Archive for December, 2019

In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering -- by editing her genome.

Victoria Gray's recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research -- gene therapy.

"I have hoped for a cure since I was about 11," the 34-year-old told AFP in an email. "Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency."

Over several weeks, Gray's blood was drawn so doctors could get to the cause of her illness -- stem cells from her bone marrow that were making deformed red blood cells.

The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 -- pronounced "Crisper" -- a new tool informally known as molecular "scissors."

The genetically edited cells were transfused back into Gray's veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary but, theoretically, she has been cured.

"This is one patient. This is early results. We need to see how it works out in other patients," said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville. "But these results are really exciting."

In Germany, a 19-year-old woman was treated with a similar method for a different blood disease, beta thalassemia. She had previously needed 16 blood transfusions per year.

Nine months later, she is completely free of that burden.

For decades, the DNA of living organisms such as corn and salmon has been modified.

But Crispr, invented in 2012, made gene editing more widely accessible. It is much simpler than preceding technology, cheaper and easy to use in small labs.

The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself.

"It's all developing very quickly," said French geneticist Emmanuelle Charpentier, one of Crispr's inventors and the cofounder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Crispr is the latest breakthrough in a year of great strides in gene therapy, a medical adventure started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy.

Scientists practising the technique insert a normal gene into cells containing a defective gene.

It does the work the original could not -- such as making normal red blood cells, in Victoria's case, or making tumor-killing super white blood cells for a cancer patient.

Crispr goes even further: instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the U.S. and a blood disease in the European Union.

They join several other gene therapies -- bringing the total to eight -- approved in recent years to treat certain cancers and an inherited blindness.

Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution.

"Twenty-five, 30 years, that's the time it had to take," he told AFP from Paris. "It took a generation for gene therapy to become a reality. Now, it's only going to go faster."

Just outside Washington, at the National Institutes of Health (NIH), researchers are also celebrating a "breakthrough period."

"We have hit an inflection point," said Carrie Wolinetz, NIH's associate director for science policy.

These therapies are exorbitantly expensive, however, costing up to $2 million -- meaning patients face grueling negotiations with their insurance companies.

They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion -- and fighting a general infection. "You cannot do this in a community hospital close to home," said her doctor.

However, the number of approved gene therapies will increase to about 40 by 2022, according to MIT researchers. They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who don't necessarily share the medical ethics of Western medicine.

Last year in China, scientist He Jiankui triggered an international scandal -- and his excommunication from the scientific community -- when he used Crispr to create what he called the first gene-edited humans.

The biophysicist said he had altered the DNA of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV, even though there was no specific reason to put them through the process.

"That technology is not safe," said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr "scissors" often cut next to the targeted gene, causing unexpected mutations.

"It's very easy to do if you don't care about the consequences," Musunuru added.

Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability.

There is also the temptation to genetically edit entire animal species -- malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the U.S.

The researchers in charge of those projects are advancing carefully, however, fully aware of the unpredictability of chain reactions on the ecosystem.

Charpentier doesn't believe in the more dystopian scenarios predicted for gene therapy, including American "biohackers" injecting themselves with Crispr technology bought online.

"Not everyone is a biologist or scientist," she said.

And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies' crops?

Charpentier thinks that technology generally tends to be used for the better.

"I'm a bacteriologist -- we've been talking about bioterrorism for years," she said. "Nothing has ever happened."

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2019: the year gene therapy came of age - Japan Today

DURHAM, N.C., Dec. 10, 2019 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq: CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that data relating to its dociparstat sodium (DSTAT) program, formerly known as CX-01, were presented at the 61st American Society of Hematology Annual Meeting, in Orlando, FL.

The poster, titledUpdated Study Results for CX-01, an Inhibitor of CXCL12/CXCR4, With Azacitidine for the Treatment of Hypomethylating Agent Refractory AML and MDS, was presented byEric Huselton, M.D., Assistant Professor of Medicine at the University of Rochester on December 9, 2019.

As reported in the published study abstract, 20 patients with refractory myelodysplastic syndrome (MDS) (n = 9) or refractory acute myeloid leukemia (AML) (n = 11) were enrolled of which 15 were considered evaluable for response with a bone marrow biopsy after cycle 2. Patients received a 7-day continuous infusion of DSTAT (CX-01) at a dose of 0.25 mg/kg/hour, and azacitidine 75 mg/m2 daily days 1-7, in 28-day cycles. The primary objective of this trial was to assess the overall response rate. Half of the patients had high risk cytogenetic abnormalities and 3 had TP53 mutations. Patients had a median of 2 prior lines of therapy (range 1-3) with median of 6 prior cycles of hypomethylating agent (HMA) therapy (range 4-20). Only 4 patients had a confirmed response to prior HMA therapy.

The 15 evaluable patients received a median of 3 cycles of CX-01 and azacitidine (range 2-9). Of 15 evaluable patients, there was 1 CR (complete remission) and 3 bone marrow CRs (mCR, with incomplete peripheral blood count recovery), 9 stable disease, and 2 progressive disease for an overall response rate of 27%. Of the 3 patients with a mCR after cycle 2, two had hematologic improvement of their neutrophil and platelet counts, respectively, by the end of cycle 4. A patient with stable disease also had hematologic improvement in platelets.

The median overall survival of evaluable patients was 221 days. The median overall survival was not significantly different between AML patients at 221 days and MDS patients at 248 days.

Following a minimum of 4 cycles of prior HMA therapy, one would not expect to observe response to subsequent HMA therapy, said Dr. Huselton. These results demonstrate DSTATs potential to improve HMA therapy outcomes in terms of both response and overall survival.

"DSTATs mechanism of action is intended to enhance patient benefit when combined with an active agent, so to observe these results in HMA-refractory patients is promising. In addition to our planned Phase 3 pivotal trial in newly diagnosed AML, this study highlights the potential to develop DSTAT to enhance the benefit of multiple therapies such as azacitidine, in AML and MDS in both front-line and recurrent settings," said Mike Sherman, Chief Executive Officer of Chimerix.

AboutChimerix

Chimerixis a development-stage biopharmaceutical company dedicated to accelerating the advancement of innovative medicines that make a meaningful impact in the lives of patients living with cancer and other serious diseases. The two clinical-stage development programs are dociparstat sodium (DSTAT) and brincidofovir (BCV).

Dociparstat sodium is a potential first-in-class glycosaminoglycan biologic derived from porcine heparin that has low anticoagulant activity but retains the ability to inhibit activities of several key proteins implicated in the retention and viability of AML blasts and leukemic stem cells in the bone marrow during chemotherapy (e.g., CXCL12, selectins, HMGB1). Mobilization of AML blasts and leukemic stem cells from the bone marrow has been associated with enhanced chemosensitivity and may be a primary mechanism accounting for the observed increases in EFS and OS in Phase 2 with DSTAT versus placebo. Randomized Phase 2 data suggest that DSTAT may also accelerate platelet recovery post-chemotherapy via inhibition of platelet factor 4, a negative regulator of platelet production that impairs platelet recovery following chemotherapy. BCV is a lipid conjugate DNA polymerase inhibitor in development as a medical countermeasure for smallpox.For further information, please visit the Chimerix website,www.chimerix.com

CONTACT:

Investor Relations:Michelle LaSpaluto919-972-7115ir@chimerix.com

Will OConnorStern Investor Relations212-362-1200will@sternir.com

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Chimerix Presents Updated Results from Phase 2 Clinical Trial of DSTAT in Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia at American...

Using immunotherapy with genetically modified T cells that express chimeric antigen receptors or CARs designed to target tumor-associated molecules, have impressive efficacy in the treatment hematological malignancies.

A CAR is a synthetic construct that, when expressed in T cells, mimics T cell receptor activation and redirects specificity and effector function toward a specified antigen.[1]

In the treatment of cancer, this process is accomplished by linking an extracellular ligand-binding domain specific for a tumor cell surface antigen to an intracellular signaling module that activates T cells upon antigen binding.[1]

The presented studies include results from emerging second-generation cellular immunotherapy products that strive to overcome the limitations of existing products such as resistance and reduce toxicity and simplify treatment.

Cellular immunotherapy uses genetic engineering to enhance the ability of the immune system the bodys defense system against infection and disease to kill malignant cells in the blood, the bone marrow, and other sites, in order to keep cancer from coming back.

CAR T-cell TherapyChimeric antigen receptor T-cell therapies, better known as CAR T-cell therapies, are developed by harvesting a patients own T-cells, the immune systems primary cancer-killing cells, engineering them to target proteins specific to the surface of cancer cells, and reintroducing these modified T-cells back into the patients immune system to kill the cancer cells.

First generationFirst-generation CAR T-cell therapies primarily target CD-19, a protein found on the surface of most normal and malignant B cells in B cell cancers such as lymphoma. These therapies have been shown to produce long-term remissions in about one-third of patients with B-cell lymphomas that have not responded to prior therapies.

We are now seeing efforts to enhance the effectiveness of CAR T-cell therapy by designing products capable of attacking multiple targets, expand the availability of cellular immunotherapy to other blood cancers such as multiple myeloma and replace the complex manufacturing process required for CAR T-cell therapy with a uniform off-the-shelf product, noted Gary Schiller, MD, UCLA Health, an academic medical center which includes a number of hospitals and an extensive primary care network in the Los Angeles, California, region.

One of the phase I studies evaluates an off-the-shelf cellular immunotherapy product that targets two proteins found on the surface of lymphoma cells, including its potential to revive previously administered CAR T-cells that have stopped working.

Another study presents preclinical results for one of the first cellular immunotherapies to be based on off-the-shelf natural killer (NK) cells and the first, according to its manufacturer, to be genetically engineered to contain three active anti-tumor components.

The other two studies, also phase I studies, assess novel CAR T-cell therapies for multiple myeloma that test different dual-target strategies.

One investigational agent is genetically engineered to contain two proteins that attach to BCMA, a protein found almost exclusively on the surface of plasma cells, the immune-system cells that become cancerous in multiple myeloma.

The other is designed to target both BCMA and CD-38, another protein found on the surface of plasma cells. In both studies, many patients achieved minimal residual disease (MRD) negativity, which means that using highly sensitive testing fewer than one myeloma cell per 100,000 cells was identified in the bone marrow. Previous studies have shown that patients who achieve this milestone have a lower risk of relapse after more than three years of follow-up.

Dual-targeted CAR T-cell therapiesThe three phase I studies also hint at the possibility that dual-targeted CAR T-cell therapies might result in fewer patients experiencing moderate to severe cytokine release syndrome (CRS), a known adverse effect caused by an immune response in the body to the activated T cells that are attacking the cancer. CRS causes flu-like symptoms such as fever, body aches, and fatigue, and in severe cases can be life-threatening. Treatment with the drug tocilizumab can reduce CRS symptoms.

Dual-Targeted Antibody Elicits Durable ResponsesPatients with B-cell Non-Hodgkin Lymphoma (NHL) that had returned after or failed to respond to a median of three prior therapies showed complete responses (CR) and durable remissions after being treated with an investigational drug called mosunetuzumab (RG7828; Genentech/Roche). [2]

This investigational agent is a humanized, T-cell bispecific antibody designed to engage T cells and redirect their cytotoxic activity against malignant B cells. The drug works by activating the patients own T-cells, stimulating them to attack and kill cancerous B cells to which they have been introduced by the novel antibody.

