig-monkey chimeras," Tang Hai of the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing told New Scientist.

The research is part of an ongoing effort to develop animals - whether they are sheep or pigs - that can grow human organs we could then harvest for transplants, a process called xenogeneic organogenesis.

Research has been done on both pig and sheep embryos with transplanted human stem cells; in both cases, the embryos continued to develop until the experiment was deliberately terminated.

That's because, due to ethical concerns, these chimeras - organisms that incorporate the genetic material of another species - cannot be cultivated or studied in the later stages of embryonic development. Some scientists worry that some of the human stem cellscould end upin other parts of the animal or even in its brain, with unintended consequences.

For that reason, in this experiment the team used stem cells from crab-eating macaques (Macaca fascicularis). These were imbued with fluorescent proteins so that they would glow under fluorescent light, and derived to produce fluorescing embryonic cells.

These cells were then injected into over 4,000 five-day-old pig embryos fertilised using IVF; the modified pig embryos were subsequently implanted into sows.

This fiddly and painstaking work produced just 10 piglets that made it to full term and were born alive. And only two of these were chimeric, with between one in 1,000 and one in 10,000 functional monkey cells to pig cells.

The monkey cells had migrated to the heart, liver, lungs, spleen and skin of the piglet hosts, but were not found in other organs, such as testes and ovaries, due to the low rate of chimerism, the researchers said.

Sadly, before a week was out, the piglets died - not just the two chimeras, but the other eight normal piglets, too. Because all the pigs died, Hai told New Scientist, the cause of death likely had less to do with chimerism, and more to do with IVF - a procedure that is notoriously tricky in pigs.

The low chimerism rate is also somewhat discouraging. However, the researchers remain optimistic. Although the birth rate was low, and the pigs didn't survive, the team now has a wealth of data they can apply to future experiments.

The scientists are planning to try again, increasing the chimeric cell ratio. And they believe their data may help other scientists working in the field.

"Here, we have used monkey cells to explore the potential of reconstructing chimeric human organs in a large animal model," they wrote in their paper.

"We believe this work will facilitate the development of xenogeneic organogenesis by providing a better understanding of the processes of xenogeneic recognition, fate determination, and the proliferation and differentiation of primate stem cells during porcine development.

"The findings could pave the way toward overcoming the obstacles in the re-engineering of heterogeneous organs and achieve the ultimate goal of human organ reconstruction in a large animal."

The research has been published in Protein & Cell.

Originally posted here:
Pig-Monkey Chimeras Have Been Brought to Term For The First Time - ScienceAlert

By Michael Le Page

Tang Hai

Pig-primate chimeras have been born live for the first time but died within a week. The two piglets, created by a team in China, looked normal although a small proportion of their cells were derived from cynomolgus monkeys.

This is the first report of full-term pig-monkey chimeras, says Tang Hai at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing.

The ultimate aim of the work is to grow human organs in animals for transplantation. But the results show there is still a long way to go to achieve this, the team says.

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Hai and his colleagues genetically modified cynomolgus monkey cells growing in culture so they produced a fluorescent protein called GFP. This enabled the researchers to track the cells and their descendents. They then derived embryonic stem cells from the modified cells and injected them into pig embryos five days after fertilisation.

More than 4000 embryos were implanted in sows. Ten piglets were born as a result, of which two were chimeras. All died within a week. In the chimeric piglets, multiple tissues including in the heart, liver, spleen, lung and skin partly consisted of monkey cells, but the proportion was low: between one in 1000 and one in 10,000.

It is unclear why the piglets died, says Hai, but because the non-chimeric pigs died as well, the team suspects it is to do with the IVF process rather than the chimerism. IVF doesnt work nearly as well in pigs as it does in humans and some other animals.

The team is now trying to create healthy animals with a higher proportion of monkey cells, says Hai. If that is successful, the next step would be to try to create pigs in which one organ is composed almost entirely of primate cells.

Something like this has already been achieved in rodents. In 2010, Hiromitsu Nakauchi, now at Stanford University in California, created mice with rat pancreases by genetically modifying the mice so their own cells couldnt develop into a pancreas.

In 2017, Juan Carlos Izpisua Belmontes team at the Salk Institute in California created pig-human chimeras, but only around one in 100,000 cells were human and, for ethical reasons, the embryos were only allowed to develop for a month. The concern is that a chimeras brain could be partly human.

This is why Hai and his team used monkey rather than human cells. But while the proportion of monkey cells in their chimeras is higher than the proportion of human cells in Belmontes chimeras, it is still very low.

Given the extremely low chimeric efficiency and the deaths of all the animals, I actually see this as fairly discouraging, says stem cell biologist Paul Knoepfler at the University of California, Davis.

He isnt convinced that it will ever be possible to grow organs suitable for transplantation by creating animal-human chimeras. However, it makes sense to continue researching this approach along with others such as tissue engineering, he says.

According to a July report in the Spanish newspaper El Pas, Belmontes team has now created human-monkey chimeras, in work carried out in China. The results have not yet been published.

While interspecies chimerism doesnt occur naturally, the bodies of animals including people can consist of a mix of cells. Mothers have cells from their children growing in many of their organs, for instance, a phenomenon called microchimerism.

Journal reference: Protein & Cell, DOI: 10.1007/s13238-019-00676-8

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Exclusive: Two pigs engineered to have monkey cells born in China - New Scientist News

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Top Florida Medical Spa, Amnion of Florida, Partners With Merakris Therapeutics to Advance Their Non-Surgical Treatment Options - Business Wire

Millions of people around the world have some form of sight or hearing loss, have no sense of smell or taste or have lost limbs, taking away their sense of touch. Fortunately, the science of senses is the most advanced its ever been. Biotech researchers are developing methods that merge humans and machines in ways that could restore human abilities to hear, see, taste, smell and touch. From neuro-prosthetic limbs that mimic touch to bionic eyes and smart glasses that restore sights, the innovations could drastically improve the quality of life of people around the world.

Some of the most advanced technology developed around the science of senses comes from the field of prosthetic limbs, where researchers are finding ways to connect tissue to metal. Systems called brain-machine interfaces literally wire robotic limbs to a persons nervous system. Two of the latest achievements were reported in July 2019 in the journal Science Robotics.

In the first, a team from the University of Utah connected a robotic hand and partial forearm to the remaining nerves in the mans arm. The man trained his brain to control the motion of the hand. At the same time, artificial zaps sent to the robotic hand were designed to mimic the skins natural response patterns to touch. Remarkably, the man could more easily discriminate between small and large objects as well as soft and hard items while blindfolded and wearing headphones. Another team, based at the National University of Singapore, engineered flexible, electronic skin that contains artificial nerves that transmit signals 1,000 times faster than nerves in human skin. The skin is able to sense temperature, pressure and humidity and is also durable enough to function even if it is scratched or damaged.

Since the mid-1980s, a tiny electronic device called a cochlear implant has been providing the sense of sound to hundreds of thousands of people worldwide, according to the National Institutes of Health. Part of the implant is surgically placed under the skin behind the ear, with another part attached in the same position externally. A third part is inserted inside the ear canal. Unlike a hearing aid that amplifies sound, a cochlear implant senses sounds and converts them into an electric signal that it uses to stimulate a persons auditory nerve. Even people who are profoundly deaf can learn to discern sounds as long as some fraction of their nerve still functions.

But cochlear implants are not perfect. They are only capable of sensing and transmitting part of a sound waves full audio spectrum, producing a sound that has a metallic quality. That can make it difficult to filter out background noise, such as a crowd conversations or traffic. In 2019, a team from the University of Greenwich in England reported on new research that improves upon this technology, reports MedicalXpress. It deconstructs sounds from the environment and then reconstructs them with 90% to 100% percent efficiency. This means patients will be able to better distinguish noises from background sounds.

Smell loss, called anosmia, affects about 5% of the general population, according to the Massachusetts Eye and Ear Infirmary. The condition may be the result of something temporary, such as a sinus infection or swelling or polyps in the nasal cavity or it could be the result of damage to the sensory nerves. Permanent loss of smell can impact daily enjoyment of life and even affect safety. The inability of smelling smoke or natural gas could put someone in harms way.

Although there is no proven therapy, researchers at the Massachusetts Eye and Ear have, for the first time, invented a device that stimulates different smells. Their technology, which they reported in 2018 in the International Forum of Allergy & Rhinology, uses an array of tiny electrodes to send an electrical signal to the olfactory bulb, a structure in the brain involved in smell. In a small experiment, the scientists created different electrical stimulation in five patients, producing smells similar to onions and antiseptic as well as sour and fruity aromas. Although the innovation is still in the early stage, it demonstrates a possible path forward for a cochlear implant for the nose, the scientists say.

Although smell is connected to taste, its the receptor cells on the taste buds of a persons tongue that discern sweet, salty, sour, bitter or savory flavors. Medical procedures inside the mouth or ear can alter a persons taste, as can head trauma or ear infections, according to MedicineNet. Scientists have made a couple of attempts to solve the problem with technology. Back in 2013, a team from the National University of Singapore developed a taste simulator that used a kind of electronic tongue depressor to simulate taste sensations, New Scientist reported. Later, another team at City University of London invented a similar device called Taste Buddy that also stimulated taste buds to alter the flavor of foods, reported Digital Trends.

Unfortunately, neither gadget went beyond the research lab. For now, solutions may lie within human DNA. Lynnette McCluskey, a neurobiologist at the Medical College of Georgia at Augusta University, and her team are investigating whether a protein called interleukin-1, or IL-1, secreted during an injury could help rebuild a persons sense of taste. The protein promotes inflammation and also helps regulate nerve growth. In 2018, she and her colleagues received grant money to study whether manipulating the proteins after an injury could help the nerves associated with taste recover faster, reports MedicalXpress. It could take a few more years to find out.

Worldwide, 36 million people are legally blind, according to Nature. Some biotechnological solutions, such as growing stem cells into those that can repair damage to the retina or using techniques from gene therapy to correct genetic defects, are showing promising results. But technology is also playing a big role.

A bionic eye, called the Argus II, is a retinal prosthesis system that, since its development in early 2000, has restored some vision capabilities to more than 300 people. Its reserved for people who have no vision or almost no vision due to a genetic condition called retinitis pigmentosa. Patients undergo surgery, in which a tiny electronic device is attached to the persons retina. Its connected wirelessly to a pair of smart glasses that have a portable video-processing unit that project images from the outside world onto the persons retina. Clinical trials done in 2015 showed that visual function improved in 90% of people wearing the prosthesis and that 80% of patients reported improved quality of life, according to the American Academy of Ophthalmology.

Advances in technology are allowing machines to merge with the human body. Coupled with our growing ability to correct genetic defects or repair cellular damage, the science of senses is moving into the future. One day all humans could move through the world with all five of their senses intact seeing the unseen, hearing the unheard and tasting, touching and smelling new wonders that evoke all of the pleasures of being alive.

Being on the forefront of change, especially regarding space, physics, and engineering has been part of the Northrop Grumman culture for generations. Click here tosearch jobs in these areas of scientific innovation.

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Global Stem Cell Therapy Market From TMRRs Viewpoint

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TMRR, in its latest business report elaborates the current situation of the global Stem Cell Therapy market in terms of volume (x units), value (Mn/Bn USD), production, and consumption. The report scrutinizes the market into various segments, end uses, regions and players on the basis of demand pattern, and future prospect.

In this Stem Cell Therapy market study, the following years are considered to project the market footprint:

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On the basis of product type, the global Stem Cell Therapy market report covers the key segments, such as

Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy market players Player 1, Player 2, Player 3, and Player 4, among others represent the global Stem Cell Therapy market. The market study depicts an extensive analysis of all the players running in the Stem Cell Therapy market report based on distribution channels, local network, innovative launches, industrial penetration, production methods, and revenue generation. Further, the market strategies, and mergers & acquisitions associated with the players are enclosed in the Stem Cell Therapy market report.

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Growing Focus on Product Innovation Likely to Impact the Growth of the Stem Cell Therapy Market 2017 - 2025 - Weekly Spy

Beijing: In a world first, researchers have been able to produce pig-monkey hybrids in a Chinese laboratory, a media report said. Two piglets - having monkey tissues in their hearts, liver and skin - were born in the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing but died within a week, the Mirror reported.

The announcement to this effect was made by Tang Hai. The experiment comes in the wake of Spanish scientist Juan Carlos Izpisua Belmonte's attempt to create pig-human hybrids two years ago. Tang and his team injected genetically modified monkey cells into more than 4,000 pig embryos before these were implanted into sows, the New Scientist magazine reported.

Only two of the 10 piglets thus born were hybrids - with tissues in the heart, liver, spleen, lung and skin, partly consisting of monkey cells. Experts suspected that the failure has to do with the IVF process.