Mosunetuzumab simultaneously binds to CD3 epsilon (CD3), a component of the T-cell receptor (TCR) complex, and to CD20, a B-cell surface protein expressed in a majority of B-cell malignancies. This results in crosslinking of the TCR, inducing downstream signaling events that leads to B-cell killing.

Among patients whose lymphoma progressed after treatment with CAR T-cell therapy, 22% had complete remissions when treated with mosunetuzumab. This new drug targets two proteins, one on the surface of tumor cells and the other on the surface of the recipients Tcells.

Unlike CAR T-cell therapy, mosunetuzumab is an off-the-shelf immunotherapy product that can be given to patients without having to genetically modify their T cells, noted lead author Stephen J. Schuster, MD, of Abramson Cancer Center at the University of Pennsylvania in Philadelphia.

Mosunetuzumab generates long-lasting responses with a very tolerable safety profile in patients with B-cell non-Hodgkin lymphomas for whom multiple prior treatments have failed and whose prognosis is poor. Of particular interest, we are seeing durable complete remissions in patients whose lymphomas progressed after CAR T-cell therapy, he added.

The researchers observed many remissions continue after patients stop receiving the drug.

I have stopped therapy in some patients after six months and they have remained in remission. Some patients have remained in remission without additional therapy for more than a year, Schuster said.

New treatment options are needed not only for patients in whom CAR T-cell therapy has failed, but also for those patients whose lymphomas are getting worse so quickly that they cannot wait for CAR T-cell manufacturing, which takes several weeks, Schuster explained.

The data presented during the annual meeting of the American Society of Hematology included 270 patients (median age 62, 172 men) enrolled in the phase I trial in seven countries (the United States, Australia, Canada, Germany, South Korea, Spain, and the United Kingdom). All participating patients had B-cell lymphomas that had come back or not responded to a median of three prior therapies. Two-thirds of patients (67%) had fast-growing lymphomas; 85 (31%) patients had more slow-growing forms of the disease. In 30 patients (11%), the cancer was resistant to or returned after an initial response to CAR T-cell therapy; in 77 patients (29%), the disease had progressed after a stem cell transplant.

All patients were treated with mosunetuzumab by intravenous infusion. They had an imaging test at either six weeks or three months after starting therapy to assess the initial response to treatment, and responses continued to be followed every three months thereafter.

Forty-six of 124 patients with fast-growing lymphomas (37%) had measurable decreases in the extent of their cancer (objective response); 24 of 124 patients (19%) saw all detectable tumors disappear (complete response). A higher response rate was observed in patients with higher exposure to mosunetuzumab. Among patients with slow-growing lymphomas, 42 of 67 (63%) had objective responses and 29 of 67 (43%) had complete responses. Both objective response rate and complete response rate were maintained in subgroups of patients at high risk for relapse.

Complete remissions appear to be long lasting, Schuster said.

With a median follow-up of six months since first complete remission, 24 of 29 patients (83%) who achieved complete remissions of their slow-growing lymphomas and 17 of 24 patients (71%) who achieved complete remissions of their fast-growing lymphomas remain free of disease. In some patients whose cancers progressed after receiving CAR T-cell therapy, highly sensitive molecular testing showed that the previously administered CAR T cells increased in number.

This suggests that, in addition to its ability to kill cancerous B cells, mosunetuzumab may also help augment the effect of the prior CAR-T treatment, Schuster noted.

Cytokine-release syndromeIn this study, 29% of patients treated with mosunetuzumab experienced cytokine-release syndrome that was mostly mild.

Cytokine release syndrome or CRS is caused by a large, rapid release of cytokines into the blood from immune cells affected by the immunotherapy. While most patients have a mild reaction, sometimes patients may have a severe, life threatening, reaction.

In 3% of patients, CRS was treated with tocilizumab (Actemra; Genentech/Roche). Four percent of patients experienced moderately severe neurologic side effects. Patients who received higher doses of mosunetuzumab were no more likely to have CRS or neurologic side effects than patients treated at lower doses.

A study of a higher dose of mosunetuzumab is now enrolling patients and long-term follow-up of these patients will ultimately help to better evaluate the durability of response data.

Larger, randomized trials are needed to further confirm these promising data and determine whether the treatment benefit of mosunetuzumab is enhanced when it is used earlier in the course of lymphoma therapy or in combination with other agents, Schuster concluded.

Novel Off-the-Shelf CARPreclinical studies provide the first evidence that cellular immunotherapy for B cell cancers could ultimately become an off-the-shelf product, capable of being uniformly manufactured in large quantities as prescription drugs are.

We have taken the concept of traditional pharmaceutical drug development and applied it to cellular therapy, explained senior author Bob Valamehr, Ph.D, of Fate Therapeutics, a San Diego biopharmaceutical company.

The product called FT596, is among the first cellular immunotherapies to be based on off-the-shelf NK cells the first line of defense of the immune system and is the first cellular immunotherapy to be genetically engineered to contain three active anti-tumor components, Valamehr explained.

Comparable with standard CAR T-cell therapyFT596 demonstrated comparable ability to kill cancerous white blood cells as standard CAR T-cells and, when combined with the drug rituximab (Rituxan; Genentech/Roche), killed cancerous white blood cells that were no longer responding to standard CAR T-cell therapy due to loss of the CD19 antigen target.

The U.S. Food and Drug Administration (FDA) approved Fate Therapeutics Investigational New Drug Application for FT596 in September 2019 and the company hopes to begin a first-in-human phase I clinical trial for the treatment of B-cell lymphoma and chronic lymphocytic leukemia in the first quarter of 2020.

The primary purpose of this trial will be to assess the safety and activity of FT596 in patients.

ManufacturingThe development and manufacturing of FT596 begins with human induced pluripotent stem cells (iPSCs) that are uniquely capable of unlimited self-renewal and can differentiate into more than 200 types of human cells. These iPSCs are genetically engineered, after which a single genetically engineered cell or clone is selected and multiplied in the laboratory to create a master engineered cell line that can be repeatedly used to generate cancer-fighting immune-system cells such as NK and T cells.

Natural Kiler Cells or NK cells are a type of lymphocyte and a component of innate immune system, the bodys first line of defense against infection and disease. Unlike T-cells, which have to be trained to recognize their target and can kill only cells that display that target on their surface, NK cells do not need special preparation before going on the attack and can kill many different types of transformed or infected cells.

NK cells are multifaceted and can be viewed as a jack-of-all-trades when it comes to protecting the host, whereas T cells can act in only one way, Valamehr explained.

But NK cells are also different in other ways. They are inherently limited in their capacity to multiply and expand when infused into patients, and they have a shorter lifespan.

Valamehr and his colleagues used genetic engineering to address these shortcomings. In addition to engineering FT596 to carry a CAR targeting the CD19 protein, which is produced by nearly all B-cell lymphomas and leukemias, they inserted two other novel proteins: CD16, which boosts and broadens the NK cells ability to kill cancer cells, and IL15, which stimulates FT596 to proliferate and persist.

Valamehr explained that FT596 has been designed to address two more limitations of CAR T-cell therapy .

The investigational agent is an off-the-shelf product. As a result, it significantly improves the current patient-by-patient CAR T-cell treatment paradigm by eliminating the time-consuming and costly process that is currently required to treat a patient with CAR T-cells.

The addition of the CD16 protein gives FT596 broader therapeutic activity and versatility. In combination with rituximab, FT596 has the potential to lead to deeper and more durable responses and overcome resistance that hampers the long-term efficacy of CAR T-cell therapy.

Eliminating the high production cost, weeks of manufacturing time, and complex manufacturing process required for CAR T-cell therapy and replacing it with a mass-produced, off-the-shelf product, promises to expand access to effective cell-based cancer immunotherapy to many more patients who may benefit from it, Valamehr concluded.

Results from CARTITUDE-1 in R/R Multiple MyelomaPatients with multiple myeloma who had received a median of five prior therapies, and for whom standard-of-care treatments were no longer working, had a high response rate when treated with the investigational CAR T-cell therapy JNJ-68284528 (JNJ-4528), which targets BCMA, a protein commonly found on the surface of multiple myeloma cancer cells.

These patients participated in a clinical trials (NCT03548207), supported by Janssen Research & Development, designed to characterize safety of and establish the recommended Phase II dose (RP2D) (Phase Ib) and to evaluate the efficacy of JNJ-68284528 (Phase II).

We are seeing a high response rate, with most patients achieving MRD negativity, noted lead study author Deepu Madduri, MD, of The Tisch Cancer Institute at Mount Sinai in New York.

Considering these patients have all received multiple prior therapies, these results are extremely encouraging, Madduri added.

All evaluable patients receiving this CAR T-cell therapy have achieved MRD-negative disease state and 27 of 29 patients are progression free at a median follow-up of six months, Madduri said.

Multiple myeloma is a cancer of plasma cells, which are found in the bone marrow and are part of the immune system, the bodys defense system against infection. Typical signs and symptoms of multiple myeloma may be bone pain or fractures, high levels of calcium in the blood, kidney damage, and anemia. Multiple myeloma affects an estimated 160,000 people each year, occurs most often in people over 60. The disease is slightly more common in men than in women.

Although new therapies for multiple myeloma have recently become available that can extend patients life expectancy, a cure for the disease remains elusive.

We can get the disease into remission, but most patients unfortunately relapse, and outcomes are very poor for patients who have relapsed multiple times, she said.

Researchers explained that JNJ-4528 is a novel CAR T-cell therapy featuring two molecules that bind to BCMA, a protein found on the surface of multiple myeloma cells.

We are learning that every CAR T-cell therapy is different, Madduri said.

JNJ-4528 has a unique CAR T-cell composition in patients, preferentially enriched in CD8 T cells, which are believed to be one of the most important T cells in killing cancer cells, she noted.

This phase Ib/II trial is continuing to enroll patients.

During the 2019 annual meeting of the American Society of Hematology, Madduri reported results for the first 29 patients enrolled.

Patients T-cells were collected and sent to a laboratory where they were genetically engineered to express JNJ-4528. Prior to re-infusing these CAR T-cells, the patients received three days of chemotherapy to make room in their immune systems for the engineered T-cells.

Following chemotherapy, each patient received a single infusion of the JNJ-4528 CAR T-cells.

After a minimum of 28 days, these patients had blood and bone marrow exams, which was followed by exams at six months, and one year after treatment to assess their response. The primary aims of the trial are to assess the therapys safety and to confirm the dose to be tested in a larger, phase II trial.

The median follow-up time in the current analysis is six months. Overall, 100% of patients had a clinical response to JNJ-4528. Moreover, 66% had a stringent complete response, meaning that sensitive laboratory and microscopic tests found no evidence for myeloma proteins or cells in blood, urine, or bone marrow.

Most patients (93%) experienced some form of CRS. One patient had severe (grade 3) CRS, and one patient died from its complications 99 days after the CAR T-cell infusion. In 76% of patients, CRS was treated with tocilizumab.