Critics have now warned that the scientific development will create "disturbing" dilemmas over the ethics of human-animal hybrids. Doctor Angel Raya, director of the Barcelona Regenerative Medicine Centre, told the Spanish daily El Pais: "What happens if the stem cells escape and form human neurons in the brain of the animal? Would it have consciousness? And what happens if these stem cells turn into sperm cells?''

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Meet the world's first pig-monkey hybrid - Free Press Journal

Researchers in China are laying claim to the first ever pig-monkey chimeras to be born in what they hope will be a breakthrough for biomedicine, not just fuel for your nightmares.

The worlds first monkey-pig hybrids have been born in a Chinese lab amid scientific attempts to grow human organs inside animals. The incredible experiment saw two chimera piglets born with DNA from both pigs and cynomolgus monkeys. However, the experiment was short-lived as the two piglets both died within a week.

According to the researchers, the baby piglets had genetic material from cynomolgus monkeys in their heart, liver, spleen, lung and skin.

However, the success rate was significantly low as only 10 piglets were born from more than 4,000 implanted in sows.

From those, only two were chimeras in a result that has been deemed discouraging by other leading stem cell scientists.

Lead researcher Tang Hai at the State Key Laboratory of Stem Cell and Reproductive Biology in Beijing said: This is the first report of full-term pig-monkey chimeras.

Ms Hai confirmed that it was unclear why the piglets died, but the non-chimeric pigs died as well.

The Chinese research team suspect that the deaths could have been due to the IVF process instead than the chimerism

According to research study, stem cells from macaque monkeys were grown in a lab and then injected into pig embryos five days after fertilisation.

Ms Hai said that the next step in their research was to create healthy animals with a higher proportion of monkey cells before creating pigs in which one organ is composed almost entirely of primate cells.

The ultimate research goal is to grow human organs inside live animals as a way to resolve the crisis of organ transplantation.

University of California stem cell biologist Paul Knoepfler said: Given the extremely low chimeric efficiency and the deaths of all the animals, I see this as fairly discouraging.

Reaction to the study has prompted many social media users to question if this is a step too far.

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Researchers Manage to Create Pig-Monkey Chimeras for the First Time - Tdnews

WALTHAM, Mass., Dec. 10, 2019 /PRNewswire/ --Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced that it plans to commence a Phase 2 expansion cohort based on encouraging clinical activity and a well-tolerated safety profile observed to date in the ongoing Phase 1 dose escalation trial of SNDX-6352 in patients with chronic graft versus host disease (cGVHD). SNDX-6352 is the Company's anti-CSF-1R monoclonal antibody.

The ongoing Phase 1, open-label, modified 3+3 dose escalation trial is designed to evaluate the safety and preliminary efficacy of SNDX-6352 in up to 30 patients with cGVHD who have received at least two prior lines of therapy. As of a November 25, 2019 data cutoff date, a total of five patients, all of whom received prior treatment with ibrutinib, steroids, and a calcineurin inhibitor, have been enrolled across three dose cohorts: one patient was treated at 0.15 mg/kg every two weeks (Q2W, Cohort 1), one is receiving a dose of 0.5 mg/kg Q2W (Cohort 2), and three patients are receiving 1.0 mg/kg Q2W (Cohort 3).

Responses have been observed in all evaluable patients as of the data cutoff date, with no dose limiting toxicities (DLTs) reported. Among the three patients dosed in Cohort 3 (1.0 mg/kg Q2W), one patient recently cleared the DLT period and has not yet been evaluated for efficacy, two patients experienced a partial response, and all three patients remain on therapy. The patient in Cohort 2 experienced a partial response and is currently in their ninth month of treatment with SNDX-6352 following prior treatment with ibrutinib and both Jakafi (ruxolitinib) and KD025, two agents currently being investigated for the treatment of cGVHD. The first patient (Cohort 1) achieved a partial response but discontinued in their third cycle due to elevated LFTs attributed to progression in their liver cGVHD. Cohort 4, which will explore a 3.0 mg/kg Q2W dose, is now open for enrollment.

"The initial results from our Phase 1 trial underscore the potential of SNDX-6352 to serve as an effective therapy for patients with cGVHD who are lacking alternative options," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We had not anticipated commenting on data from this initial trial until the second half of 2020, so it is quite encouraging to see the early signs of activity in patients with this difficult to treat disease. Based on these results, we have decided to advance into a Phase 2 expansion cohort to evaluate additional patients at the 1.0 mg/kg dose while we continue the dose escalation to 3.0 mg/kg. We continue to expect to present the Phase 1 trial results in the second half of 2020.

"Published preclinical data have demonstrated that CSF-1R blockade can prevent and treat disease in animal models of cGVHD1," said Peter Ordentlich, Ph.D., Chief Scientific Officer and Co-founder of Syndax."The initial data from our trial provide the first clinical evidence that targeting CSF-1R dependent macrophages may benefit patients with cGVHD."

To date, SNDX-6352 has been safe and well-tolerated, with no DLTs observed. Dose escalation is ongoing in the Phase 1 portion of the trial. The Phase 2 expansion cohort is expected to enroll up to 22 patients to further characterize the safety and efficacy at an initial dosing schedule of 1.0 mg/kg of SNDX-6352 administered every two weeks.

About Chronic Graft Versus Host Disease

Chronic graft versus host disease (cGVHD), an immune response of the donor-derived hematopoietic cells against recipient tissues, is a serious, potentially life-threatening complication of allogeneic hematopoietic stem cell transplantation (HSCT) which can last for years. cGVHD is estimated to develop in approximately 40% of transplant recipients, and affect approximately 14,000 patients in the US. 2-4 cGVHD typically manifests across multiple organ systems, with the skin and mucosa being commonly involved, and is characterized by the development of fibrotic tissue.

About SNDX-6352

SNDX-6352 is an investigational monoclonal antibody that targets colony stimulating factor-1 receptor, or CSF-1R, a cell surface protein thought to control the survival and function of monocytes and macrophages. In pre-clinical models, inhibition of signaling through the CSF-1 receptor has been shown to reduce the number of disease-mediating macrophages and the development of cutaneous and pulmonary chronic graft versus host disease (cGVHD), as well as to lead to the depletion of cells known as Tumor Associated Macrophages, or TAMS. SNDX-6352 is currently being evaluated in a Phase 1 multiple ascending dose clinical trial in cGVHD, and a Phase 1 multiple ascending dose clinical trial as monotherapy and in combination with Infinzi (durvalumab) in solid tumors. SNDX-6352 has the potential to treat a variety of solid tumor and immune-related diseases.

About Syndax Pharmaceuticals, Inc.

Syndax Pharmaceuticalsis a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Company's lead product candidate, entinostat, a once-weekly, oral, small molecule, class I HDAC inhibitor, is being tested in a Phase 3 combination trial with exemestane for treatment of advanced HR+, HER2- breast cancer and has been evaluated in combination with several approved PD-1/PD-(L)1 antagonists. The Company's pipeline also includes SNDX-6352, a monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor, and SNDX-5613, a highly selective inhibitor of the MeninMLL binding interaction. For more information, please visitwww.syndax.comor follow the Company on TwitterandLinkedIn.

Syndax's Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of our product candidates to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical trials, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

References

1. Alexander, KA. et al. J Clin Invest. 2014;124(10):42664280.

2.Kantar GVHD Expert Interviews N=8 interviews

3. SmartAnalyst 2017 SmartImmunology Insights chronic GVHD report.

4. Bachier, CR. et al. ASH annual meeting 2019; abstract #2109 Epidemiology and Real-World Treatment of Chronic Graft-Versus-Host Disease Post Allogeneic Hematopoietic Cell Transplantation: A U.S. Claims Analysis.

Syndax Contacts

Investor ContactMelissa ForstArgot Partnersmelissa@argotpartners.com212.600.1902

Media ContactCraig HeitGCI Healthcraig.Heit@gcihealth.com347.451.4733

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Syndax Pharmaceuticals Announces Plans to Commence Phase 2 Expansion Cohort of SNDX-6352 for the Treatment of Chronic Graft Versus Host Disease -...

SEATTLE--(BUSINESS WIRE)--Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, presented Phase 1 data yesterday from the healthy volunteer study of ALPN-101, a first-in-class dual CD28/ICOS antagonist, and details on its upcoming Phase 1/2 BALANCE study of ALPN-101 in steroid-resistant or steroid-refractory acute graft-versus-host disease (GVHD) at the 61st American Society of Hematology Annual Meeting (ASH) in Orlando, FL.

Jan Hillson, MD, Senior Vice President of Clinical Development at Alpine, presented An Open Label Study of ALPN-101, a First-in-Class Dual CD28/ICOS Antagonist, in Subjects with Steroid-Resistant or Steroid-Refractory Acute Graft Versus Host Disease (BALANCE) as part of the oral session, Chemical Biology and Experimental Therapeutics: Novel Compounds and Mechanisms of Action.

Highlights included:

Despite decades of intense research, GVHD remains a major cause of morbidity and mortality after hematopoietic stem cell transplantation, commented Sophie Paczesny, MD, PhD, Professor of Immunology and Pediatrics at Indiana University School of Medicine and lead of the Biomarkers Stem Cell Transplantation Program and one of Alpine's research collaborators. Current therapies are associated with significant toxicities or are simply insufficient to control the disease. CD28 and ICOS appear to be key pathways in the pathogenesis of GVHD, and the presented data with ALPN-101 appear uniquely strong. I look forward to the BALANCE study, which may demonstrate the therapeutic potential of ALPN-101.

About Graft Versus Host Disease (GVHD)

Graft versus host disease (GVHD) is the most common life-threatening complication of a hematopoietic cell transplant. It occurs when donor cells see recipient cells as foreign and attack them. Acute GVHD typically occurs within the early weeks and months after transplant, usually involving the skin, liver, and gastrointestinal tract. GVHD patients remain at risk of organ system damage and increased mortality due to the disease and to high dose glucocorticoids.

About ALPN-101

ALPN-101 is a novel Fc fusion protein of a human inducible T cell costimulator ligand (ICOSL) variant immunoglobulin domain (vIgD), and a first-in-class therapeutic designed to inhibit simultaneously the CD28 and ICOS inflammation pathways. CD28 and ICOS are closely-related costimulatory molecules with partially overlapping roles in T cell activation likely playing a role in multiple autoimmune and inflammatory diseases. In preclinical models of graft versus host disease, inflammatory arthritis, connective tissue disease, and multiple sclerosis, ALPN-101 demonstrates efficacy superior to agents blocking the CD28 CD80/86 or ICOS - ICOSL pathways alone.

About Alpine Immune Sciences, Inc.

Alpine Immune Sciences, Inc. is committed to leading a new wave of immune therapeutics, creating potentially powerful multifunctional immunotherapies to improve patients lives via unique protein engineering technologies. Alpine has two lead programs. The first, ALPN-101 for autoimmune/inflammatory diseases, is a selective dual T cell costimulation blocker engineered to reduce pathogenic T and B cell immune responses by blocking ICOS and CD28. ALPN-101 has recently completed enrollment in a Phase 1 healthy volunteer trial. The second, ALPN-202 for cancer, is a conditional CD28 costimulator and dual checkpoint inhibitor. Alpine is backed by world-class research and development capabilities, a highly-productive scientific platform, and a proven management team. For more information, visit http://www.alpineimmunesciences.com.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our platform technology and potential therapies, the timing of and results from clinical trials and pre-clinical development activities, clinical and regulatory objectives and the timing thereof, expectations regarding the sufficiency of cash to fund operations, the potential efficacy, safety profile, future development plans, addressable market, regulatory success, and commercial potential of our product candidates, the timing of our public presentations and potential publication of future clinical data, the efficacy of our clinical trial designs, expectations regarding our ongoing collaborations, and our ability to successfully develop and achieve milestones in our development programs. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions and include words such as may, will, should, would, expect, plan, intend, and other similar expressions, among others. These forward-looking statements are based on current assumptions that involve risks, uncertainties, and other factors that may cause actual results, events, or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our product candidates; our ongoing discovery and pre-clinical efforts may not yield additional product candidates; our discovery-stage and pre-clinical programs may not advance into the clinic or result in approved products; any of our product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones in our proprietary or partnered programs; the impact of competition; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we undertake no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

Secreted Immunomodulatory Proteins, SIP, Transmembrane Immunomodulatory Protein, TIP, Variant Ig Domain, vIgD and the Alpine logo are registered trademarks or trademarks of Alpine Immune Sciences, Inc. in various jurisdictions.

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Alpine Immune Sciences Presents ALPN-101 Phase 1 Healthy Volunteer Study Data and Details of Upcoming Phase I/II BALANCE GVHD Study at the 61st...

Dec. 7, 2019 22:30 UTC

LYON, France--(BUSINESS WIRE)-- MaaT Pharma announced today that leading hemato-oncological experts presented clinical data on the compassionate use of MaaT Pharmas lead full-ecosystem microbiome restoration biotherapeutic, MaaT013. The data included eight patients that developed gastrointestinal-predominant, acute Graft-versus-Host-Disease (GI aGvHD) after receiving an allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT) to treat their hematologic malignancies. All patients were positively impacted by the MaaT013 treatment, with three patients achieving complete response. GvHD, a condition where the transplant donors immune cells attack the patients tissues, is one of the most serious complications of allo-HSCT, and its acute GI form is fatal in most cases. MaaT013 features a consistently high diversity and richness of microbial species in their natural environment. It aims to restore the symbiotic relationship between microbes in the gut and the immune system of the patient to correct the responsiveness and tolerance (homeostasis) of immune functions and thereby contain GI GvHD. The results were presented in a poster presentation on December 7, 2019 during the 61st American Society of Hematology (ASH) Annual Meeting and Exposition held in Orlando, Florida.

The GI aGvHD patients who were treated with MaaT013 had a very poor prognosis with no other therapeutic options. The results following MaaT013 administration showed a positive impact on all patients, commented Professor Mohamad Mohty, MD, PhD, Head of the Hematology and Cellular Therapy Department at Sorbonne University, Saint Antoine Hospital in Paris. The most impressive results were seen in those patients who achieved a complete response and who were able to taper and stop using steroids and other immunosuppressants without relapse of gastrointestinal symptoms.

In the presented evaluation, eight patients with a median age of 67 were treated for classical aGvHD, late-onset aGvHD or aGvHD with overlap syndrome that were either steroid-resistant or steroid-dependent following stem cell transplantation. These patients had previously been treated with and failed up to five lines of systemic therapy for aGvHD. Each patient received at least one and up to three doses of MaaT013 and treatment response was evaluated seven days after each administration and on day 28 after the first dose. Based on the best response to the treatment, all eight patients experienced at least a partial response with three patients achieving complete response, two patients with very good partial response and three patients with partial response. Overall, the data demonstrated that reintroduction of a full-ecosystem microbiota provided therapeutic effect and was tolerated in a satisfactory manner in these patients.

Herv Affagard, Co-founder and CEO of MaaT Pharma added, We provided our cGMP-manufactured lead biologic drug, MaaT013, to hospitals as part of a compassionate use program to give GI GvHD patients a therapeutic option where there are no other available treatments after steroids and additional lines of treatment. These findings indicate that reestablishing the gut microbiome improved outcomes in these patients.

Moreover, MaaT Pharma is currently conducting the HERACLES Phase II clinical trial (NCT03359980) to evaluate the safety and efficacy of MaaT013 in steroid-refractory, GI aGvHD patients, with more than half of the patients enrolled.

To date, a total of 46 patients with GI GvHD have been treated with MaaT013, including patients under compassionate use and patients enrolled in the Phase II clinical trial. MaaT Pharma is actively developing an oral formulation of MaaT013 (a capsule, MaaT033) to provide easier administration for patients while delivering a similar effect of regenerating the microbial ecosystem with the goal of restoring immune homeostasis in the gut.

The poster can be viewed on the companys website under News.

About HERACLES

The HERACLES study is a multi-center, single-arm, open-label study, enrolling 32 patients to evaluate the efficacy and safety of MaaT Pharmas lead microbiome restoration drug candidate, MaaT013, in steroid-resistant, gastrointestinal-predominant aGvHD patients. Acute GvHD is a serious, often fatal syndrome typically involving the gut, skin, and liver. Treatments up to now focused largely on suppressing the immune reaction that is induced by the donor cells derived from the hematopoietic stem cell graft reacting against the host. These strategies have remained clinically unsuccessful in most cases, with mortality rates around 80% after twelve months in steroid-resistant cases. Patients with hematological malignancies receive multiple courses of chemotherapy, antibiotics, and ultimately conditioning before HSCT, which are known to severely impact the gut microbial composition.

About MaaT013

MaaT013 is the first full-ecosystem, off-the-shelf, reproducible, enema formulation manufactured using MaaT Pharmas integrated Microbiome Restoration Biotherapeutic (MMRB) platform. The product has a stability of up to 24 months and is characterized by a high diversity and consistent richness of microbial species derived from pooled healthy donors and manufactured at the companys centralized European cGMP production facility. MaaT013 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is already being administered in compassionate use.

About MaaT Pharma

MaaT Pharma, a clinical stage company, has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and Graft-versus-Host-Disease, a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into improving outcomes of immunotherapy in solid tumors, we have built a powerful discovery and analysis platform, GutPrint, to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our biotherapeutics are produced under the strictest cGMP manufacturing and quality control process to safely deliver the full diversity and functionality of the microbiome. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spearhead microbiome treatment integration into clinical practice.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191207005042/en/

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MaaT Pharma Announces the Presentation of Positive Data with Its Lead Microbiome Biotherapeutic in Intestinal-Predominant Acute...

Its that time of year again an avalanche of ads urging us to drool into tubes so companies can spit back verdicts on our pasts, presents, and futures. Judging from my emails, those unceasing ads have inspired many questions about genetics in general.

Among the emails that pinged in recently:

So I started a list of my e-mails, with apologies to Hillary, and extracted three recurring themes: transgender identity, when a human life begins, and by far the largest group: interpreting DNA test results, either consumer or clinical.

What do you think about a new studythat found 20 genetic markers of transgender identity? asked a reporter from The Times of London In March 2018. Id suggested just such a study a year earlier, which hed found here.

Impressed with the study, I agreed to comment. But the reporter forgot to distinguish me from the researcher, and so throughout Europe, I was suddenly an expert on transgender genes. And that inspired some telling emails.

The first, from a trans woman born in 1948, shared her 70-page story:

As far back as I can remember I thought nothing of going into my mothers closet, pulling down her nightgowns, and putting them on. They were soft, they smelled of her, and they felt so perfect. This was me. Everything feminine fascinated me. Anything male repelled me. I wanted to emerge myself in the female world. But no matter what I did, I just couldnt look like Mommy.

Another transgender woman wrote:

I would love to have that degree of certainty that a genetic study would show. Parents would be able to perhaps work with their children instead of ignoring it either intentionally or out of ignorance.

A recent email from 58-year-old Edith brought up nature v nurture:

Two of my nine nieces and nephews are transitioning. My family has an overall fluid concept of gender identity, which we discussed with each other before either child made it known they were trans. I find myself wondering if this is true in other families.

Me too.

I repost 17 timepoints whenever womens reproductive rights are threatened, or I read or hear a comment that indicates ignorance of biology. The idea of the list came to me when considering that an embryos genome turns on at day 5, but it cant possibly exist at that point outside of a womans body.

One woman asked about fetal rights. Her ex had given her an herbal abortion tea without her knowledge when she was pregnant. Her baby so far is healthy, but she wants a court to recognize the tea-poisoning as child abuse. At what point in utero does a fetus have rights? It seems to vary state to state, she wrote.

Celia Collias, a statistics major at the University of North Carolina, offered a compelling perspective: distinguishing two types of viability. Natural ability to be physiologically independent for a human fetus is around 24 weeks. Technologically assisted viability for a human fetus is 21 weeks.

If we dont use natural viability as the cut off for reproductive rights, Ms. Collias argues, then those rights will erode as technology sets back the age of assisted viability:

Technologically assisted viability is not free. If we allow that to be the benchmark, its going to cost society a lot to care for all those fetuses where would that money come from?

Good question.

Is he really my brother? asked the woman who sent me scanned columns of genetic markers. I circled 16 of 38 that they share and sent it back: Yes.

I dont have mutations in BRCA1 or 2, so Im ok, right? I do have a mutation in ATM (or p53 or CHEK2 or PTEN or RAD51 or a few dozenothers). Inherited mutations for cancer risk go beyond the most common ones in the BRCA pair, and altogether they account for only 5 percent of cases. Yes, shes at high risk.

BRCA brings up the limited variant problem. Consumer DNA tests, for cancer or single-gene diseases, are likely to check for only the most common variants, such as a handful of mutations in the CFTR gene behind cystic fibrosis, which has more than 1,700. These health reports may provide a false sense of reassurance and should not be used for making any health decisions without confirmation testing, said Edward Esplin, MD, of Invitae, a clinical testing company, at the American Society of Human Genetics conference in October, catalyzing a flood of headlines.

I had a prenatal screen for 125 genes and one is a variant of uncertain significance. What the heck is a VUS? Do I have a mutation or not?

A VUS is a gene variant that isnt common, but hasnt shown up in someone with a disease and reported in the medical literature. Yet. I explain here.

My ethnicity estimate changed overnight. Huh? When an ancestry company adds a new group to its database of reference populations, the sections of those pie charts can shift, or a new one appear.

Im 20 weeks pregnant. The fetus has a microduplication of chromosome 18. Is that a problem? The healthy dad-to-be also had the tiny extra bit of DNA. So, no.

I just found out that I have an extra Y chromosome. Ive had severe acne since my early teens, and today Im 62 and weigh 295 pounds. Im a biker, football player, and served time for selling pot. Did my extra chromosome get me arrested?

Probably not. Being in the wrong place at the wrong time, before decriminalization, was more likely at fault.

Because most of my email brings up medical matters, heres a short guide to getting help in making sense of DNA test results related to health. (For interpreting ancestry findings, the International Society of Genetic Genealogy is an excellent resource.)

Its important to distinguish consumer DNA tests, which anyone can take by purchasing a kit and spitting or swizzling a cheekbrush, from clinical DNA tests, which a health care provider orders and the FDAs Clinical Laboratory Improvement Amendments (CLIA) regulate.

Like mushrooms materializing after a warm rain, articles, websites, books and companies are springing up to help consumers navigate test-taking and interpretation.

Finding an expert specifically trained at the graduate level in genetics a genetic counselor, PhD geneticist, or MD with genetics/genomics training is challenging because their priorities are in clinical testing, not the entertainment/education space that the consumer companies so ceaselessly promote. Other scientists may be helpful molecular biologists, biochemists but genetics as a discipline transcends DNA, including developmental, transmission, and population and evolutionary genetics too. Ancestry testing in particular melds these levels of genetics.

Assuming a sit-down with an expert to intrepret consumer DNA data isnt happening easily, here are some places to turn.

A longstanding helpful website is Genetics Home Reference, from the NIH.

A newer resource is this report from ConsumersAdvocate.org. Their researchers recently sent DNA anonymously to 9 leading consumer DNA testing companies, interpreted the data, and then wrote a detailed, clear analysis that compares the services, privacy/security measures, online resources, and cost of tests.

Consumer DNA testing is a fast-growing industry with over 26 million users worldwide. That number is expected to grow to 100 million by 2021, Sam Klau, Community Outreach at the organization, told me.

An excellent new book is DNA Nation: How the Internet of Genes is Changing Your Life, by PhD molecular biologist Sergio Pistoi. And my human genetics textbook will be out in a new edition in September. Ive added a chapter called The Genetics of Identity, inspired by having my past rewritten recently thanks to ancestry testing.

The testing company websites, like that of 23andme, provide clear and well-written info on interpreting test results. But without any prior knowledge of genetics, misinterpretation and misplaced angst can arise.

Does the average person know the difference in significance between revealing a pattern of genome-wide single-base variations (SNPs) associated with elevated risk of a trait or illness, and detecting a well-studied mutation in a single gene?

The raw data dump from consumer DNA testing can be overwhelming, and to paraphrase Elizabeth Warren: Theres a company for that. A consumer can pay to avoid bushwhacking through dense SNP forests.

Strategene, for example, is a genetic reporting tool that uses 23andMe data to identify SNPs in a few dozen well-studied, health-related genes, and not every SNP under the sun. The $45 is a sound investment; it would take hours to sort through Google Scholar to DIY. But the client needs to know about the limited variant issue of checking only for common SNPs.

(I was briefly fooled into confusing the company with 1980s biotech giant Stratagene, but its off by one letter and one capitalization. The only person named on the company website is a naturopath referred to many times as Dr., which wouldnt necessarily denote a genetics expert.)

Im curious to see how soon the medical profession catches up. Right now, genetic counselors in the US number only about 5,000. But professional organizations are stepping in. The American College of Medical Genetics and Genomics, for example, offers online continuing medical education, ACMG Genetics 101 for Healthcare Providers.

But doctors Ive encountered recently still go deer-in-the-headlights when I ask a genetics question, just to be obnoxious. And so a company like ActXmakes sense in helping medical professionals keep pace with the growing tide of patients coming in waving consumer DNA test results. The company helps physicians and patients apply 23andMe raw data to select drugs, order clinical tests to help diagnose specific conditions, and to confirm carrier status for single-gene diseases.