To see some patients in this heavily pretreated population surviving for a year or more with a one-time treatment and a manageable safety profile is remarkable, Madduri explained.

These patients feel that they have their quality of life back. They no longer have to come into the clinic for weekly treatments and some are well enough to travel, Madduri concluded.

The phase II portion of this study is ongoing to evaluate the overall response rate of patients treated with JNJ-68284528 (JNJ-4528). Additional clinical studies are evaluating the safety and efficacy of JNJ-4528 in different multiple myeloma treatment settings.

BreakthroughEarlier this week the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for JNJ-68284528 (JNJ-4528).

The granting of Breakthrough Therapy Designation for JNJ-68284528 (JNJ-4528) is a significant milestone as we continue to accelerate the global development of this innovative CAR-T therapy in collaboration with Legend Biotech, noted Sen Zhuang, MD, Ph.D., Vice President, Oncology Clinical Development, Janssen Research & Development.

We look forward to continuing to work closely with the U.S. Food and Drug Administration to advance the clinical development program for JNJ-68284528 (JNJ-4528) and ultimately bring this BCMA-targeted immunotherapy to patients living with multiple myeloma who are in need of a new therapeutic option, Zhuang concluded.

Encouraging Results for Dual-Targeted CAR T-Cell TherapyMore than three out of four patients with multiple myeloma that returned or did not respond to at least two therapies remained in remission seven months after treatment with a novel CAR T-cell therapy targeting two proteins that are frequently found on myeloma cells.

Nine patients experiencing sustained remissions in this study, which ws supported by the National Natural Science Foundation of China, the Major Technological Innovation Special Project fund of Hubei Province of China, and Cellyan Therapeutics, were diagnosed with a difficult-to-treat form of multiple myeloma in which the disease has spread beyond the bone marrow.

Roughly one in 10 patients with multiple myeloma develop tumors in the organs or soft tissues such as the blood vessels, muscles, and nerves. These so-called extramedullary tumors respond poorly to treatment, and patients who develop them have a poor outlook and poor health related quality of life (hrQoL)

Our results show that this CAR T-cell product can effectively achieve elimination of extramedullary tumors, said study author Yu Hu, MD, Ph.D, of Union Hospital, Huazhong University of Science and Technology in Wuhan, China.

Although these are preliminary data, they are encouraging for patients with multiple myeloma who have not responded to other therapies, Hu added.

Hu and his colleagues are developing the first CAR T-cell therapy to be genetically engineered to target BCMA and CD38, two proteins found on the surface of plasma cells. Multiple myeloma is a cancer of plasma cells, which are found in the bone marrow and are part of the immune system, the bodys defense system against infection and disease.

Our thinking was that targeting both of these proteins would improve treatment efficacy without increasing toxicity, and induce deeper, more durable remissions, Hu noted.

The first-in-humans phase I trial enrolled 22 patients whose average age was 59, of whom 11 were men. All had multiple myeloma that had returned or not responded to at least three therapies. Nine of the 22 patients had extramedullary tumors. The study aims were to determine the safest and most effective dose of the CAR T-cell therapy as well as to initially evaluate its effectiveness.

Just like in other trials with CAR T-cell therapies, the participating patients received three days of chemotherapy to make room in their immune systems for the engineered T-cells. Then each patient was infused with the dual-targeted CAR T cells. Patients were divided into five groups, with each group receiving a higher dose than the previous one. Depending on the cell dose, patients received either one or two infusions.

At a median of 36 weeks of follow-up, 18 patients (90.9%) had MRD-negative disease. Twelve patients (54.5%) had a stringent complete response, meaning that no plasma cells were detected in the bone marrow. Seven patients (31.8%) had a good or very good partial response, meaning that the level of M-protein (an abnormal protein produced by cancerous plasma cells) in the blood or urine was reduced but still detectable. In eight of the nine patients with extramedullary lesions, these tumors were undetectable on their computed tomography scans. For the 17 patients who remained in remission at seven months after treatment, the median duration of response was 28.8 weeks.

The adverse events observed included 20 patients who experienced CRS, of whom six needed treatment. No serious adverse neurologic effects such as seizures, movement impairment, difficulty speaking or understanding speech, or fatal swelling in the brain were reported.

With this dual-targeted CAR T-cell therapy, we have demonstrated a high response rate, especially a higher rate and longer duration of stringent complete response, compared with other therapies, as well as effective elimination of extramedullary lesions, with no serious neurologic adverse effects and manageable levels of other adverse effects, Hu concluded.

The investigators continue to follow the patients for the next two years. They are also planning to conduct a phase II trial in both China and the United States to test the treatments effectiveness in a larger number of patients.

Clinical trialsA Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1) NCT03548207

References[1] Srivastava S, Riddell SR. Chimeric Antigen Receptor T Cell Therapy: Challenges to Bench-to-Bedside Efficacy. J Immunol. 2018;200(2):459468. doi:10.4049/jimmunol.1701155 [Abstract][2] Schuster SJ, Bartlett NL, Assouline S, Yoon SS, Bosch F, Sehn LH, Cheah CY, Shadman M, et al. Mosunetuzumab Induces Complete Remissions in Poor Prognosis Non-Hodgkin Lymphoma Patients, Including Those Who Are Resistant to or Relapsing After Chimeric Antigen Receptor T-Cell (CAR-T) Therapies, and Is Active in Treatment through Multiple Lines. 61st annual meeting of the American Society of Hematology. Program: General Sessions. Session: Plenary Scientific Session. Hematology Disease Topics & Pathways: antibodies, Follicular Lymphoma, CRS, Diseases, Biological, Therapies, neurotoxicity, Adverse Events, CAR-Ts, Non-Hodgkin Lymphoma, DLBCL, immunotherapy, Lymphoid Malignancies. [Abstract][3] Goodridge JP, Mahmood S, Zhu H, Gaidarova S, Blum R, Bjordahl R, Cichocki F, et al. FT596: Translation of First-of-Kind Multi-Antigen Targeted Off-the-Shelf CAR-NK Cell with Engineered Persistence for the Treatment of B Cell Malignancies. 61st annual meeting of the American Society of Hematology. Program: Oral and Poster Abstracts. Type: Oral. Session: 625. Lymphoma: Pre-ClinicalChemotherapy and Biologic Agents: Targeting Apoptosis Pathways in Lymphoma.[Abstract][4] Madduri D, Usmani SZ, Jagannath S, Singh I, Zudaire E, Yeh TM, Allred AJ, Banerjee A, et al. Results from CARTITUDE-1: A Phase 1b/2 Study of JNJ-4528, a CAR-T Cell Therapy Directed Against B-Cell Maturation Antigen (BCMA), in Patients with Relapsed and/or Refractory Multiple Myeloma (R/R MM). 61st annual meeting of the American Society of Hematology. Program: Oral and Poster Abstracts. Type: Oral Session: 653. Myeloma: Therapy, excluding Transplantation: Novelty in CAR T in Relapsed/Refractory Multiple Myeloma. [Abstract][5] Li C, Mei H, Hu Y, Guo T, Liu L, Jiang H, Tang L, Wu Y, et al. A Bispecific CAR-T Cell Therapy Targeting Bcma and CD38 for Relapsed/Refractory Multiple Myeloma: Updated Results from a Phase 1 Dose-Climbing Trial61st annual meeting of the American Society of Hematology. Program: Oral and Poster Abstracts. Type: Oral. Session: 653. Myeloma: Therapy, excluding Transplantation: Novel Therapy for Relapsed Myeloma. Hematology Disease Topics & Pathways: Biological, Diseases, Adult, Therapies, Lymphoma (any), Adverse Events, CAR-Ts, Elderly, Biological Processes, Technology and Procedures, Cell Lineage, Study Population, Clinically relevant, Lymphoid Malignancies.

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ASH 2019: Second-gen CAR T-Cell Therapy Overcome Resistance, Reduce Toxicity and Simplify Treatment - OncoZine

The issuance of this patent highlights Lineages dominant position in the field of cell therapy, stated Brian M. Culley, CEO of Lineage. Our efforts to develop new treatments rely on well-characterized and NIH-approved human cell lines. These lines are not genetically manipulated, which avoids the safety concerns associated with genetic aberrations arising from the creation of iPS cells. We believe the Lineage cell lines provide the safest option for our current clinical-stage programs, particularly in immune-privileged anatomical sites such as the eye (OpRegen for the treatment of dry AMD) and spinal cord (OPC1, for the treatment of spinal cord injury). However, the vast intellectual property estate which underlies our cell therapy platform has never been limited to these particular cell lines. As one example, this newly-issued patent provides us with proprietary methods for producing induced pluripotent stem cells, or, as it was practiced by us prior to Yamanaka, Analytical Reprogramming Technology (ART). In certain settings, an ART/iPS approach might offer important advantages, such as for an autologous treatment or when the selection of preferential attributes from a series of iPS lines is desirable. Questions as to which stem cell technology is preferred ultimately will be answered by clinical safety and efficacy and likely will be indication-specific, so we believe it is in the best interest of our shareholders to generate patented technology which enables us to pursue programs in either or both formats which we believe will ensure the highest probability of success.

This patent broadly describes multiple techniques for reprogramming cells of the body back to the all-powerful stem cell state, said Dr. Michael D. West, CEO of AgeX and first inventor on the patent. Perhaps more significantly, it includes certain factors that address some of the difficulties currently encountered with iPS cells. It also reflects the foundational work our scientists have undertaken to apply reprogramming technology to age-reversal, specifically, induced Tissue Regeneration (iTR) which is currently a focus of AgeX product development.

Induced Pluripotent Stem Cells (iPS) are typically derived from adult skin or blood cells which have been reprogrammed or induced to retrace their developmental age and regain the potential to form all of the young cell and tissue types of the body. In 2010 inventors of the -723 patent issued today demonstrated that this reversal of developmental aging even extended to the telomere clock of cell aging. This reprogramming technology provides an alternate source of starting material for the manufacture of potentially any type of human cell needed for therapeutic purposes. Because iPSCs can be derived directly from adult tissues, they can be used to generate pluripotent cells from patients with known genetic abnormalities for drug discovery or as an alternative source of cell types for regenerative therapies.

U.S. Patent No. 10,501,723, entitled Methods of Reprogramming Animal Somatic Cells was assigned to Advanced Cell Technology of Marlborough, Massachusetts (now Astellas Institute for Regenerative Medicine) and licensed to Lineage and sublicensed to AgeX Therapeutics for defined fields of use. Inventors of the patent include Michael D. West, CEO of AgeX and previous CEO of Advanced Cell Technology, Karen B. Chapman, Ph.D., and Roy Geoffrey Sargent, Ph.D.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly-defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeX is developing its core product pipeline for use in the clinic to extend human healthspan and is seeking opportunities to establish licensing and collaboration agreements around its broad IP estate and proprietary technology platforms. For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, Lineages exploration of alternative cell therapy platforms. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 14, 2019 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191210005404/en/

Excerpt from:
Lineage Cell Therapeutics and AgeX Therapeutics Announce Issuance of US Patent for Method of Generating Induced Pluripotent Stem Cells - BioSpace

AgeX Therapeutics, Inc. (NYSE American: AGE) and Lineage Cell Therapeutics, Inc. (NYSE American and TASE LCTX), announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,501,723, entitled "Methods of Reprogramming Animal Somatic Cells" covering what is commonly designated "induced Pluripotent Stem (iPS) cells. The issued claims include methods to manufacture pluripotent cells capable of becoming any cell in the body. The patent has an early priority date, having been filed before the first scientific publication of Shinya Yamanaka, for which he won the Nobel Prize for Physiology or Medicine in 2012.