When I started my career as a Drosophila geneticist, mutating flies to grow legs out of their heads, I never imagined at-home DNA testing. When I started my career as a science writer and textbook author, I still couldnt have predicted at-home DNA testing. Now that its here, Im thrilled that DNA science has become so much more tangible and practical. Yet we must use the information in our strings of A, C, T, and G wisely.

Ricki Lewis is the GLPs senior contributing writer focusing on gene therapy and gene editing. She has a PhD in genetics and is a genetic counselor, science writer and author of The Forever Fix: Gene Therapy and the Boy Who Saved It, the only popular book about gene therapy. BIO. Follow her at her website or Twitter @rickilewis

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Does the 'genetics revolution' unsettle you? Here is a guide, and reasons to be hopeful - Genetic Literacy Project

GLEN MILLS, Pa., Dec. 10, 2019 /PRNewswire/ --SmartSolutions RX, Inc. announces the launch of a new scientifically based, drug-free hair support system LOCKrx, which includes both ingestible and topical Healthy Hair Programs that create the ideal environment to maintain hair follicle cycle and growth.

Hair thinning and hair loss are a pervasive problem, affecting an estimated 80 million men and women in the U.S. Smoking, diet, stress, environment and genetics all contribute to hair loss, as well as the hormone DHT which shrinks the hair follicle and is the primary cause of loss in male and female pattern baldness. The current treatments often come with unwanted side effects and take months to generate results.

LOCKrx is a drug-free hair treatment system that addresses scalp health, both internally and externally, that directly impacts hair growth and quality.

"When formulating LOCKrx, we meticulously designed and tested both ingestible and topical ingredients that are scientifically proven to reduce the inflammation associated with damaged hair follicles and thereby improve quality of the hair," said Cynthia Rager, President and COO of Vision Medical, Inc. "Our topical LOCKrx solutions include specific growth factors clinically shown to play a key role in the hair follicle growth pathway as well as to enhance wound repair and skin regeneration, all of which improve scalp skin health, while also playing a vital role in the proliferation of skin and hair cells."

LOCKrx is available as both internal and external treatment plans, designed to work synergistically to promote healthy scalp skin and hair growth.

"Growthfactors possess the ability to stimulate hair growth through variousmechanistic pathways," said Richard Jin, M.D., Ph.D., Hair Regeneration Specialist, RJClinical Institute. "We have experienced very positive results when combiningthese with platelet rich plasma therapy to promote new and existing hairgrowthas well as using it as an alternative to PRP. This has helped us treat the mostcommon form of hair loss known as androgenetic alopecia, as well as increasethickness and density of hair in post-transplant patients."

LOCKrx Inside Healthy Hair Programis a 3-step, 6-week ingestible plan that uses unique marine and botanical ingredients, amino acids, and vitamins to address total body inflammation.

1. DEFENSE Gut Health - Prebiotic supplement that includes mineral-rich blue green algae and proven anti-inflammatory botanicals curcumin, aloe, licorice and beta-glucan to address gut health in powdered form.

2. BLOCK Hair Loss- Follicle-enrichment supplement formulated with the LOCKrx proprietary blend of botanicals, adaptogens, marine collagen, and saw palmetto to help support hair growth and block conversion of testosterone to DHT, one of the major causes of hair loss in male and female pattern baldness.

3. GUARD Healthy Hair Tabs- Premier blend of complexed Vitamin B plus biotin in the most bio-available form.

LOCKrx Outside Healthy Hair Programis a combination of clinical and at-home applications of growth factor solutions that support and balance the scalp microbiome, while enhancing the environment for healthy hair growth:

VisionMedical, Inc. has exclusive physician distribution rights for LOCKrx.

Smart Solutions RX, Inc.

Smart Solutions RX, Inc. formulates, develops, manufactures and distributes products for medical aesthetic applications to hair and skin. A blend of scientific research and innovative formulation and delivery systems are the hallmark, as evidenced in the LOCKrx brand for healthy hair support. Medical aesthetic protocols and workshops are integrated into the superior customer support program. http://www.smartsolutionsrx.com

Vision Medical, Inc.

Founded in 2013, VisionMedical, Inc. develops, manufactures, and marketsmedical and aesthetic technology for the medical and aesthetic marketsfor worldwide distribution.Vision Medical's first commercial product, theSmartGraft Hair Restoration System, incorporates an award-winning Automated Follicular Unit Extraction (FUE) system for men and women.Featuring theindustry's first closed harvesting system, SmartGraft allows physicians to harvestgrafts more efficiently while keeping grafts moist prior to implantation. http://www.SmartGraft.com.

CONNECT WITH US

Instagram: @SmartSolutionsRXTwitter: @SSolutionsX Facebook: @SmartSolutionsRXinc

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SmartSolutions RX Launches LOCKrx, A Drug-Free Support System Fighting To Keep Hair Thick and Healthy - P&T Community

(Reuters Health) - Babies who are born too early may be more likely to develop diabetes as children and young adults than full-term infants, a new study suggests.

In a study of children up to age 18, those born before 37 weeks gestation were 21% more likely that those born at full term to develop type 1 diabetes, the less common form of the disease that typically appears in childhood or young adulthood. Kids born prematurely were also 26% more likely to develop type 2 diabetes in childhood.

And preemies were 24% more likely to develop type 1 diabetes and 49% more likely to develop type 2 diabetes by the time they were 43 years old.

Preterm birth interrupts normal development of multiple organ systems, including the pancreas where insulin-producing cells are formed, which may potentially contribute to later development of diabetes, said lead study author Dr. Casey Crump of the Icahn School of Medicine at Mount Sinai in New York City.

Pregnancy normally lasts about 40 weeks, and babies born after 37 weeks of gestation are considered full-term. Babies born prematurely - earlier than 37 weeks - often have difficulty breathing and digesting food in the weeks after birth. Preemies can also encounter longer-term challenges such as impaired vision, hearing and cognitive skills, as well as social and behavioral problems.

Some previous research suggests that preemies have an increased risk of developing so-called insulin resistance, a failure to respond normally to the hormone insulin.

In type 1 diabetes, the pancreas cant produce insulin. In the type 2 form of the disease, which is often linked to obesity and aging, the body cant properly use or make enough insulin to convert blood sugar into energy.

For the current study, researchers examined data on almost 4.2 million babies born in Sweden from 1973 to 2014. Most were followed until they were at least 22 years old.

Overall, 0.7% of the babies in the study population went on to develop type 1 diabetes and just 0.1% developed type 2 diabetes, the researchers report in Diabetologia.

Parents should know that most children who were born preterm will have good health in childhood and adulthood, Crump said by email. However, they also have modestly increased risks of diabetes that persist into adulthood.

Overall, the risk tended to be higher for preemie girls. Boys who arrived early were about 20% more likely to develop type 1 diabetes during the study, while girls had about a 30% greater likelihood.

With type 2 diabetes, female preemies were 60% more likely to develop this disease during childhood than full-term babies, while preemie males didnt have an increased risk. For young adults in the study, women who were preemies had a 75% increased risk of type 2 diabetes and men who were preterm had a 28% increased risk.

Many people in the study had siblings included in the analysis. Shared genetics and family circumstances appeared to explain some, but not all, of the increased risk of diabetes for preemies.

The study wasnt designed to prove whether preterm birth influences susceptibility to diabetes.

Even so, the results underscore that preemies need to take steps to prevent diabetes later in life, said Ciaran Phibbs of the VA Palo Alto Health Care System and Stanford University School of Medicine in California.

The home environment is an important factor, especially for type 2 diabetes, Phibbs, who wasnt involved in the study, said by email. This includes things like diet and exercise habits, which can impact the risk of obesity, which is higher for preemies than for full-term babies and is a risk factor for diabetes, he said.

Individuals who were born preterm can help prevent diabetes by following a healthy lifestyle across the life course, including a healthy diet, regular physical activity, and maintaining a normal weight, Crump advised.

SOURCE: bit.ly/2LCQrpq Diabetologia, online December 3, 2019.

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Preemies face higher risk of diabetes as children and young adults - Reuters

Only recently have scientists applied such techniques to bringing endangered wildlife species back from the brink of extinction.

December 8, 2019 by EarthTalk Leave a Comment

By Doug Moss and Roddy Scheer

Dear EarthTalk: Can fertility techniques pioneered for humans or other animals be used to try to bring back endangered wildlife species?

James E., Richmond, VA

No doubt, humans have come a long way in engineering medical solutions to our own fertility problems. The most common techniques to help people have babies today include: using medication to stimulate unresponsive ovaries to develop mature eggs; artificial insemination whereby healthy sperm is placed directly into a womans uterus and conception happens normally thereafter, and In Vitro Fertilization (IVF), which entails combining eggs and sperm outside the body and then inserting one of the resulting fertilized embryos (so-called test tube babies) into the womans uterine cavity and letting the rest of the pregnancy proceed to term naturally.

While such techniques have helped millions of couples around the world bear healthy babies, only recently have scientists applied such techniques to bringing endangered wildlife species back from the brink of extinction. The genetics of human fertility can give a better understanding of fertility in more exotic species, reports Dr. Sherman Silber, a pioneering human fertility expert at St. Lukes Hospital in Chesterfield, Missouri who has had success applying the lessons learned on humans to animals.

To date, Silber and his colleagues have helped a half dozen leading U.S. zoos maintain healthy populations of chimpanzees, gorillas, South American bush dogs, Mexican wolves, orangutans and Mongolian wild horses using surgical techniques, artificial insemination, IVF and gestational surrogacy (whereby another female besides the genetic mother carries the pregnancy to term).

We have frozen ovaries in animals that are destined to die off for later ovary transplantation back to related species to be able to increase their population, reports Silber, who has of late been ramping up efforts to bring back dwindling populations of still-wild endangered species.

Another leading light in the field is Thomas Hildebrandt, who heads the reproduction management program for Berlins Leibniz Institute for Zoo and Wildlife Research and is well known among wildlife veterinarians for his pioneering work in endangered species insemination. Hildebrandt, who helped conceive upwards of 50 endangered elephant calves by artificially inseminating their mothers is now focusing his attention on trying to rescue the Northern White Rhino using IVF techniques. Rampant poaching in the 1970s and 1980s and surging demand in Asia for rhino horns decimated the animals populations in Africaonly two individuals, Fatu and Najin (both female and incapable of carrying babies due to health complications) remain alive today; the last male, Sudan, died in March 2018.

Now Hildebrandt and colleagues want to bring them back. They froze the sperm from Sudan and four other males before they died and hope to combine it with eggs harvested from Fatu and Najin while using less endangered but genetically similar Southern White Rhino females as pregnancy surrogates. While this baby step wont be enough to achieve the genetic diversity required to create a sustainable long-term population, Hildebrandt hopes it can open funders eyes to the possibility of actually reviving populations of Northern White Rhinos and other species through stem cell research and other techniques researchers havent even dreamed up yet.

This post was previously published on earthtalk.org and is republished here with permission from the author.

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In Vitro Fertilization To The Rescue For Endangered Species Fertility - The Good Men Project

Another set of female innovation leaders are making headlines as we move into another week of innovators to know.

This week's set of who's who include a startup founder trying to change the world, a passionate PhD with a story of failure to tell, and a biomedical engineer enhancing health tech in Houston.

A Houston mom is working hard on her startup so that next summer, breastfeeding moms can swim in style and worry free. Courtesy of Orolait

On the surface, it may seem that Houston mom Ana Carolina Rojas Bastidas has a passion for fashion, as she's created and is fundraising for a new-mom specific line of swimwear. But really, she's on a mission to give breastfeeding women back their dignity with her startup, Orolait.

"I decided to build this company to challenge and change the way we depict one's breastfeeding journey," Bastidas says on the website. "I stand on the pillars of advocacy, education, and inclusion. You will see the sizing and advertising featuring all shapes, sizes, and shades because each of us is so different and that is what makes us so incredible and I am going to unapologetically celebrate that in the most ethical way I know how." Read the story.

Brittany Barreto founded the first nationwide DNA-based dating app, and she shares her story of its unexpected, and unavoidable, downfall. Photo courtesy of Pheramor

After dedicating three long years to her startup that began as an idea in college, Brittney Barreto is saying goodbye to Pheramor. Barreto explains how her DNA-based dating app got pulled from the Apple app store following policy changes, and how it left her with no choice but to shutter the operation.

Now, Barreto has big plans for funding femtech, and is learning a lot in her new role at Capital Factory. She's already able to do more for other founders and create a bigger impact.

"I realized that over the past two years, I had already been ad hoc coaching and mentoring founders and loving it," Barreto says. "Now, I was doing it and getting paid for it, on a bigger scale, and with more resources. I knew it was the journey I wanted to continue down." Read the full story.

From robots and accelerator programs to her favorite health tech startups, Emily Reiser of the TMC Innovation Institute joins the Houston Innovators Podcast. Photo courtesy of Emily Reiser

Emily Reiser has known for most of her life that she's wanted to work in health tech in some capacity. On the Houston Innovators Podcast, she explains how she combined her early interest in health care with her affinity with engineering inspired by her parents.

Now, she continues to check both those boxes at the Texas Medical Center's Innovation Institute, which has evolved a ton over the past year.

"In 2019, we had a lot of big changes around our team and our leadership," she says on the podcast. "That enabled us to take a bigger breath and a bigger pause to say, 'How are we really doing? And how could we be doing better?'" Read the full story and stream the podcast.

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3 Houston female innovators to know this week - InnovationMap

"These guidelines are as inclusive as possible, wherever there's strong, unbiased evidence to back up our recommendations," said Mary B. Daly, MD, PhD, FACP, Fox Chase Cancer Center, Chair of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "The guidelines include genes that have been found to increase cancer-susceptibility. These NCCN Guidelines still have a strong focus on BRCA1 and 2 mutations, but also now include other high and moderate penetrance genes associated with breast, ovarian, and pancreatic cancer. We continuously review any new data on genes that might increase a person's risk of getting cancer or impact the effectiveness of their treatment."

The updated guidelines are concentrated around simplified criteria to clarify the genetic testing process. For example, in a newly-added guide for individuals of Ashkenazi Jewish ancestry who have not been diagnosed with cancer, genetic testing may be offered for the three Ashkenazi Jewish founder mutations in the context of a long-term research study, regardless of family history. These individuals should be encouraged to consult with a cancer genetics professional.

The NCCN Guidelines for Genetic/Familial High-Risk Assessment are organized by both disease and syndrome type, and also now include streamlined information on appropriate subsequent steps for persons who meet criteria for genetic testing. The panel acknowledges that genetic mutations can impact the approach to cancer treatment, and the guidelines now state that testing may be clinically indicated if it will aid in systemic therapy decision-making.

"Genetic testing is becoming increasingly utilized in oncology because of its potential to impact surgical decisions and chemotherapy," explained Robert Pilarski, MS, LGC; MSW, Licensed Genetic Counselor, Professor, Clinical Internal Medicine, The Ohio State University Comprehensive Cancer Center, Vice-Chair of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "At the same time, the complexity of this testing is increasing, with a growing number of genes and tests available,a limited understanding of the management implications of some of the newer genes, and even uncertainty over the implications of mutations in well-established genes in some situations (for example in a condition known as 'mosaicism,' in which the mutation is not present in all of the cells of the body). Because of this, the NCCN Guidelines continue to highlight the critical importance of genetic counseling for patients prior to undergoing genetic testing to ensure that patients are fully informed of the test implications."

Pilarski also offered an important word of caution about the potential risks from direct-to-consumer genetic testing: "More and more patients are presenting to clinic having already had themselves tested through direct-to-consumer labs. Providers need to be aware that the tests offered by many of these labs are not equivalent to traditional genetic testing, and the results may need to be confirmed in another laboratory before being used for clinical care."

The guidelines recommend all pancreatic cancer patients get genetic testing, and the recent update now includes more information about which genes are associated with pancreatic cancer recommendations. Genetic testing in pancreatic cancer can help determine which treatments would be most effective (e.g. PARP inhibitors) and if family members would benefit from screening and preventive action.

"There's been an explosion of recent data showing that roughly 4-10% of individuals with pancreatic cancer harbor inherited genetic mutations, including BRCA1, BRCA2, ATM, the Lynch syndrome genes, and others," said Matthew B. Yurgelun, MD, Dana-Farber/Brigham and Women's Cancer Center, Member of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "Such data have, surprisingly, shown that classic 'high-risk' features of inherited cancer risk (e.g. young age at diagnosis, strong family histories of cancer) are often absent in individuals with pancreatic cancer who carry these mutations. Based off of these data, there is now a compelling reason for all individuals with pancreatic cancer to be offered genetic counseling and germline testing for such variantsparticularly given the possibility that their at-risk family members could greatly benefit from known, effective cancer risk-reducing interventions (e.g. surgical removal of the ovaries for female BRCA1/2 mutation carriers). Emerging data have also begun to suggest possible benefits to pancreatic cancer screening in select high-risk individuals who harbor such mutations. These new guidelines address many of the important nuances and limitations of this exciting and rapidly evolving body of literature."

The NCCN Guidelines for Genetic/Familial High-Risk Assessment are created and maintained by an interdisciplinary panel of experts from the alliance of 28 leading cancer centers that comprise NCCN. NCCN panels also include patients and advocates to make sure treatment recommendations meet the needs of people with cancer and their caregivers.

"Participating on the NCCN panel allows FORCE to share the real-world experiences of patients making complex, and often agonizing medical decisions about hereditary cancer treatment and risk management," said Sue Friedman, DVM, Executive Director, Facing Our Risk of Cancer Empowered (FORCE), Member of the NCCN Guidelines Panel for Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic. "As an advocacy organization for people and families affected by hereditary cancer, we see the importance of having standardized guidelines. These guidelines are a critical piece of informed decision-making; we frequently direct our community to NCCN for up-to-date, clear, and credible information developed by experts in the field."

NCCN Guidelines are the recognized standard for clinical policy in cancer care and are the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer careincluding physicians, nurses, pharmacists, payers, patients and their familieswith the ultimate goal of improving patient care and outcomes. In addition to covering at least 97 percent of cancers affecting patients in the United States, there are also NCCN Guidelines for detection, prevention, risk-reduction (including smoking cessation), supportive care (including the management of pain, distress, and fatigue), and guidelines for specific populations (including children and young adults).

NCCN Guidelines are available free-of-charge for non-commercial use at NCCN.org, or via the Virtual Library of NCCN Guidelines App.

About the National Comprehensive Cancer NetworkThe National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of 28 leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. Through the leadership and expertise of clinical professionals at NCCN Member Institutions, NCCN develops resources that present valuable information to the numerous stakeholders in the health care delivery system. By defining and advancing high-quality cancer care, NCCN promotes the importance of continuous quality improvement and recognizes the significance of creating clinical practice guidelines appropriate for use by patients, clinicians, and other health care decision-makers around the world.

The NCCN Member Institutions are: Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA; Fred & Pamela Buffett Cancer Center, Omaha, NE; Case Comprehensive Cancer Center/University Hospitals Seidman Cancer Center and Cleveland Clinic Taussig Cancer Institute, Cleveland, OH; City of Hope National Medical Center, Duarte, CA; Dana-Farber/Brigham and Women's Cancer Center | Massachusetts General Hospital Cancer Center, Boston, MA; Duke Cancer Institute, Durham, NC; Fox Chase Cancer Center, Philadelphia, PA; Huntsman Cancer Institute at the University of Utah, Salt Lake City, UT; Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance, Seattle, WA; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL; Mayo Clinic Cancer Center, Phoenix/Scottsdale, AZ, Jacksonville, FL, and Rochester, MN; Memorial Sloan Kettering Cancer Center, New York, NY; Moffitt Cancer Center, Tampa, FL; The Ohio State University Comprehensive Cancer Center - James Cancer Hospital and Solove Research Institute, Columbus, OH; O'Neal Comprehensive Cancer Center at UAB, Birmingham, AL; Roswell Park Comprehensive Cancer Center, Buffalo, NY; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine, St. Louis, MO; St. Jude Children's Research Hospital/The University of Tennessee Health Science Center, Memphis, TN; Stanford Cancer Institute, Stanford, CA; UC San Diego Moores Cancer Center, La Jolla, CA; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; University of Colorado Cancer Center, Aurora, CO; University of Michigan Rogel Cancer Center, Ann Arbor, MI; The University of Texas MD Anderson Cancer Center, Houston, TX; University of Wisconsin Carbone Cancer Center, Madison, WI; Vanderbilt-Ingram Cancer Center, Nashville, TN; and Yale Cancer Center/Smilow Cancer Hospital, New Haven, CT.

Clinicians, visit NCCN.org. Patients and caregivers, visit NCCN.org/patients. Media, visit NCCN.org/news. Follow NCCN on Twitter @NCCN, Facebook @NCCNorg, and Instagram @NCCNorg.

Media Contact: Rachel Darwin267-622-6624darwin@nccn.org

SOURCE National Comprehensive Cancer Network

http://www.nccn.org

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As the total number of e-cigarette and vaping-related injuries (EVALI) reaches2,291 across all 50 states, researchers in California are unveiling a new potential danger of vaping: cobalt lung.

The news comes from acase studypublished in the European Respiratory Journal this week which focuses on a 49-year-old woman in California who developed the rare disease after vaping for just six months. The woman, a dog trainer by trade, sought out medical help when she began experiencing symptoms like shortness of breath and coughing which aligned with the pneumonia-like cases of EVALI.

Although doctors initially thought she may have had vaping illness, the womans lungs showed something else, the distinct scarring of lung tissue that is typically only seen in those who work with hard metals. The condition technically known hard-metal pneumoconiosis is a rare but serious disease of the lungs associated with inhalational exposure to tungsten or cobalt dust, according to the NIH.

After observing her lung tissue, the researchers from the University of California, San Francisco performed tests on her vaping product, which contained the hard metal cobalt, among others. In a statement released to reporters, the researchers expressed shock at the development.

"Exposure to cobalt dust is extremely rare outside of a few specific industries, Rupal Shah MD, assistant professor of medicine in the division of pulmonary, critical care, allergy, and sleep medicine at the University of California, San Francisco,said. This is the first known case of a metal-induced toxicity in the lung that has followed from vaping and it has resulted in long-term, probably permanent, scarring of the patient's lungs.

In an interview with Yahoo Lifestyle, Kirk Jones MD, clinical professor of pathology at the University of California, San Francisco said hes only seen three previous cases of cobalt lung in his entire career, including one involving a sawmill worker and another in a dental worker. Its always been kind of a work-related disease so it was peculiar in this patient because they didnt have any exposures that we knew of, Jones tells Yahoo Lifestyle. Until we tested the vaping device.

The vaping device the woman was using, called the ZenPen, was found to have e-cigarette liquid containing nickel, aluminum, manganese, and lead and a metal coil used to heat the liquid. As a result of inhaling this, Jones says the white airspaces of the lung that allow oxygen to flow had been filled up with inflammatory cells.

She had less room in her lungs to breathe, says Jones. The woman was reportedly treated with steroids and has regained half of the function she lost in her lungs, but will likely have permanent scarring.

Jones says EVALI and cobalt lung develop differently. With the EVALI cases, patients suffer an acute collapse and damage of the lung that comes on pretty quickly, probably over a few hours, he explains. Whereas our case is more of an immune reaction. It's kind of an allergic reaction...to the metal found in people who are susceptible to cobalt and the disease would develop over the course of weeks or months.

The researchers are spreading the word about the case of cobalt lung in part because they fear its not the only one. I think that cobalt is probably in a lot of these e-cigarettes, says Jones. Maybe a small percentage of patients that use them will end up with the disease and probably already have, but it hasn't been recognized yet.

Related Video: It Is Not Harmless: Dentists Voice Concern Over Vaping

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Woman's e-cigarette habit leads to her 'cobalt lung' diagnosis an incurable disease found only in metal workers - Yahoo Lifestyle

Four-Year Data Continue to Show Superior Progression-Free Survival of ADCETRIS in Combination with AVD when Compared to ABVD in Frontline Advanced Hodgkin Lymphoma with 31 Percent Reduction in the Risk of Progression or Death

Additional Analysis from ECHELON-2 Phase 3 Clinical Trial Evaluating ADCETRIS Plus CHP Chemotherapy Also Featured at ASH Annual Meeting

BOTHELL, Wash. & CAMBRIDGE, Mass. & OSAKA, Japan Seattle Genetics, Inc. (Nasdaq:SGEN) and Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced additional analyses of results from the ECHELON-1 and ECHELON-2 frontline phase 3 trials of ADCETRIS (brentuximab vedotin). These analyses were presented at the 61st Annual Meeting of the American Society of Hematology (ASH) taking place December 7-10, 2019 in Orlando, Fla. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma and expressed on the surface of several types of peripheral T-cell lymphomas (PTCL).

The ECHELON-1 analysis highlighted a four-year update of the phase 3 clinical trial in a poster presentation. ECHELON-1 is evaluating ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) compared to ABVD (Adriamycin [doxorubicin], bleomycin, vinblastine and dacarbazine) in patients with Stage III or IV frontline classical Hodgkin lymphoma.