"This patent broadly describes multiple techniques for reprogramming cells of the body back to the all-powerful stem cell state," said Dr. Michael D. West, CEO of AgeX and first inventor on the patent. "Perhaps more significantly, it includes certain factors that address some of the difficulties currently encountered with iPS cells. It also reflects the foundational work our scientists have undertaken to apply reprogramming technology to age-reversal, specifically, induced Tissue Regeneration (iTR) which is currently a focus of AgeX product development." A video describing the significance of the patent in AgeXs product development is available on the AgeX website.

"The issuance of this patent highlights Lineages dominant position in the field of cell therapy," stated Brian M. Culley, CEO of Lineage. "Our efforts to develop new treatments rely on well-characterized and NIH-approved human cell lines. These lines are not genetically manipulated, which avoids the safety concerns associated with genetic aberrations arising from the creation of iPS cells. We believe the Lineage cell lines provide the safest option for our current clinical-stage programs, particularly in immune-privileged anatomical sites such as the eye (OpRegen for the treatment of dry AMD) and spinal cord (OPC1, for the treatment of spinal cord injury). However, the vast intellectual property estate which underlies our cell therapy platform has never been limited to these particular cell lines. As one example, this newly-issued patent provides us with proprietary methods for producing induced pluripotent stem cells, or, as it was practiced by us prior to Yamanaka, Analytical Reprogramming Technology (ART). In certain settings, an ART/iPS approach might offer important advantages, such as for an autologous treatment or when the selection of preferential attributes from a series of iPS lines is desirable. Questions as to which stem cell technology is preferred ultimately will be answered by clinical safety and efficacy and likely will be indication-specific, so we believe it is in the best interest of our shareholders to generate patented technology which enables us to pursue programs in either or both formats which we believe will ensure the highest probability of success."

Induced Pluripotent Stem Cells (iPS) are typically derived from adult skin or blood cells which have been "reprogrammed" or "induced" to retrace their developmental age and regain the potential to form all of the young cell and tissue types of the body. In 2010 inventors of the -723 patent issued today demonstrated that this reversal of developmental aging even extended to the telomere clock of cell aging. This reprogramming technology provides an alternate source of starting material for the manufacture of potentially any type of human cell needed for therapeutic purposes. Because iPSCs can be derived directly from adult tissues, they can be used to generate pluripotent cells from patients with known genetic abnormalities for drug discovery or as an alternative source of cell types for regenerative therapies.

U.S. Patent No. 10,501,723, entitled "Methods of Reprogramming Animal Somatic Cells" was assigned to Advanced Cell Technology of Marlborough, Massachusetts (now Astellas Institute for Regenerative Medicine) and licensed to Lineage and sublicensed to AgeX Therapeutics for defined fields of use. Inventors of the patent include Michael D. West, CEO of AgeX and previous CEO of Advanced Cell Technology, Karen B. Chapman, Ph.D., and Roy Geoffrey Sargent, Ph.D.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly-defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeX is developing its core product pipeline for use in the clinic to extend human healthspan and is seeking opportunities to establish licensing and collaboration agreements around its broad IP estate and proprietary technology platforms.

Story continues

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its proprietary cell-based therapy platform and associated development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally-differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed either to replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical assets include (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase I/IIa development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase I/IIa development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic cancer immunotherapy of antigen-presenting dendritic cells currently in Phase I development for the treatment of non-small cell lung cancer. Lineage is also evaluating potential partnership opportunities for Renevia, a facial aesthetics product that was recently granted a Conformit Europenne (CE) Mark. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Certain statements contained in this release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates" should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the "Risk Factors" section of AgeXs Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20191210005435/en/

Contacts

Media Contact for AgeX:Bill Douglass Gotham Communications, LLCbill@gothamcomm.com (646) 504-0890

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AgeX Therapeutics and Lineage Cell Therapeutics Announce Issuance of U.S. Patent for Method of Generating Induced Pluripotent Stem Cells - Yahoo...

Lineage Cell Therapeutics and AgeX Therapeutics have been awarded a United States Patent and Trademark Office patent for Methods Of Reprogramming Animal Somatic Cells.

The issuance of this patent highlights Lineages dominant position in the field of cell therapy, stated Brian M. Culley, CEO of Lineage. Our efforts to develop new treatments rely on well-characterized and NIH-approved human cell lines. These lines are not genetically manipulated, which avoids the safety concerns associated with genetic aberrations arising from the creation of iPS cells. We believe the Lineage cell lines provide the safest option for our current clinical-stage programs, particularly in immune-privileged anatomical sites such as the eye (OpRegen for the treatment of dry AMD) and spinal cord (OPC1, for the treatment of spinal cord injury). However, the vast intellectual property estate which underlies our cell therapy platform has never been limited to these particular cell lines. As one example, this newly-issued patent provides us with proprietary methods for producing induced pluripotent stem cells, or, as it was practiced by us prior to Yamanaka, Analytical Reprogramming Technology (ART). In certain settings, an ART/iPS approach might offer important advantages, such as for an autologous treatment or when the selection of preferential attributes from a series of iPS lines is desirable. Questions as to which stem cell technology is preferred ultimately will be answered by clinical safety and efficacy and likely will be indication-specific, so we believe it is in the best interest of our shareholders to generate patented technology which enables us to pursue programs in either or both formats which we believe will ensure the highest probability of success.

This patent broadly describes multiple techniques for reprogramming cells of the body back to the all-powerful stem cell state, said Dr Michael D West, CEO of AgeX and first inventor on the patent. Perhaps more significantly, it includes certain factors that address some of the difficulties currently encountered with iPS cells. It also reflects the foundational work our scientists have undertaken to apply reprogramming technology to age-reversal, specifically, induced Tissue Regeneration (iTR) which is currently a focus of AgeX product development.

Patent 10,501,723 covers induced pluripotent stem cells which includes methods to manufacture iPSs cells that are capable of becoming any cell within the body. This patent has an early priority date having been filed before the first scientific publication, and was assigned to Advanced Cell Technology of Marlborough, Massachusetts and licenced to Lineage as well as being sublicensed to Age X for defined fields of use.

See more here:
Patent Granted To Lineage & AgeX - Anti Aging News

Men are nearly two times more likely to develop blood clots while undergoing testosterone therapy, according to University of Minnesota research.

The study, which was published last month, found that men on testosterone therapy were at a heightened risk of developing a condition commonly known as VTE. With this condition, blood clots form in the veins and travel to the lungs, potentially blocking the blood supply. Men seek testosterone therapy for a variety of reasons, including low testosterone levels and sexual dysfunction.

These findings were shown in both men with and without hypogonadism, a condition where the body does not produce enough testosterone naturally.

There hasnt really been [this] kind of care given to a hypogonadism diagnosis. A lot of other studies either control for it or restrict it to one specific group of men, said Robert Walker, the study's lead and a research assistant at the Universitys Minnesota Population Center.

In the study, researchers separated men with the condition and men without it. By doing so, they were able to see a near doubling of risk in both groups, he said. They were also able to control for factors such as smoking status, obesity and race.

Overall for Americans, there [are] about 1 million cases of VTE annually, Walker said, which includes a lifetime risk of one in 12 people. Symptoms include leg pain, swelling and rashes.

While men typically receive testosterone therapy for hypogonadism, they may also seek it for unwanted weight gain or emotional regulation.

"These findings are important, particularly for the men with no hypogonadism, as they suggest that off-label testosterone use for symptoms of 'male menopause' may be causing harm, said Pamela Lutsey, a co-author of the study and University associate professor in the Division of Epidemiology and Community Health, in an email to the Minnesota Daily.

When men seek testosterone therapy for reasons other than hypogonadism, there is not necessarily an official diagnosis. However, treatment could fix those symptoms, Walker said.

Testosterone therapy is more than just a kind of stroke and heart failure risk factor, we have to take into account other cardiovascular symptoms, he said.

In the future, the researchers can use the same study design to test the effects of testosterone therapy on women, Walker said.

Women who need to take testosterone for one reason or another may also be put at a risk, he said.

Women are often at risk of developing VTE while pregnant because of the pressure on their organs or afterward in the postpartum period, Walker said.

An important next step is for other researchers to reproduce these results, said Richard MacLehose, another co-author of the study and University associate professor in the Division of Epidemiology and Community Health.

Walker said he began this study because of the lack of research papers on the effects of testosterone therapy.

The story of the paper is really just to think before you prescribe, he said.

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Men who receive testosterone therapy nearly twice as likely to develop blood clots, researchers find - Minnesota Daily

NORTHBROOK, Ill., Dec. 11, 2019 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc. today announced the appointment of five senior leaders, each of whom bring valuable industry and category experience to the team. Together they strengthen the companys commercialization capability for JATENZO (testosterone undecanoate) capsules, the first-in-class oral testosterone replacement therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypogonadism. See indication and important risk information, including boxed warning below.

Dr. Newmark, Mr. Jaeger, Mr. Rodriguez, Ms. Wright and Mr. Holloway join a management team led by Robert Dudley, Ph.D., Clarus Therapeutics Chief Executive Officer and co-inventor of JATENZO. Dr. Dudleys legacy in mens health includes CEO leadership of the company that developed and launched AndroGel, a product he co-invented and the last major advancement in testosterone replacement therapy delivery.

We are proud to bring Jay, Frank, Jose, LaTonya, and James into an organization that shares their focus on innovation and excellence. They have each demonstrated an ability to connect with medical professionals who are invested in mens health, said Dudley. Their expertise will help us make the long sought-after oral testosterone option widely available to appropriate hypogonadal men.

INDICATION

JATENZO (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Limitation of use

Safety and efficacy of JATENZO in males less than 18 years old have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: INCREASES IN BLOOD PRESSURE

CONTRAINDICATIONS

JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.

WARNINGS AND PRECAUTIONS

ADVERSE EVENTS

The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.

There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.

Please see accompanying full Prescribing Information, including BOXED WARNING on increases in blood pressure.About JATENZO JATENZO is a first-in-class proprietary oral soft gel formulation of testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

JATENZOs proprietary formulation is built around testosterone undecanoate a testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigation of its oralTestosteroneUndecanoate) clinical trial, 87% (n=222) of men treated with JATENZO achieved average circulating levels of testosterone in the normal range for men.

About Clarus Therapeutics, Inc.Clarus is a men's specialty pharmaceutical company developing and preparing for the commercial launch of JATENZO, a product protected by patents issued in the United States and in other major pharmaceutical markets around the world. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO.For more information, please visit:www.clarustherapeutics.com.

Media ContactAmir KhanPhone: (212) 462-8767Email: Amir.Khan@Syneoshealth.com

2019 Clarus Therapeutics, Inc. All rights reserved.

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Clarus Therapeutics Expands Executive Team in Preparation for Landmark Launch of JATENZO (testosterone undecanoate) Capsules CIII - GlobeNewswire

She only appeared in the pilot!