The ECHELON-2 phase 3 clinical trial data were presented in an oral session at ASH and focused on the outcomes of the subset of patients who underwent consolidative stem cell transplant. ECHELON-2 is evaluating ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) compared to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in frontline CD30-expressing PTCL.

For decades, the standard of care for the treatment of frontline Hodgkin lymphoma has been combination chemotherapy, called ABVD. Unfortunately, approximately 30 percent of patients with advanced stage Hodgkin lymphoma do not respond or relapse following treatment with this therapy, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. The four-year update from the ECHELON-1 trial continues to support the robust and durable frontline treatment benefit of ADCETRIS plus AVD, including in both Stage III and IV disease settings, compared to ABVD across subgroups, regardless of PET2 status. These data reinforce ADCETRIS plus AVD as a treatment option that should be offered to all newly diagnosed advanced stage patients with Hodgkin lymphoma.

Updated data from the ECHELON-1 trial and further insights from ECHELON-2 build upon our continued understanding of the potential ADCETRIS offers patients with CD30-positive lymphomas, said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. Were especially encouraged by the promising four-year follow-up ECHELON-1 results being presented at ASH, as approximately one in three patients with advanced Hodgkin lymphoma do not achieve long-term remission after standard frontline therapy.

Brentuximab Vedotin with Chemotherapy for Stage 3/4 Classical Hodgkin Lymphoma (cHL): 4-Year Update of the ECHELON-1 Study (Abstract #4026, poster presentation on Monday, December 9, 2019)

As previously reported, the ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified progression-free survival (PFS) compared to the control arm of ABVD as assessed by independent review facility (IRF; hazard ratio (HR), 0.77; p=0.035). A four-year post-hoc exploratory analysis was conducted to examine PFS outcomes per investigator assessment in the intent-to-treat population of 1,334 patients, including results by PET2 status, age, stage and prognostic risk scores. Results include:

More than 45 countries and regions have approved ADCETRIS in combination with AVD for the treatment of patients with previously untreated Stage III or IV Hodgkin lymphoma. The U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical Hodgkin lymphoma in March 2018, based on the results of the ECHELON-1 phase 3 clinical trial in which the primary endpoint was modified PFS. In February 2019, the European Commission (EC) approved ADCETRIS for the treatment of adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma in combination with AVD.

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-Cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant (Abstract #464, oral presentation on Sunday, December 8, 2019)

As previously reported, the ECHELON-2 trial met its primary endpoint with the combination of ADCETRIS plus CHP resulting in a statistically significant improvement in PFS versus the control arm of CHOP per blinded independent central review (HR, 0.71; p=0.0110). In addition, the overall survival benefit in the ADCETRIS plus CHP arm was statistically significant compared to CHOP (HR, 0.66; p=0.0244). A post-hoc exploratory analysis evaluated the impact of consolidative stem cell transplant in the ECHELON-2 study for the patients who achieved CR treated with ADCETRIS plus CHP. In the ADCETRIS plus CHP arm, this included 38 patients in CR who received a stem cell transplant and 76 patients in CR who did not. Key findings of this analysis include:

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,110 cases of Hodgkin lymphoma will be diagnosed in the United States during 2019 and 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About Seattle Genetics

Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) utilizes the companys industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has a late-stage pipeline including enfortumab vedotin for metastatic urothelial cancer, currently being reviewed for approval by the FDA, and tisotumab vedotin in clinical trials for metastatic cervical cancer, which utilize our proprietary ADC technology. In addition, tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer and in clinical development for metastatic colorectal cancer. We are also leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in peoples lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries.

For more information, visit https://www.takeda.com

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer antihyperglycemic medications as clinically indicated.

Most Common (20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here.

ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.

Closely monitor patients for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established Hold dosing for any suspected case of PML and permanently discontinue ADCETRIS if a diagnosis of PML is confirmed.

Be alert to PML symptoms that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Closely monitor patients for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. Hold ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. Promptly evaluate and treat new or worsening pulmonary symptoms (e.g., cough, dyspnoea) appropriately. Consider holding dosing during evaluation and until symptomatic improvement.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Carefully monitor patients during treatment for emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Carefully monitor patients during and after an infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an IRR occurs, interrupt the infusion and institute appropriate medical management. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. Monitor these patients closely and manage according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically an effect of cumulative exposure to ADCETRIS and is reversible in most cases. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Monitor complete blood counts prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Closely monitor patients for fever and manage according to best medical practice if febrile neutropenia develops.

When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients beginning with the first dose.

Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. Discontinue treatment with ADCETRIS if SJS or TEN occurs and administer appropriate medical therapy.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, have been reported with ADCETRIS. Promptly evaluate and treat patients if new or worsening GI symptoms occur.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Test liver function prior to treatment initiation and routinely monitor during treatment. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Closely monitor serum glucose for patients who experiences an event of hyperglycemia. Administer anti-diabetic treatment as appropriate.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations.

CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Szary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Carefully consider the benefit-risk per patient and use with caution in other CD30+ CTCL patient types.

Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

INTERACTIONS

Patients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia. If neutropenia develops, refer to dosing recommendations for neutropenia (see SmPC section 4.2). Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS, but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.

PREGNANCY: Advise women of childbearing potential to use two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. Do not use ADCETRIS during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus.

LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.

FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Advise men being treated with ADCETRIS not to father a child during treatment and for up to 6 months following the last dose.

Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS

Monotherapy: The most frequent adverse reactions (10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was 1%. Adverse events led to treatment discontinuation in 24% of patients.

Combination Therapy: In the study of ADCETRIS as combination therapy with AVD in 662 patients with previously untreated advanced Hodgkin lymphoma, the most common adverse reactions ( 10%) were: neutropenia, nausea, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, alopecia, peripheral motor neuropathy, decreased weight, abdominal pain, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, cough, headache, arthralgia, back pain, dyspnoea, myalgia, upper respiratory tract infection, alanine aminotransferase increased. Serious adverse reactions occurred in 36% of patients. Serious adverse reactions occurring in 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%). Adverse events led to treatment discontinuation in 13% of patients.

Seattle Genetics Forward-Looking Statements

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of ADCETRIS for patients with previously untreated stage III or IV classical Hodgkin lymphoma and patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL). Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to factors such as utilization and adoption of the approved treatment regimen by prescribing physicians, competitive conditions including the availability of alternative treatment regimens, the availability and extent of reimbursement, the risk of adverse events and adverse regulatory action. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Takeda Important Notice

For the purposes of this notice, press release means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (Takeda) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, Takeda is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words we, us and our are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Takeda Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takedas future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as targets, plans, believes, hopes, continues, expects, aims, intends, ensures, will, may, should, would, could anticipates, estimates, projects or similar expressions or the negative thereof. Forward-looking statements in this document are based on Takedas estimates and assumptions only as of the date hereof. Such forward-looking statements do not represent any guarantee by Takeda or its management of future performance and involve known and unknown risks, uncertainties and other factors, including but not limited to: the economic circumstances surrounding Takedas global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations; the success of or failure of product development programs; decisions of regulatory authorities and the timing thereof; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the timing and impact of post-merger integration efforts with acquired companies; and the ability to divest assets that are not core to Takedas operations and the timing of any such divestment(s), any of which may cause Takedas actual results, performance, achievements or financial position to be materially different from any future results, performance, achievements or financial position expressed or implied by such forward-looking statements. For more information on these and other factors which may affect Takedas results, performance, achievements, or financial position, see Item 3. Key InformationD. Risk Factors in Takedas most recent Annual Report on Form 20-F and Takedas other reports filed with the U.S. Securities and Exchange Commission, available on Takedas website at: https://www.takeda.com/investors/reports/sec-filings/ or at http://www.sec.gov. Future results, performance, achievements or financial position of Takeda could differ materially from those expressed in or implied by the forward-looking statements. Persons receiving this press release should not rely unduly on any forward-looking statements. Takeda undertakes no obligation to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results of Takeda in this press release may not be indicative of, and are not an estimate, forecast or projection of Takedas future results.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191209005169/en/

Contacts

Seattle Genetics: Media Monique Greer (425) 527-4641 mgreer@seagen.com

Investors Peggy Pinkston (425) 527-4160 ppinkston@seagen.com

Takeda: Japanese Media Kazumi Kobayashi kazumi.kobayashi@takeda.com +81 (0) 3-3278-2095

Media outside Japan Sara Noonan sara.noonan@takeda.com +1-617-551-3683

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Seattle Genetics and Takeda Announce Additional Analyses of ADCETRIS (Brentuximab Vedotin) ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials at the 2019...

A new study from theNational Institutes of Healthfinds that women who use permanenthairdye and chemical hair straighteners are at a higher risk of developingbreast cancer and the risk is particularly high for black women.

The study, published on Dec. 4 in theInternational Journal of Cancer, looked at hair product use over a 12-month period in more than 46,000 women ages 35-74 all of whom have asisterdiagnosed with breast cancer. The researchers found that permanent hair dye use in black women was associated with a 45 percent higher risk of breast cancer, while white women had a 7 percent higher risk, according to the study.

Using these hair dyes more frequently upped that risk: Black women using permanent hair dye every five to eight weeks or more was associated with a60 percent higher riskof breast cancer, compared to an 8 percent increased risk for white women.

Chemical hair straighteners were also associated with a greater risk of breast cancer. Women who used the treatment every five to eight weeks or more were about 30 percentmore likelyto develop breast cancer; the risk was similar in both black and white women.

Its not entirely clear why breast cancer risk is especially elevated in black women using permanent hair dye. In general, black women have higher rates of the disease than white women before age 40, and are more likely to die from breast cancer at every age, according to theAmerican Cancer Society.

But hair dye alone is likely not at fault. Elizabeth Arena, MD, a surgical oncologist specializing in breast cancer atSurgery Group of Los Angeles, tells Yahoo Lifestyle that there are multiple factors that affect breast cancer risk. It cannot be attributed to one specific cause, so I would not attribute the difference in cancer rates seen in this study to use of hair products alone, Arena says.

She adds: The study did not describe in detail the products that the participants used so it is difficult to fully compare. In theory, different products, with different chemical components, may be designed for people of different racial backgrounds, which could contribute to the different cancer rates, while different hair types may take up the dyes differently as well.

Hair dyes a popular product used by more than one-third of women over age 18 and about 10 percent of men over age 40 contain more than 5,000 different chemicals, some of which are reported to be carcinogenic (cancer-causing) in animals, according to theNational Cancer Institute.

Many hair products contain endocrinedisrupting compounds and carcinogens potentially relevant to breast cancer, the study authorsnoted. Products used predominantly by black women may contain more hormonallyactive compounds.

They added: These results suggest that chemicals in hair products may play a role in breast carcinogenesis.

However, more research is needed to determine which chemicals are problematic. It is very difficult to say if there is a specific chemical in hair dye or hair straighteners that increases the risk of breast cancer, Arena says. This observational study is just a starting point for investigating potential cause and effect. It does not show a direct link at this point, and the study participants did not identify which hair products were specifically used. Past studies in animals have shown concern for ammonia in hair products, whileparabens, which are found in some dyes, are concerning for potential hormonal, estrogen-like effects.

Several studies have looked at possible connections between cancer and hair dye. However, according to theNCI, the research is mixed: Although some studies have linked the personal use of hair dyes with increased risks of certain cancers of the blood and bone marrow, such as non-Hodgkin lymphoma (NHL) andleukemia, other studies have not shown such links. Studies ofbreastand bladder cancer have also produced conflicting results.

Added the NCI: Researchers who reviewed data from 14 studies of female breast cancer and hair dye use published between 1977 and 2002 found that dye users had no increase in the risk of breast cancer compared with nonusers.

That said, the institute also noted that, given the widespread use of hair dye products, even a small increase in risk may have a considerable public health impact.

First, its worth noting that the women in the study all have a family history of breast cancer (a sister diagnosed with the disease), which puts them at a higher risk in general. In many patients, it is related to their genetics and family history rather than environmental exposures, says Arena.

"I think it's important for women, particularly African American women, not to panic every time a study comes out,"Doris Browne, MD, a medical oncologist and former president of the National Medical Association, tellsNPR. "But it should raise questions for our primary care providers."

Arena agrees, adding, Based on this observational study alone, I do not think women should be overly concerned. This study is an interesting starting point for further research, but you cannot draw any final conclusions from a preliminary study like this.

For those who are concerned particularly for women (and men) with a family history of breast cancer they should have a conversation with their primary care physician. For women at higher risk for breast cancer, it is always good to speak with a breast specialist further to discuss your risk factors and lifestyle modifications further, says Arena.

If youre considering stopping the use of permanent hair dyes, the study also found that semi-permanent hair dye, as well as temporary dyes, did not up the risk of breast cancer.

There are also several ways that women can reduce their breast cancer risk namely, maintaining a healthy lifestyle, which is similar health advice to what doctors recommend for other diseases, such as eating a healthy diet, exercising regularly, limiting alcohol intake and reducing stress.

Arena adds, I also strongly recommend regular screening for breast cancer because early detection is the most effective way to treat the disease should it occur.

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Study links permanent hair dye to increased risk of breast cancer, particularly among black women - Yahoo News

Dec. 7, 2019 19:00 UTC

BOTHELL, Wash.--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced updated and long-term follow-up analyses from two clinical trials evaluating ADCETRIS (brentuximab vedotin) and OPDIVO (nivolumab) in frontline Hodgkin lymphoma (HL) patients aged 60 years and older and in relapsed or refractory classical HL. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL. ADCETRIS and OPDIVO are not approved in combination for the treatment of HL. Results were presented today at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla.

We continue to evaluate ADCETRIS in combination with novel therapies, such as checkpoint inhibitors, with the goal of identifying new options for CD30-expressing lymphomas where there is high unmet need, said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. These data presentations at ASH reinforce our strong commitment to the ADCETRIS clinical development program, potentially moving into new patient populations and novel combination treatment strategies.

Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged 60 Years (Abstract #237, oral presentation at 2:30 p.m. ET on Saturday, December 7, 2019) Data were presented from an updated analysis from the phase 2 clinical trial evaluating ADCETRIS in combination with OPDIVO as frontline therapy for HL patients aged 60 years and older. Data were reported from 21 patients, and the median age was 72 years. The majority of patients (76 percent) had stage III/IV disease at the time of diagnosis. These results will be highlighted in an oral presentation by Christopher A. Yasenchak, M.D., Willamette Valley Cancer Institute and Research Center/US Oncology Research, Ore., and include:

Two-Year Follow-up Results from the Phase 1-2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma (Abstract #238, oral presentation at 2:45 p.m. ET on Saturday, December 7, 2019) Data were reported from 93 patients with relapsed or refractory classical HL after failure of frontline therapy who received the combination regimen of ADCETRIS plus OPDIVO. After completion of the fourth cycle of treatment, patients were eligible to undergo an autologous stem cell transplant (ASCT). The median age of patients was 34 years. These results will be highlighted in an oral presentation by Alison J. Moskowitz, M.D., Memorial Sloan Kettering Cancer Center, NY, and include:

About Classical Hodgkin Lymphoma Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,110 cases of Hodgkin lymphoma will be diagnosed in the United States during 2019 and 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions in 2013 for patients with (1) HL after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) sALCL after failure of at least one multi-agent chemotherapy regimen. Non-conditional approval was granted for (3) post-ASCT consolidation treatment of patients with HL at increased risk of relapse or progression in 2017, (4) adult patients with pcALCL or CD30-expressing MF who have received prior systemic therapy in 2018, (5) for previously untreated patients with Stage IV HL in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and (6) for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 73 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

About Seattle Genetics Seattle Genetics, Inc. is an emerging multi-product, global biotechnology company that develops and commercializes transformative therapies targeting cancer to make a meaningful difference in peoples lives. ADCETRIS (brentuximab vedotin) utilizes the companys industry-leading antibody-drug conjugate (ADC) technology and is currently approved for the treatment of multiple CD30-expressing lymphomas. Beyond ADCETRIS, the company has a late-stage pipeline including enfortumab vedotin for metastatic urothelial cancer, currently being reviewed for approval by the FDA, and tisotumab vedotin in clinical trials for metastatic cervical cancer, which utilize our proprietary ADC technology. In addition, tucatinib, a small molecule tyrosine kinase inhibitor, is in late-stage development for HER2-positive metastatic breast cancer and in clinical development for metastatic colorectal cancer. We are also leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents in clinical trials targeting hematologic malignancies and solid tumors. The company is headquartered in Bothell, Washington, and has a European office in Switzerland. For more information on our robust pipeline, visit http://www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNINGPROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Most Common (20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.

Drug Interactions Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here.

Forward Looking Statements Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential uses and benefits of ADCETRIS (brentuximab vedotin) in combination with OPDIVO (nivolumab) in frontline Hodgkin lymphoma (HL) patients age 60 years or older and in relapsed or refractory classical HL under staggered and concurrent dosing schedules, the therapeutic potential of ADCETRIS in these indications and the companys clinical development plans. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include potential lack of efficacy or risk of adverse events associated with the use of ADCETRIS in certain clinical settings and the difficulty and uncertainty of pharmaceutical product development. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption Risk Factors included in the companys Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Opdivo is a registered trademark of Bristol-Myers Squibb Company.

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Seattle Genetics Announces Updated Data of ADCETRIS (Brentuximab Vedotin) in Combination with OPDIVO (Nivolumab) in Frontline and Relapsed or...

I have a few goals in mind when I put together an outfit, and looking polished is one of my main sartorial objectives. So when I shop, I tend to gravitate toward those inherently sophisticatedseparatesto keep my wardrobe as elevated as possible. While I have a slew of go-to items in my arsenal to incorporate into my "refined, grown-up-feeling" looks (like sleek turtlenecks and tailored trousers), there's actually a range of 2020 trends that have polished-feeling qualities that I'm interested in testing out.

And believe it or not, some of the most stylish and sophisticated fashion people are actually already on board with these must-try trends because I've been spotting many in question all over my Instagram feed over the last few weeks.On that note, keep scrolling to check out the next-wave refined trends I'm lovingas seen on some of the chicest women. And because I strongly believe said looks will bring a polished spin to any of your outfits, I also shopped out each trend for all of you elegant ladiesout there.

A tailored silhouette will bring a sophisticated feel to any vibe, and the almighty vest is one of those old-school yet seemingly fresh pieces to achieve that look. Whether worn as part of a three-piece suit or worn on its own with a blouse, the waistcoat is one piece Im looking forward to spotting more and more in 2020.

Pixie Market Vest ($98)

Topshop Blush Vest ($75)

Iro Holz Belted Leather Vest ($1400)

Pointed pumps and sleek ankle boots can act as the finishing touch to an especially refined look, but non-basic loafersthose with chunky block heels and with glossy details like patentwill no doubt rise up to be the It shoe silhouette amongst the fashion crowd. While I love the idea of wearing the footwear style with cropped trousers and a jacket, Im also into these loafers because they can bring that unexpected polish to a cool denim-and-sweater vibe as well.

Michael Michael Kors Declan Kilte Fringe Pumps ($129)

Halogen Isabelle Pointy Toe Pumps ($100)

Louise Et Cie Lanton Loafer Pump ($83)

While the upgraded trench coat isnt necessarily a new trend, its one thats entering the spotlight in an even more noteworthy way next year. Designers from Sacai to Oscar de la Renta showcased a range of reimagined cuts with asymmetrical designs, unexpected pattern-blocking, and more. Fashion girls (and myself) are champions of this look for its classic yet modern sensibilities.

ASOS DESIGN Trench Coat ($119)

Leandra x Mango Detachable Gilet Trench ($300)

Court & Rowe Plaid Lined Double-Breasted Trench Coat ($299)

Its no secret that tossing on a blazer will add polish to an outfit. While the slouchy styles of the 2010s will hold their own, theres one micro-trend Im particularly feeling as an alternativethe collarless blazer. Cropping up among the cool set, this updated silhouette feels modern and a bit more relaxed than a traditional blazer paired with a tee and trousers or over a turtleneck with a midi skirt.

Bevza Olive Jacket ($626)

Pixie Market Square Neckline Jacket ($139)

H&M Textured-Weave Jacket ($55)

This bold trend is clearly incredibly popular now, but as designers from Khaite to Tory Burch proved on the S/S 20 runways, the look will be bigger (literally) than ever next year as a statement-making way to enhance a silhouette. Fashion girls seem to lean into the trend in the form of colorful cardigans or in playful midi dresses.

& Other Stories Square-Neck Jacquard Top ($89)

ASTR the Label Ruched Front Midi Dress ($85)

Tibi Cozette Sweater ($350)

Yes, a standard white button-down is timeless in theory, but Bevza, Pyer Moss, and more made a strong case for the reworked white shirt in their S/S20 collections. Here Im talking about cuts with extra-long sleeves, cropped hems, and so on. Like I just mentioned, the white shirt will always bring sophistication, but the amped-up versions will bring that forward polish that just feels so right.

Topshop Layered Ruffle Blouse ($55)

Ganni Statement Collar Poplin Shirt ($145)

New Look Peplum Shirt ($37)

Fashion people embraced leather separates this season, and the lookone typically reserved for fall and winterwill have a moment come spring 2020 as well. While the classic black moto jacket will be a forever-staple in my eyes,Im gravitating towardthose leather trenches and wrap jackets in rich hues.

Leith Faux Patent Leather Trench Coat ($149)

Club Monaco Ohwen Leather Jacket ($595)

Eloquii Trench Coat ($180)

Next, check out four cheap and chic outfits to test out this winter.

This article originally appeared on Who What Wear

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7 Refined Trends for All the Stylish Grown Women Out There - Yahoo Lifestyle

By Lisa Rapaport

(Reuters Health) Babies who are born too early may be more likely to develop diabetes as children and young adults than full-term infants, a new study suggests.

In a study of children up to age 18, those born before 37 weeks gestation were 21% more likely that those born at full term to develop type 1 diabetes, the less common form of the disease that typically appears in childhood or young adulthood. Kids born prematurely were also 26% more likely to develop type 2 diabetes in childhood.

And preemies were 24% more likely to develop type 1 diabetes and 49% more likely to develop type 2 diabetes by the time they were 43 years old.

Preterm birth interrupts normal development of multiple organ systems, including the pancreas where insulin-producing cells are formed, which may potentially contribute to later development of diabetes, said lead study author Dr. Casey Crump of the Icahn School of Medicine at Mount Sinai in New York City.

Pregnancy normally lasts about 40 weeks, and babies born after 37 weeks of gestation are considered full-term. Babies born prematurely earlier than 37 weeks often have difficulty breathing and digesting food in the weeks after birth. Preemies can also encounter longer-term challenges such as impaired vision, hearing and cognitive skills, as well as social and behavioral problems.

Some previous research suggests that preemies have an increased risk of developing so-called insulin resistance, a failure to respond normally to the hormone insulin.

In type 1 diabetes, the pancreas cant produce insulin. In the type 2 form of the disease, which is often linked to obesity and aging, the body cant properly use or make enough insulin to convert blood sugar into energy.

For the current study, researchers examined data on almost 4.2 million babies born in Sweden from 1973 to 2014. Most were followed until they were at least 22 years old.

Overall, 0.7% of the babies in the study population went on to develop type 1 diabetes and just 0.1% developed type 2 diabetes, the researchers report in Diabetologia.

Parents should know that most children who were born preterm will have good health in childhood and adulthood, Crump said by email. However, they also have modestly increased risks of diabetes that persist into adulthood.

Overall, the risk tended to be higher for preemie girls. Boys who arrived early were about 20% more likely to develop type 1 diabetes during the study, while girls had about a 30% greater likelihood.

With type 2 diabetes, female preemies were 60% more likely to develop this disease during childhood than full-term babies, while preemie males didnt have an increased risk. For young adults in the study, women who were preemies had a 75% increased risk of type 2 diabetes and men who were preterm had a 28% increased risk.

Many people in the study had siblings included in the analysis. Shared genetics and family circumstances appeared to explain some, but not all, of the increased risk of diabetes for preemies.

The study wasnt designed to prove whether preterm birth influences susceptibility to diabetes.

Even so, the results underscore that preemies need to take steps to prevent diabetes later in life, said Ciaran Phibbs of the VA Palo Alto Health Care System and Stanford University School of Medicine in California.

The home environment is an important factor, especially for type 2 diabetes, Phibbs, who wasnt involved in the study, said by email. This includes things like diet and exercise habits, which can impact the risk of obesity, which is higher for preemies than for full-term babies and is a risk factor for diabetes, he said.

Individuals who were born preterm can help prevent diabetes by following a healthy lifestyle across the life course, including a healthy diet, regular physical activity, and maintaining a normal weight, Crump advised.

SOURCE: https://bit.ly/2LCQrpq Diabetologia, online December 3, 2019.

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Preemies face higher risk of diabetes as children and young adults - Physician's Weekly

GLEN MILLS, Pa., Dec. 10, 2019 /PRNewswire/ --SmartSolutions RX, Inc. announces the launch of a new scientifically based, drug-free hair support system LOCKrx, which includes both ingestible and topical Healthy Hair Programs that create the ideal environment to maintain hair follicle cycle and growth.