Who is Hosanna Plath? That's been the question on everybody's mind since Welcome to Plathvilledebuted on TLC, the network that once focused on things like childbirth and dinosaur bones, but now focuses on messy relationships, hypogonadism, multiple birth families, and metabolic issues with their accompanying bariatric procedures. So what makes Hosanna Plath stand out from the rest of the Plath clan?

RELATED:Meet The 9-Kid, No-Technology Plath Family Featured In New TLC Show 'Welcome To Plathville'

Welcome to Plathvilleis the latest TLC reality show that focuses on a family that most would consider "strange and unusual." The Plath family led by matriarch Kim and patriarch Barry say on the show they are "devout Christians," and though they don't get into detail about which denomination of Christianity they follow, there are some photos of the family posing in front of a Baptist church. What makes them remarkable, however, is not their adherence to Christianity, but their practice of isolating their children from pop culture. In many of the previews for the show, for example, viewers are left to marvel as the Plath children Hosanna included are left to wonder who people like Justin Bieber and Tom Brady really are.

That said, though the family has no exposure to pop culture, they do have a YouTube channel that promotes their gospel music. Each family member plays an instrument, so let's look at the violinist, Hosanna Plath.

Though Hosanna Plath has an older brother, Ethan who is the officialoldest of the Plath children she's the oldest Plath daughter. She is one of 9 children and would have been one of 10 had her younger brother, Joshua, not been killed in a tragic accident.

Hosanna Plath is known, in her family band, for playing the violin. She's an accomplished violinist and actually turned down going to college to continue to play the violin. (Since she married her husband, Timothy Noble, she's also played as a duet with him.)

In theWelcome to Plathvillepilot, it was revealed that Hosanna Plath had a musical scholarship to college, but turned it down to continue to play with the family band. This decision drew some fire from the fandom, especially since it was later revealed that Kim Plath the matriarch of the family graduated from FSU.

RELATED:Meet Nail Artist Lexi Martone Star Of The New TLC Reality Series 'Unpolished'

In 2016, Hosanna Plath went to the National Quartet Convention. And it was there that she met Timothy Noble, the man who would become her husband. Noble plays piano, and he often plays together with his wife as a duet. They dated for two years before they ultimately got married in June 2019.

According to reports, there'stension within the family because Hosanna Plath was considered the "musical prodigy" of the family. Because she's so talented and accomplished, Hosanna Plath reportedly taught her siblings how to play their respective instruments. So when Hosanna married Timothy and the duo moved to Ohio thus, away from the family the Plath family band seemed to languish. As such, rumors began circulating that there was a fracture in the Plath family.

Sometimes, it really is the devil you know. While therecertainl, is no shortage of people who criticize the Plath family for raising their children including Hosanna Plath so strictly, there are some good reasons for their method. As revealed on the show, Kim Plath drew a hard line against having alcohol served at her son, Ethan's, wedding, because she admitted she was a recovering alcoholic. Her biggest fear, she said, was that her children would walk down the same path that she walked down.

While, no doubt, that is a bit extreme, we can certainly understand the desire to protect your children. We look forward to hearing more from Hosanna Plath in the future.

RELATED:Meet Kim Plath Controversial Matriarch Of Family Raising 9 Kids Technology-Free On TLC's 'Welcome To Plathville'

Bernadette Giacomazzo is an editor, writer, and photographer whose work has appeared in Teen Vogue, People, Us Weekly, The Source, XXL, HipHopDX, The Los Angeles Times, The New York Post, BET.com, and more. She is also the author of The Uprising series and is the CEO of the acclaimed G-Force Marketing & Publicity firm, which has been featured in The Hollywood Reporter and has scored film, television, radio, and print placements for celebrity clientele worldwide.

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Get To Know Hosanna Plath, The 'Welcome To Plathville' Star And Accomplished Violinist - YourTango

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Press Release updated: Dec 11, 2019 15:00 EST

LOS ANGELES, December 11, 2019 (Newswire.com) QY Research has lately come up with a new report titled, Global Hormone Replacement Therapy Market Report, History and Forecast 2014-2025, for the projected period of six years, i.e. between 2019 and 2025. The reports states that the global Hormone Replacement Therapy market was valued at US $15.7 billion in 2018 and is expected to reach US $17.4 billion by the end of 2025. The global market is anticipated to register a sluggish CAGR of 1.5% from 2019 to 2025.

Request a Sample Copy of this Report athttps://www.qyresearch.com/sample-form/form/1123650/global-hormone-replacement-therapy-market

Factors Hampering the Growth of the Global Hormone Replacement Therapy Market

Medical Conditions and Healthcare:Lack of awareness amongst patients regarding hormone deficiencies and imbalances, resulting in serious conditions such as menopause and hypothyroidism, is expected to hamper the growth of the market.

Drugs and Pharmaceuticals:Lack of drug delivery systems, particularly in developing economies and the high cost of therapies and potential side effects are anticipated to restrain the growth of the market.

Risk of Cancer and Heart Disease:Uncertainty among doctors for prescribing Hormone Replacement Therapy due to the risk of heart disease and breast cancers is likely to obstruct the growth of the market.

Availability of Alternate Options A Significant Factor Obstructing Growth

The type segment is further sub-segmented into growth hormone, Estrogen Hormone, Testosterone Hormone, and thyroid hormone. Based on application, the segment is bifurcated into

Due to premature birth resulting in underdevelopment in infants, treatments for growth hormone deficiency has witnessed considerable demand over the years. Increasing awareness among women regarding menopause is likely to boost the growth of the application segment. However, the availability of alternative options in the market, along with the presence of various brands and generic drugs, are likely to impede the growth of the market.

Prevalence of Hormone Related Diseases Likely to foster Regional Market

The global market is bifurcated into Asia-Pacific, Europe, North America, Central America, Middle-east, and Africa. Asia-Pacific is likely to hold a considerable share of the market due to the presence of a huge population and an increase in the prevalence of conditions such as hypothyroidism, menopause, hypogonadism, and hormone deficiency.

Innovation and Product Development A Major Emphasis of Key Players

Some of the top players operating in the market are Pfizer, Eli Lilly, Novo Nordisk, AbbVie, Merck, Bayer, KGaA, Mylan, Novartis, Teva, Abbott, Roche, Ipsen, Endo International, TherapeuticsMD, and ANI Pharmaceuticals. Top players of the market are inclined to incorporate advanced technology and to collaborate for offering innovative products.

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Global Hormone Replacement Therapy Market is Anticipated to Reach US $17.4 Billion by the End of 2025 - The Chestnut Post

An increasingly common question I get asked is, Will gene testing help my doctor know which antidepressant to prescribe? Popular tests such as GeneSight suggests that they can shorten your road to recovery and how you, as an individual, will respond to specific antidepressant medications.

Does drug-gene testing, also referred to as pharmacogenomics or pharmacogenetics, work? And if so, does it only work for certain types of medications? Lets find out.

The idea of gene-drug testing is pretty simple. By testing your DNA, companies hope to be able to predict your response (or likely non-response) to specific types of antidepressants. Its also being marketed for a number of other diseases and medications.

Just a year ago, GeneSight had some pretty strong marketing language on its site. The company was strongly suggesting its test could help your doctor choose the best antidepressant for you:

Fortunately, the GeneSight genetic test can provide doctors answers that quickly lead to relief. Pharmacogenomic testing helps empower your doctor with the exact information needed to prescribe you the best medication for you. By examining how your DNA responds to specific medications such as antidepressants, this simple, painless test lets doctors know which medications may not work for you, so you can get back to feeling like yourself again. [] Through pharmacogenomic testing, your doctor can identify the correct medication and create a personalized treatment for you.

In the 2018 announcement of its own antidepressant test, another gene-drug testing company called Color says it now analyzes a number of these genes, starting with two that can impact your response to certain mental health medications like Zoloft, Paxil, and Lexapro. The blog entry cites seven research studies, but none of them have anything to do with antidepressants.

Few genetic researchers feel as positive about the current usefulness of gene-drug testing than companies marketing these tests. The American Psychiatric Associations research council reviewed the evidence last year and found that such genetic testing is not really ready for mass consumption.

Greden et al. (2019) looked at using pharmacogenomics directly to help in depression treatment. Because the researchers didnt find a significant difference (either statistically or clinically) in their primary outcome measure, they instead emphasized the statistical significance they found in two of the 25 secondary outcome measures they examined.

In treatment research, scientists increasingly use a statistic called Number Needed to Treat (NNT) that allows for cross-comparisons of the real-world efficacy of different kinds of treatment. The National Institute for Clinical Excellence (NICE) in the UK recommends that for a treatment to be clinically significant, the NNT should be in the single digits.

According to a critique of the researchers (Goldberg et al., 2019), the Greden study had an NNT of 17 for a response to an antidepressant and an NNT of 19 for remission of a depressive episode. Not exactly powerful numbers. In fact, combined with the non-significance of the primary outcome studied, Greden ironically demonstrated that pharmacogenomics doesnt appear to very good at its primary goal of helping to guide antidepressant treatment.

In short, the science today doesnt support the mainstream use of these tests for antidepressants.

Personalized medicine is the new New Thing marketed by anyone who has access to a DNA lab. The problem is that the marketing of gene-drug testing far overshadows the science. In early 2019, the U.S. Food and Drug Administration updated its guidance on gene-drug testing:

[The] FDA is aware of genetic tests that claim results can be used to help physicians identify which antidepressant medication would have increased effectiveness or side effects compared to other antidepressant medications. However, the relationship between DNA variations and the effectiveness of antidepressant medication has never been established. []

Do not change or stop taking any medicine based on a report from a genetic test you took on your own. []

[And to doctors:] If you are using, or considering using, a genetic test to predict a patients response to specific medications, be aware that for most medications, the relationship between DNA variations and the medications effects has not been established.

Goldberg et al. (2019) said it best:

[Researchers] have noted that commercial [] test manufacturers promote their products with a zeal that is disproportionate to the existing evidence base particularly when marketing to the lay public and clinicians who are likely unfamiliar with the limited statistical power of candidate gene association studies.

Youd be wasting your money by purchasing one of these tests in hopes of getting better results from your antidepressant treatment. The science simply doesnt support use of these tests at this time.

Online health information isnt always accurate on this issue even from trusted sources. For instance, the Mayo Clinic suggest these tests can help, but its unclear whether the anonymous, unlisted author of that article has examined the primary research (as there are no research references listed in the article). Harvard Health Publishing, on the other hand, got it right by noting that the research of gene-drug testing showed no evidence of effectiveness.

Someday, the hope is that pharmacogenetics may meaningfully inform treatment decisions, as it does in oncology. But were not yet there.

References

Goldberg, J.F., Rosenblat, J.D., McIntyre, R.S., Preskorn, S.H., de Leon, J. (2019). Letter to the Editor: Clinical versus statistical significance of pharmacogenomic-guided antidepressant therapy: Whats really being measured and marketed? Journal of Psychiatric Research, 114, 208-209.

Greden, J.F., Parikh, S.V., Rothschild, A.J., et al. (2019). Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: a large, patient-and rater-blinded, randomized, controlled study. J. Psychiatr. Res. 111, 5967. https://doi.org/10.1016/j.jpsychires.2019.01.003

Related Articles

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Gene Testing for Antidepressants & Psychotropics: Not There Yet - PsychCentral.com

The public called it bubble boy disease. Until recently, any infant born with this rare genetic disordera mutation called severe combined immunodeficiency (SCID-X1), linked to the X chromosomehad little chance of surviving outside a small, sterile environment. Brian Sorrentino, a hematologist and gene therapy researcher at St. Jude Childrens Research Hospital in Memphis, Tennessee, made it his lifes mission to cure this disease.

Sorrentino died at 60 in November 2018, before the groundbreaking results of the first trial were published in The New England Journal of Medicine. As a teenager, Sorrentino had been treated for Hodgkins lymphoma, with heavy doses of radiation. This led to various other ailments later in life, including heart disease and then terminal lung cancer.

He felt like there was a reason that he was saved at 17, says his widow, Suzanne Sorrentino, who also lost her first husband to lung cancer. The work he did to save patients with bubble boy disease was it.

The team thats now carrying on Sorrentinos work at St. Jude won the 2019 Smithsonian magazine American Ingenuity Award in the life sciences category. We spoke with his widow to learn more about the man who started it all. A condensed interview is below.

Can you tell us a bit about your husbands background and what brought him to St. Jude?

Brian was from New York. His dad was a radiologist, and he thought being a doctor would be the greatest profession in the world. After medical school, he worked at the National Institutes of Health with Dr. Arthur Nienhuis. When Dr. Nienhuis came to Memphis to be the head of St. Jude, Brian came with him. That was in 1993. It took Brian some time to adjust to the South. During the years I knew him, we were still working on getting him to say yall instead of you guys.

He was divorced, and the father of two grown children, when I met him just over five years ago. Id never met a scientist before. I told him, I just picture you in a lab coat looking at a microscope all day. He told me that was part of it, but it was a lot more than that.

Was he able to experience the joy of seeing his work on SCID-X1 come to fruition?

Oh, yes. When they got started with the trial, he was so excited. He and [fellow St. Jude researcher Dr.] Ewelina [Mamcarz] were just giddy when they had some children enrolled.

Its one thing to be in your lab and think youve got it. But to go over and see the child and see the parents who are just desperate, it made it real. He said some of the greatest days to him were when he got to leave his lab, his part of St. Jude, and go over where the patients are.

When Brian died, they had treated 10 patients, and theyd come from all over the world. In one of my favorite pictures of him, hes holding one of the children and hes got the biggest smile on his face.

Whats it like to watch the legacy of his work unfold and get celebrated?

Its bittersweet. Brian would say, Recognition is really nice, but its not important. Whats important is the science and saving these children. He didnt live to see the paper about the trial published in the New England Journal of Medicine, but he did know that it had been accepted.

When the paper came out in April, there was so much hubbub about it. The St. Jude PR department was just overwhelmed. They thought it would be big, but not as big as it turned out to be. I think Brian would have been a little embarrassed. St. Jude had a symposium to honor Brian and one of his colleagues in June. It was really lovely, but I just think, Damn it, he should be here!

Beyond scientific research, what were some of Brians other passions?

He played guitar. At a big, nice, fancy St. Jude dinner, with everybody all dressed up, he got up onstage and played Mustang Sally with the band that was performing. He was so nervous. I got so sick of that song. Hed played it a thousand times before the dinner because he didnt want to mess up in front of his colleagues.

He loved the Grateful Dead, which I never understood. I went to four Grateful Dead concerts with him, and told him, You owe me. This music is awful. I like music that has a beginning and an end. He would try to explain how wonderful it was. We buried him in a Jerry Garcia T-shirt.

He also loved his Corvette. He drove it on weekends, and that was his fun car. He had a Volkswagen that he would drive to work that he called his beater. He would get in that beater and drive like he was 85 years old. Hed get in his Corvette and go 100 miles an hour. At the symposium St. Jude had to honor him, everybody who spoke, including the head of the hospital, got up and had some horror story of riding with Brian in his Corvette.

He was just witty and wonderful. And there was a whole new world for me when I met him.

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Honoring the Legacy of Brian Sorrentino | Innovation - Smithsonian.com

Twelve-year-old Ash Lammin, who was born a boy, is one of Britains youngest transgender children (Picture: KMG /SWNS.COM)

Ash Lammin says she felt that she was a girl as soon as she could speak.

The 12-year-old, from Kent, says that it has been difficult growing up as a transgender girl but feels that she is firmly on the right path.

Now Ash is beginning to transition her gender from male to female at an NHS-run clinic and is one of the youngest children in the country to do so.

Ash who changed her name by deed poll to Ashley when she was eight will start by taking hormone blockers to halt the onset of puberty.

She eventually wants a womb transplant so she can be a mother when she is older.

She said: The journey is long and its still going, but I feel like the sense of victory is there through it all. I do feel accepted sometimes, but other times not.

Not everyone is going to understand and people have to have their own opinions and I understand that. Some people might not like the idea of trans.

I hope I inspire others but I just hope that love and acceptance comes through everything.

Mum Terri has said that Ash will take the blockers until she is 18. At that point, she herself will decide whether to go ahead with gender reassignment surgery.

If she decides not to go ahead with it, Ash will come off the blocker, and her puberty will kick in just a few years later than her peers.

She said: I never thought it was a phase, Ash was just Ash. When she was three she said to me, Im a boy because you gave me a boys name its your fault.

I remember feeling horrible, because she blamed me.

Id never come across it before and I just went along with it. I just thought at the time if hes happy, well thats the main thing.

When Ash turned 11 and went to secondary school, she became a target for bullies who would throw things at her on the bus and shout abuse at her, forcing Terri to take her out of the school after just one term.

Ash is now being home-schooled and Terri is calling for better education within schools to teach children about transgender people.

She said: Id like to see the subject of transgender people included in some lessons, like there are about same-sex families.

There needs to be more about liking people for who they are, not what they are.

MORE: Transgender teen has penis farewell party before gender reassignment surgery

MORE: Transgender man is asked to go as a bridesmaid to mothers wedding despite identifying as a guy

MORE: Transgender teen has penis farewell party before gender reassignment surgery

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12-year-old transgender preteen has started transitioning - Metro.co.uk

December 10, 2019 Cover

Off-road racing has always been a big part of the Laughlin event scene. Drivers of heavy duty racing trucks and buggies like the challenge of negotiating hairpin turns and switch-backs over a rugged desert course, daring them to take their skills to the next level which is why the 2019 McKenzies Rage at the Rivers season finale is a popular event.

When it comes to portraying Johnny Cash, tribute artists dont get much closer than Shawn Barker.Cash commanded and earned the kind of serious respect that continues long after his passing, and Barker has kept that respect at the very core of everything he does from the very beginning. Sure, an artist might include the kind of fun Cash used to have, because they know full-well his fans expect nothing less.

If anyone knows about the healing power of laughter, its Will C, a.k.a. William Clifton, because hes seen it happen.The veteran of both comedy and American armed forces, Will C lives by his message that laughter is truly the best medicine.On a dare he took the stage at the World Famous Comedy Store in La Jolla, California, in the spring of 1995. He caught the comedy bug and never looked back.

A sip of Cella wine is all it takes to taste the heart and soul that goes into crafting each blend at the Kingman winery and vineyard.For Carlos Cella, owner of Cella Wines, the craft is his passion, and it is evident in the high-quality flavor and aroma that bursts from every bottle.Cella has been making wines since childhood with his Italian upbringing.

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Reviews of female viagra - Fox news female viagra - Is there a female viagra yet - Laughlin Entertainer

Many of us biologists conduct fieldwork in diverse places, from Alaska to the tropics, from aiming to understand how microbes are responding to climate change in the boreal soils to learning about life history strategies and co-evolutionary arms races of bats, their ectoparasitic flies, and the ectoparasitic fungi living on those flies.

The days before fieldwork tend to be hectic: make a checklist to make sure you have everything you need, think about a plan B (and a plan C, just in case), anticipate drawbacks and plan on how to address them, and the list goes on and on. The day comes. You make it to your field site, you collect the samples you want, obtain the data you need, everything works out just like planned, and you make it back to the lab safe, on time, and without going over your planned budget. This is how it should be, but it never really goes like that.

Fieldwork is one of the most exciting experiences about doing research. It is also, in many cases, high-risk. During fieldwork, many things can go wrong, and most of those things cannot be helped. We cannot control the appearances of massive puddles in the middle of the road, critically damaging our transportation vehicles. We cannot control the thunderstorm that makes our study organisms disappear when we finally arrive at a remote field site after hours of climbing a mud-covered mountain.

Sadly, this is not always the case for threats to our integrity as human beings, and we, as a scientific community, have done far too little to address this problem. People from underrepresented groups in the sciences such as people of color, women, and those who identify as LGBTQIA+ or gender nonconforming often are at higher risk of suffering abuse during fieldwork. This comes in the form of sexual harassment, sexual abuse, discrimination, and intimidation. Scientists who have experienced abuse often fear talking about it because they are traumatized and because they fear retaliation and backlash, especially if the perpetrators of abuse are colleagues or superiors advisers and people at higher career stage.

In Spring 2018, we carried out an anonymous survey to collect testimonies of what scientists, specifically from the LGBTQIA+ community, experience during fieldwork. The idea for such a survey sprouted from concerns that sexual orientation or gender identity may play an unwanted or unwarranted role in peoples professional career. Especially during fieldwork, when Diversity and Inclusion Offices from our university campuses are far away, LGBTQIA+ researchers are exposed to people who may not agree with their sexual orientation or who do not understand why he may want to be addressed as they.

Responses revealed experiences ranging from discrimination to situations that made researchers decide to no longer perform fieldwork outside of safe places. This adds a whole new level to fieldwork stress, namely having to evaluate sites for their tolerance towards LGBTQIA+. In one story from fieldwork, men voiced discomfort because an openly gay man would share a room with them while, simultaneously, women felt uncomfortable due to the possibility of having to share a room with someone from the opposite sex. Another survey respondent described that they were fearful to carry out fieldwork in places that are recognized for their homophobic culture. These experiences leave people feeling isolated and rejected.

We present a few strategies that we can instill in STEM fields to avoid cases like these:

1) INFORM PEOPLE ABOUT LGBTQIA+. Erase any misinformation that may exist. For example, a gay man is not a threat to the sexuality of cisgender males. Institutions can facilitate trainings on diversity and inclusiveness and provide information on the LGBTQIA+ community to eliminate negative stereotypes.

2) HAVE SUFFICIENT FUNDING AVAILABLE FOR FIELDWORK. Although sometimes it's unavoidable to share rooms due to limited budget or space, if there is the possibility to do so, provide individual lodging for people traveling to fieldwork or conferences. Especially for those who ask for it.

3) DEVELOP AN EMERGENCY PROTOCOL. As a lab, department, or institution, develop a protocol that scientists can follow as a response to experiencing a threat to their integrity. Protocols like this should be part of a broader departmental or university-wide mission statement about equity in field work. The bar has been set high by this example of a mission statement written by University of California Irvine professor Kathleen Treseder.