Hair thinning and hair loss are a pervasive problem, affecting an estimated 80 million men and women in the U.S. Smoking, diet, stress, environment and genetics all contribute to hair loss, as well as the hormone DHT which shrinks the hair follicle and is the primary cause of loss in male and female pattern baldness. The current treatments often come with unwanted side effects and take months to generate results.

LOCKrx is a drug-free hair treatment system that addresses scalp health, both internally and externally, that directly impacts hair growth and quality.

"When formulating LOCKrx, we meticulously designed and tested both ingestible and topical ingredients that are scientifically proven to reduce the inflammation associated with damaged hair follicles and thereby improve quality of the hair," said Cynthia Rager, President and COO of Vision Medical, Inc. "Our topical LOCKrx solutions include specific growth factors clinically shown to play a key role in the hair follicle growth pathway as well as to enhance wound repair and skin regeneration, all of which improve scalp skin health, while also playing a vital role in the proliferation of skin and hair cells."

LOCKrx is available as both internal and external treatment plans, designed to work synergistically to promote healthy scalp skin and hair growth.

"Growthfactors possess the ability to stimulate hair growth through variousmechanistic pathways," said Richard Jin, M.D., Ph.D., Hair Regeneration Specialist, RJClinical Institute. "We have experienced very positive results when combiningthese with platelet rich plasma therapy to promote new and existing hairgrowthas well as using it as an alternative to PRP. This has helped us treat the mostcommon form of hair loss known as androgenetic alopecia, as well as increasethickness and density of hair in post-transplant patients."

LOCKrx Inside Healthy Hair Programis a 3-step, 6-week ingestible plan that uses unique marine and botanical ingredients, amino acids, and vitamins to address total body inflammation.

1. DEFENSE Gut Health - Prebiotic supplement that includes mineral-rich blue green algae and proven anti-inflammatory botanicals curcumin, aloe, licorice and beta-glucan to address gut health in powdered form.

2. BLOCK Hair Loss- Follicle-enrichment supplement formulated with the LOCKrx proprietary blend of botanicals, adaptogens, marine collagen, and saw palmetto to help support hair growth and block conversion of testosterone to DHT, one of the major causes of hair loss in male and female pattern baldness.

3. GUARD Healthy Hair Tabs- Premier blend of complexed Vitamin B plus biotin in the most bio-available form.

LOCKrx Outside Healthy Hair Programis a combination of clinical and at-home applications of growth factor solutions that support and balance the scalp microbiome, while enhancing the environment for healthy hair growth:

VisionMedical, Inc. has exclusive physician distribution rights for LOCKrx.

Smart Solutions RX, Inc.

Smart Solutions RX, Inc. formulates, develops, manufactures and distributes products for medical aesthetic applications to hair and skin. A blend of scientific research and innovative formulation and delivery systems are the hallmark, as evidenced in the LOCKrx brand for healthy hair support. Medical aesthetic protocols and workshops are integrated into the superior customer support program. http://www.smartsolutionsrx.com

Vision Medical, Inc.

Founded in 2013, VisionMedical, Inc. develops, manufactures, and marketsmedical and aesthetic technology for the medical and aesthetic marketsfor worldwide distribution.Vision Medical's first commercial product, theSmartGraft Hair Restoration System, incorporates an award-winning Automated Follicular Unit Extraction (FUE) system for men and women.Featuring theindustry's first closed harvesting system, SmartGraft allows physicians to harvestgrafts more efficiently while keeping grafts moist prior to implantation. http://www.SmartGraft.com.

CONNECT WITH US

Instagram: @SmartSolutionsRXTwitter: @SSolutionsX Facebook: @SmartSolutionsRXinc

SOURCE SmartSolutions RX, Inc.

http://www.smartsolutionsrx.com

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SmartSolutions RX Launches LOCKrx, A Drug-Free Support System Fighting To Keep Hair Thick and Healthy - PRNewswire

Separation of church and state has long shaped the relationships of public institutions.

And despite its recent collaborations, the University of California is not exempt.

Currently, the UC is contracted with Dignity Health, a Catholic health care nonprofit corporation, to provide university care for more patients and medical student training. Unsurprisingly, this has sparked concerns statewide from physicians and students over how religiously affiliated hospitals undermine health care for LGBTQ+ groups and women.

Dignity Health operates under the Ethical and Religious Directives for Catholic Health Care Services, which uses religious ideology as a basis to determine the conduct of on-site operations. These directives directly limit physicians ability to conduct procedures permitted outside of these limitations, such as lifesaving womens health services. And because of this partnership, those restrictions apply to on-site UC physicians.

Earlier this year, protests amongst physicians, students and activist groups broke out at UCSF and UCLA in response to the contracts potentially expanding UC-wide. The protests found success in San Francisco, and UCSF ended affiliation discussions with Dignity Health in May. At UCLA, the contracts still stand.

If state health care institutions are secular, treatment is mandated to be equal no matter patients beliefs, gender or orientation.

But currently, the UC subjects itself to the hospitals religious doctrine and enables religious influences in health care, even if it means restricting access for women and LGBTQ+ people. Whether or not these doctrines impact the performance of UC physicians one time or every time, an overarching religious presence potentially influencing medical decisions is unacceptable.

Because when religiosity facilitates discrimination in health care, it must be contested by the UC system.

Earlier this year, it was reported that 24 out of 39 Dignity hospitals reject the use of gender-affirming practices such as hormone therapy and surgeries. But access to LGBTQ+-supportive health care goes beyond what occurs under the knife.

Nina Sheridan, a fourth-year molecular, cell and developmental biology student and UCLA Sexperts co-director, said refusing such procedures can invalidate the identity of transgender individuals.

Not offering any sort of gender-affirming type of health care leads to the erasure of these communities, because youre negating the importance of treating their bodies the way that they want their bodies to be treated, Sheridan said.

And with every UC contract that doesnt address these barriers, the UC is complacent in this erasure.

Evan Minton, a transgender patient, was denied his scheduled hysterectomy the day before the procedure. In a California appellate court case, Minton claimed he was denied care because of his gender identity, while Dignity Health claimed the procedure violated its ethical and religious directives, which include sterilization.

Although the directives do not explicitly discriminate against services that affirm gender identity, flexible interpretations of these standards allow Catholic hospitals to justify their refusal of treatment.

And the LGBTQ+ community isnt the only one hurt by Dignitys religious doctrines. Education and resources for womens sexual health range from limited to nonexistent for example, institutions are prohibited from condoning or promoting contraceptives.

If theyre not being completely transparent about birth control options and are not talking about it in the best interest of the patient, that completely eradicates an educational aspect of health care that should be available to every single woman, Sheridan said.

This includes education about how birth control can be used to regulate menstrual symptoms, treat polycystic ovary syndrome and prevent ovarian or uterine cancer. Outright denial of birth control isnt just affecting womens sexual health it restricts their access to health care education and their ability to treat outstanding medical conditions.

And while abortion might be a more divisive topic, these restrictions have unintended consequences especially when abortive measures serve to ensure the safety of a womans life.

This means a miscarrying patient with a fetal heartbeat can be denied a lifesaving procedure, such as uterine evacuation, by a closed-door ethics committee. Their physician can make a few choices: wait for the heartbeat to stop and risk bleeding out or septic infection, transport the patient to the closest hospital despite having the necessary lifesaving equipment or violate protocol altogether. And according to a UCSF study, these are choices many physicians had to make under the constraints of the ethical and religious directives.

Its a choice that can mean life or death for the patient.

Our relationships with other entities that facilitate health services and clinical training at non-UC facilities support our mission of meeting patients unmet needs and training the health care workforce California needs, said a spokesperson for the UC.

The necessary symbiotic relationship between public institutions and nonprofits is obvious, and while the UC insists its physicians will make the right medical calls despite the directives, there are dangerous implications of having religious limitations in the medical field.

Some of the language in the agreements may not sufficiently reflect our values and expectations, and we are working to address legitimate concerns that have been raised, said a spokesperson for UCLA Health and the David Geffen School of Medicine at UCLA.

Every hospital, no matter its religious beliefs, should have access to experts and professionals like those from the UCs. A statement from Dignity Health said dissolving these partnerships would be detrimental to certain communities and theyre not wrong. Dignity Health has every right to conduct its operations within the framework of its religious doctrine something that draws certain people to these hospitals.

But it shouldnt come at the cost of restricting potentially lifesaving operations or making patients afraid of disclosing their sexual orientation or gender identity.

The UC claims to support womens health and the LGBTQ+ community but has yet to negotiate a contract that can ensure health care without the inhibiting influence of religious doctrine.

Increasing contracts is integral to providing health care for all.

But when it comes at the cost of equal access for women and LGBTQ+ members, its time to go back to the drawing board.

Originally posted here:
UC's affiliation with Dignity Health unfairly places restrictions on health care - Daily Bruin

To reverse a medical abortion, some doctors have prescribed progesterone. A new study raises fresh doubts about the approach. Photo Researchers, Inc./Science Source hide caption

To reverse a medical abortion, some doctors have prescribed progesterone. A new study raises fresh doubts about the approach.

A study designed to test the effectiveness of a controversial practice known as "abortion pill reversal" has been stopped early because of safety concerns.

Researchers from the University of California, Davis, were investigating claims that the hormone progesterone can stop a medication-based abortion after a patient has completed the first part of the two-step process.

For the study, the researchers aimed to enroll 40 women who were scheduled to have surgical abortions. Before their surgical procedures, the women received mifepristone, the first pill in the two-medication regimen that's used for medical abortions. The women were then randomly assigned to receive either a placebo or progesterone, which advocates claim can block the effects of mifepristone.

But researchers stopped the study in July, after only 12 women had enrolled. Three of the women required ambulance transport to a hospital for treatment of severe vaginal bleeding.

The researchers decided the risk to women of participation was too great to continue with the study. The study was unable to show what, if any, effectiveness progesterone has in reversing a medical abortion.

The results raise concerns about the safety of using mifepristone without taking misoprostol, the second step in the medication-based abortion regimen.

Advocates for abortion pill reversal have succeeded in having it written into law as an option to be discussed in mandatory pre-abortion counseling in several states, including Kentucky, Nebraska and Oklahoma.

Opponents have said there wasn't sufficient evidence to support the approach. Now, there's evidence that it could cause harm.

"Encouraging women to not complete the regimen should be considered experimental," says Dr. Mitchell Creinin, a professor of obstetrics and gynecology at UC Davis and the lead researcher on the study. "We have some evidence that it could cause very significant bleeding."

The results of the trial were published online Thursday in the journal Obstetrics and Gynecology.

Medication-based abortions use a combination of two medicines mifepristone and misoprostol that patients usually take 24 hours apart. Mifepristone is a progesterone blocker. Misoprostol makes the uterus contract. Studies suggest that 95% to 98% of women who take both drugs in the prescribed regimen will end their pregnancy safely.

Proponents of the abortion-reversal treatment offer the hormone progesterone to patients after they have taken mifepristone but have then decided they don't want to complete the abortion. A group of researchers published a small case series about the protocol, claiming it prevents the abortion from taking place.

The research has been criticized for having serious methodological flaws. Most OB-GYNs including the professional group the American College of Obstetricians and Gynecologists oppose the practice, saying it's "not supported by science."

At least seven states, however, legally require abortion providers to tell patients about progesterone treatment for stopping a medication-based abortion midway through.

This advice, Creinin says, may put patients at risk for life-threatening bleeding.

"It's not that medical abortion is dangerous," he says. "It's not completing the regimen, and encouraging women, leading them to believe that not finishing the regimen is safe. That's really dangerous."

Although Creinin acknowledges that his study was limited by its premature termination and small sample size, he hypothesizes that taking mifepristone without misoprostol may be especially risky later in the first trimester of pregnancy. All three patients with severe bleeding were at least 56 days into their pregnancies.

The women who experienced hemorrhage included one who received progesterone and two who received a placebo. Of the remaining participants, two left the study because of side effects and completed their planned surgical abortions.

Women in both the progesterone and placebo groups had some evidence that their pregnancies continued. Four patients who took mifepristone and then received progesterone had pregnancies with cardiac activity on ultrasound. Two patients who got the placebo also had gestational cardiac activity.

Creinin says that because the study was cut short, it wasn't big enough to answer the question it set out to. There simply aren't enough data, he says, to know if the progesterone treatment is effective at preventing a medication-based abortion from taking place.

"Does progesterone work? We don't know," he says. "We have no evidence that it works."

Mara Gordon is a family physician in Camden, N.J., and a contributor to NPR. You can follow her on Twitter: @MaraGordonMD.

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Study Of Progesterone To Reverse Medication Abortion : Shots - Health News - NPR