4) AVOID INTOLERANT AREAS. It is important to note that this does not only apply to countries like Niger and Tunisia where discriminatory laws expose LGBTQIA+ individuals to the risk of death penalty. It also applies close to home, in the USA, where there is an ongoing debate about public restrooms and which one transgender people and people who identify as gender-nonconforming should use.

5) IMPLEMENT A ZERO-TOLERANCE POLICY. Inform everyone in your lab, department and institution that there is a zero-tolerance policy regarding abuse. A code of conduct with expected versus unaccepted behavior and practices should always be made available through trainings and in field stations.

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Your Apple smartwatch may be the key to detecting heart issues before they happen - Massive Science

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

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

DUBLIN--(BUSINESS WIRE)--The "Global Cancer Diagnostics Market Analysis: Emerging Opportunities in the USA, Europe, Japan-Supplier Shares and Strategies, Latest Tumor Markers, Volume and Sales Segment Forecasts, Technology and Instrumentation" report has been added to ResearchAndMarkets.com's offering.

The new report is a study of the major business opportunities emerging in the global cancer diagnostics market during the next five years. The report examines trends in the U.S., Europe and Japan; reviews current and emerging assays; analyzes potential applications of new diagnostic technologies; forecasts sales of major tumor markers by country and market segment; profiles leading players and potential market entrants; and identifies specific business opportunities for suppliers.

Rationale

The cancer diagnostics market is on the verge of explosion, as the researchers approach major technological breakthroughs in tumor diagnosis and therapy, discover new specific antigens, and unlock the mystery of the genetic basis of the disease. During the next five years, the worldwide cancer diagnostics market is promising to be an exciting, dynamic and rapidly expanding field.

Anticipated technological breakthroughs will create numerous opportunities for determining genetic predisposition, detecting specific tumors, and monitoring biological response to cancer therapy. The rise in geriatric population will further compound the growing demand for malignancy assays and the rapid market expansion worldwide.

Worldwide Market Overview

Business Opportunities and Strategic Recommendations

Over 200 Current and Emerging Cancer Diagnostic Test

Supplier Shares, Sales and Volume Forecasts

Five-year test volume and sales forecasts for major tumor markers by country and market segment, including:

Instrumentation Review

Technology Assessment

Competitive Strategies

The companies analyzed in the report include:

For more information about this report visit https://www.researchandmarkets.com/r/vxuvz9

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Global Cancer Diagnostics Market Report 2019: Emerging Opportunities, Supplier Shares, Strategies, Latest Tumor Markers, Volume and Sales Segment...

The human immune system is highly complex and multi-faceted. Seemingly an infinite number of things can affect our internal landscape and alter how our immune system defenses respond to and fight foreign invaders to keep us healthy. The misconception a lot of people have is thinking that we want a super active immune system that is like Rambo, an ultimate killing machine! Really what we want is a balanced immune system, that neither swings into hyperactivity nor falls into decreased function. If our immune system functions too high, we end up with autoimmune disorders this is when the immune system attacks our bodys cells, not just foreign invaders, if it is not functioning as it should, when exposed to germs we get sick and have to fight off an illness.

Did you know that just the time of year can affect our immune system function? Just the fact that the daylight does not last as long can cause our immune system to be less responsive. Shorter days and colder weather cause people to stay inside more, reducing the amount of natural vitamin D they make, which is a key immune system booster. An alternative for the individual not wanting to go outside is supplementing Vitamin D into their diet.

See more here:
Seasonally Decreased Immune Function Around the Holidays - Matthews Beacon

Disrupted sleep, irritability, sweats, rapid heart rate 67-year-old Nora Barler has battled extreme hot flashes for three decades, ever since having a total hysterectomy in her late 30s to remove her uterus and ovaries.

When her hot flashes began, she was working in human resources as a labor and employee relations manager and felt self-conscious when one would strike during meetings. I was in meetings with high-level executives, at times the only woman, and I would start sweating up a storm. Beads of sweat would be dripping into my contact lenses, burning my eyes and [running] down my face. My makeup would be smearing. I could feel my heart going boom, boom, boom, she recalls.

The hot flashes also regularly struck at night, despite Barler enlisting central air conditioning, a window unit in the bedroom and two fans. When they were really bad at night, I used cold packs I kept in the freezer. It sounds over the top, but thats how it often was. My husband was freezing, and I kept him awake. And because I didnt sleep, I was exhausted when I went to work. I was irritable and antsy.

Hot flashes during menopause are a fact of life for most women. They come on rapidly and then spontaneously resolve after a few minutes, explains Barbara Soltes, MD, a gynecologic endocrinologist at Rush University Medical Center.

[Women] feel a sensation of heat or a flush over the upper part of their bodies, which subsides in minutes and is followed by perspiration down their face, she says. It is associated with an increase in heart rate and skin temperature, which also subsides in minutes.

Hot flashes during the day can interrupt work or other activities. At night, they can disrupt sleep, which can kick off a cascade of complications: lower energy levels, lower cognition levels, fatigue and irritability. Hot flash symptoms can persist for seven to 11 years or more, according to the long-term Study of Womens Health Across the Nation (SWAN).

Treatment options include:

Estrogen replacement is very effective at easing hot flashes, but women should discuss hormone replacement therapy with their physician because of the risks. Research has found that women who used hormone treatments had a higher risk of cancer, heart disease, stroke and blood clots.

Estrogen can be valuable as a short-term treatment for women experiencing hot flashes and night sweats, according to the National Institute on Aging. Estrogen replacement therapy, which is approved by the Food and Drug Administration (FDA), comes as a pill, patch, gel, topical spray or vaginal ring. The pellet form is not FDA-approved.

Provided there are no significant risk factors, such as active heart disease, estrogen-dependent cancer or a history of blood clots, we will start at a low dose of bio-identical hormone replacement, Soltes says. After six to eight weeks, the dose may be adjusted.

Certain antidepressants in particular, selective serotonin reuptake inhibitors (SSRIs) prescribed in a low dose can help reduce hot flashes. They act by altering the brain neurotransmitters involved in temperature regulation. Low-dose paroxetine (Brisdelle) is the only FDA-approved SSRI for treatment of hot flashes.

Clonidine, a blood pressure medication, and gabapentin, prescribed for seizures and pain, are also used to relieve hot flashes, although they are used off-label.

If hot flashes are not severe, some women take the herb black cohosh or bee pollen, though research studies have been small and have had mixed results. There has been quite a bit of research on herbal therapies, most of which do not provide more symptomatic relief than a placebo, Soltes says. Black cohosh has been the only herb that seems to have estrogen-like qualities, which may be effective in providing relief for at least six months.

Weekly acupuncture treatments may also be effective, she says. Acupuncture has been shown to reduce the frequency of hot flashes, although it does not work for all women, according to a 2016 study from Wake Forest Baptist Medical Center published in the journal Menopause.

Lifestyle measures include avoiding caffeine, alcohol and spicy foods, adopting stress-reduction techniques and dressing in layers of cotton clothing, Soltes says.

David Walega, MD, associate professor of anesthesiology and pain management at Northwestern Universitys Feinberg School of Medicine, has been researching new treatment options.

His 2013 study of a numbing medicine, injected in the neck, showed promising results on a small sample of women. Half of the women received an injection of bupivacaine hydrochloride a local anesthetic that blocks nerves and can alleviate pain into the stellate ganglion, a nerve bundle in the neck. The other half received a placebo injection.

Women who received the real injection had a 52% decrease in their moderate to severe hot flashes at the six-month follow-up a statistically strong effect, Walega says. Secondarily, we saw trends of improved depression and anxiety scores and also observed improved verbal learning on cognition testing in the treatment group but no improvement in the placebo group, he says. The study showed that benefits of the injection lasted at least six months. In some cases, Walega has seen benefits last as long as 18 months.

Walega and his team are working on a similar study of the numbing injection with a larger group of women. He hopes that the results, expected in about three years, will give women a safe option to effectively treat their debilitating hot flashes.

Barler participated in Walegas study. She had tried hormone pills and hormone patches. The pills didnt work for her, and the patches were expensive, not covered by her insurance and had some cancer risks.

When nothing seemed to help, Walegas numbing injection did. It was a life-changer, Barler says. Although the pilot study has ended, she continues to get the injections and has gone as long as two years between injections.

Barler has changed from constantly being hot to being comfortable. I used to wear shorts and tank tops at home, even in winter, she says. Now I wear long-sleeve sweatshirts, yoga pants and warm socks around the house.

While hot flashes can still be debilitating to many women, the hope is that new research will take the heat off of menopause.

Nancy Maes, who studied and worked in France for 10 years, writes about health, cultural events, food and the healing power of the arts.

Excerpt from:
Hot Flashes Can Be Fast and Furious - Chicago Health

Sunday evening, Ryan T. Anderson and Robert P. George authored: Physical Interventions on the Bodies of Children to Affirm their Gender Identity Violate Sound Medical Ethics and Should be Prohibited. The outlet for this nonsense is Witherspoon Institute's pretentious blog.

I say nonsense because neither author is concerned for the welfare of gender incongruent children. Nor do they voice legitimate concern for medical ethics because ethics are predicated on medical science. Treatment of children should be in accordance with the best available evidence.

Doing so is ethical per se. Neither Anderson nor George care about the medical science. As you will see, it is what they propose that is unethical because it deviates from accepted medical practice.

This entire exercise is a pseudo-scientific effort to support the teachings of the Catholic Church. The term gender identity is within defense quotes because the Church teaches that gender identity doesn't exist. The Vatican has explicitly stated that Church teachings about gender are based on conforming with Genesis 1:27.

The next time that Anderson or George are ill I doubt that they will ask a physician to substitute information from ancient texts of dubious provenance for evidence-based science.

We begin with the verbose subtitle:

Gender identity is formed by the age of two or three. Parents and others treat toddlers with the assumption that their gender and natal sex are consistent. If children are subject to any influence it is cisgender affirmation. We teach children that they are what their genitalia depicts. Gender identity is independent of parental influence. They continue:

In other words, daddy turned his kid into an ATM.

The greater dishonesty is that this case has little to do with the child's medical care. At seven years of age, she will not be a possible candidate for medical interventions for several years. Puberty blockers might be appropriate at age 12 to 13. Whether or not she receives medications will be based upon the persistence of the condition. Persistence is a function of severity.

By the way, the judge who upended a jury verdict in favor of the kid's mother has been recused. Throughout this saga, mom was indifferent to the media knowing that less attention to this case favored the child. Dad, on the other hand, turned this case into a means of support. He was in continuous contact with conservative Christian media. Dad's behavior has been consistent with his history of dishonesty. But I digress.

Getting back to Andergeorge:

I agree with Andergeorge that ethics are an important consideration. Medical ethics are generally defined by the best available information derived from peer-reviewed research published to respected academic journals. That research is based on evidence.

Based upon the evidence-based science, the ethics of treating gender dysphoria in children are expressed by the American Academy of Pediatrics. The AAP's policy statement defines best practices as the gender-affirmative care model.

Deviating from that policy constitutes a breach of ethics. That is particularly true when the deviation is based upon faith over science. The only way that Anderson and George can support Church teachings is to turn a medical condition into an ideology. When either of them can cite peer-reviewed research to support their contention they might have a legitimate argument.

In other words, the following paragraph is, well baloney:

In children, gender dysphoria diagnosis involves at least six of the following and an associated significant distress or impairment in function, lasting at least six months.

Neither Ryan T. Anderson nor Robert P. George have the erudition to assess the science. They do cite some research dishonestly in order to quote:

With approximately one-third of TGD [transgender and gender diverse] adults and 40 percent of TGD youth identifying as nonbinary, care guidelines that reinforce binary systems of gender identity may limit access to clinical services and restrict the ability of nonbinary people to navigate medical systems. Framing gender as solely binary defines therapeutic options and outcomes only in reference to two gender experiences, which impacts access.

They mention the informed consent model. This was developed at the Fenway Institute in Boston, at least in part with the guidance of Dr. Sari Reisner at Harvard Medical School. Fenway Institute has published a brochure regarding the treatment of children. At its core is legal (parental or guardian) consent and this:

Demonstrated long-lasting, non-traditionalgender identity that results in significantdistress or gender dysphoria.

Persistent, documented gender dysphoria(this is part of what you will discuss with yourprovider)

Have another helping of baloney with green mold:

The philosophical problems highlight why this treatment protocol is misguidedindeed, why it violates sound norms of medical ethics. The purpose of medicine is to bring about human health and wholeness, human flourishing in the physical and psychological domains. Here health is understood not as the satisfaction of desires but as the well-functioning of the mind and body, where our various bodily systems achieve their endsthe circulatory system to circulate blood, the digestive system to digest nutrients, the respiratory system to absorb oxygen, etc.and where our thoughts and feelings achieve their ends of bringing us into contact with reality. Thus, any medical intervention intended to affirm someones false beliefs is inherently misguided. Affirming a falsehood via medical technology gets it wrong, right from the start.

Anderson was a music major turned philosopher. George is a lawyer. The care of children (which is at least what their title refers to) should be based on the best available science. Neither of these gentlemen have the training or experience to attack the science. They assert that gender-affirming care represents the satisfaction of desires as if it is gratuitous.

I have news for both of these people. A child in distress does not require a medical intervention to affirm their gender. They are inexorably drawn to do so without the assistance of anyone else.

Anderson's and George's polemic is full of preposterous hyperbole. The do just the opposite with gender dysphoria. They attempt to understate a child's understanding of their gender as some sort of false desire. Tell that to a kid in considerable distress or their parents.

The parents' response to this religious drivel will be one word: Bullshit. Shame on Ryan T. Anderson and Robert P. George for attempting to conform medical science to the teachings of the Catholic Church. They are not only manipulating the best science regarding treatment but they are falsely portraying what medical science knows about people (particularly children) with gender dysphoria.

Anderson and George go on to provide Five Points to Remember. I am going to give each a drivelectomy because Andergeorge are painfully verbose:

First, these procedures are entirely experimental. There is not a single long-term prospective study of the long-term consequences of blocking an otherwise physically healthy child from undergoing normal pubertal development. Indeed, the drugs being used to indefinitely delay normally timed puberty are not FDA-approved for this purpose and are being used off-label.

are these prepubescent children able to provide consent for the treatment? Giordano says that they can, so long as the clinician discusses all potential risks and benefits, as he or she must do with any experimental drug. Because this is the only therapy available for children with GID, it might be considered unethical to deny this treatment option.

It would be unethical to allow a patient to suffer through the distress of pubertal development when we have a way of preventing the distress it causes. Children and adolescents who suffer from gender identity disorder face significant physical, psychological, and social challenges, and receiving an inconsistent standard of medical care adds to those challenges.

[Dr.] Simona Giordano is Senior Lecturer in Bioethics at the School of Law, University of Manchester, UK. She is Programme Director of medical ethics teaching in undergraduate medical education in the School of Medicine, and also teaches for the Master and Postgraduate Diploma in Healthcare Ethics and Law. Simona is a member of the UK Register of Exercise Professionals, and qualified as an exercise instructor in 1999.

Second, parents are told that these procedures are fully reversible, but that is not true. Going off of puberty-blocking drugs, with the hope that development resumes, does nothing to reverse the delayed biologically appropriate development. You cant go back in time and reverse that delay.

Use of GnRH analogues doesn't cause permanent changes in an adolescent's body. Instead, it pauses puberty, providing time to determine if a child's gender identity is long lasting. It also gives children and their families time to think about or plan for the psychological, medical, developmental, social and legal issues ahead. If an adolescent child stops taking GnRH analogues, puberty will resume.

Third, many experts fear that these treatment protocols are self-fulfilling. Telling a little boy that he is a girl (or something else) or a girl that she is a boy (or something else), blocking his or her natural biological development into a man or a woman, and then flooding him or her with opposite-sex hormones will simply reinforce false beliefs.

Fourth, while the diagnosis that someone is of the opposite sex is medically and scientifically baseless, it is particularly outrageous when applied to children.

Fifth, and finally, not only is sex reassignment physically and metaphysically impossible, it doesnt even produce good psychosomatic results. So even if you disagreed with us about the philosophy of the body and the medical ethics of transitioning, you would still need to be concerned that an entirely experimental, self-fulfilling treatment protocol that is based on nonsensical diagnostic criteria doesnt even produce the desired outcomes of happiness and wholeness. Forty-one percent of all adults who identify as transgender attempt suicide at some point in their lives, and adults who have had sex reassignment surgery are nineteen times more likely than the general population to die by suicide.

I believe that the suicide statistics they quote is from a study assessing transgender surgery recipients going back 40 years. Surgery did not reduce minority stress. Anti-trans diatribes from religious lunatics increases minority stress. Nice job boys.

Included in point 5 is this bit of bullshit which I am paying attention to only to demonstrate how thoroughly dishonest these two are:

One more time, the title of this idiocy is: Physical Interventions on the Bodies of Children to Affirm their Gender Identity Violate Sound Medical Ethics and Should be Prohibited. What does any of that have to do with children? WPATH recommends that only adults are candidates for surgery.

I have not addressed two-thirds of this tirade. You can read it in full if you have some brain cells to spare. While they do not cite science to support their views Anderson and George provide numerous links to purchase Anderson's idiotic book on this subject which is nothing but an extension of the catechism.

I expect this kind of gibberish from Ryan T. Anderson. He is an over-educated religious zealot with the critical thinking skills of toilet tissue. I am disappointed in Robert P. George. In 2015 George had a meltdown over the ruling in Obergefell v. Hodges. He went so far as to promote nullification. Since then he mellowed on LGBTQ issues. George even came to the defense of Father James Martin who has questioned Church teachings regarding gay people.

Dr. George has considerable skill. I cannot imagine why he would lend his name and gravitas to something that is so profoundly dishonest.

The audience for this trash are like minded religious conservatives. What happens when one of them has a gender incongruent child? Are they going to risk a child's life to conform to the expectations of George and Anderson who torture medical science to conform to the teachings of the Catholic Church? Hopefully, they will consult with a secular psychiatrist for a proper evaluation.

Related content:

Read the rest here:
Ryan T. Anderson and Robert P. George Have Reached Conclusions About Trans Youth - The Slowly Boiled Frog

Founded in 1999, St. James Infirmary is a nonprofit organization based in San Francisco that provides free and confidential health care for sex workers. Recognizing the need for more compassionate care for sex workers, two associations, Call Off Your Old Tired Ethics (COYOTE) and the Exotic Dancers Alliance (EDA), founded the clinic in collaboration with the San Francisco Department of Public Health STD Control and Prevention Section. Its billed as an Occupational Health and Safety Clinic run by and for Sex Workers, past or present.

According to its website, St. James Infirmary provides upwards of 1,000 health care services to 300 unique patients, a syringe distribution and collection program, as well as education and training workshops that hundreds of sex workers attend, all in addition to basic primary care. The intention behind these classes is to dispense information about sexual health to take a more preventativemeasurewhen it comes public health and safety, rather than a punitive approach that results in jail time.

Named after the prolific sex-positive advocate Margo St. James, she, along with Carol Stuart and Jefferey Klausner, spearheaded activist collaboration, as profiled by a Jezebel interview. The clinic was immediately flooded with patientsdue to its welcoming and nonjudgmental atmosphere.

Speaking to Jezebel, Scarlett Paradise, a transgender woman, was given fundamental shelter and clothing at St. James. She said without the emotional support and sense of community St. James Infirmary offers, she wouldnt have survived.

The clinic is still running strong in San Francisco today, with a reported annual budget of $1 million dollars and moved its location to the Tenderloin District in San Francisco.It is expanding its services to counseling and mental health programs, hormone therapy, as well as partnering with OBGYN student residents from the University of California, San Francisco. St. James welcomes people of all sexual orientations, races, genders and backgrounds.

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The first health care clinic run "by sex workers for sex workers" is 20 years old - The Hill

CHICAGO--(BUSINESS WIRE)--Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced positive topline results from the in-clinic stage of a Phase 2 study of its developmental ready-to-use (RTU) glucagon in patients who experience postprandial hypoglycemic episodes following bariatric surgery.

This is a Phase 2 prospective, randomized, placebo-controlled, double-blind study that comprises an in-clinic stage followed by a 12-week outpatient stage. Subjects are randomly assigned to receive RTU glucagon or placebo during two separate meal challenges in an in-clinic stage crossover design, and then enter a parallel design outpatient stage where they are assigned to an investigational product for 12 weeks. In this study, subjects self-administer a mini dose (300 g) of RTU glucagon or placebo when they experience hypoglycemia symptoms (e.g., anxiety, nausea, sweating, tremors, palpitations), and blood glucose response is measured after the study drug is self-administered. In situations where hypoglycemia (blood glucose 70 mg/dl) is present at mini-dosing or continues after treatment, oral glucose tabs are used in addition to the study drug. The in-clinic stage is now complete, and this study is currently ongoing in the outpatient stage, where both subjects and investigators remain blinded. For more information, visit http://www.clinicaltrials.gov Identifier: NCT03770637

Results from the in-clinic stage of this Phase 2 study demonstrate that most subjects experienced postprandial hypoglycemia within 90-120 minutes after finishing the meal. Of patients with a successful meal challenge, all subjects were also able to self-administer a mini dose of study drug, as directed, during the setting of declining blood glucose. A mini dose of RTU glucagon was adequate to restore or maintain normal blood glucose levels within 15 minutes of administration. This effect was maintained at 30 minutes, and hyperglycemia was not observed. The incidence of a follow-on episode of hypoglycemia (rebound hypoglycemia) requiring oral glucose for rescue was less with RTU glucagon compared to placebo. Treatment emergent adverse events with a mini dose of RTU glucagon were comparable to placebo, including negligible injection site reactions. Mini doses of RTU glucagon appear safe and well tolerated, and no serious adverse events occurred.

We are encouraged by the results of the in-clinic stage of our PBH study. The first half of this study is an important first step in demonstrating the utility of liquid, stable, ready-to-use glucagon in conditions beyond rescue for severe hypoglycemia and demonstrating safety and effectiveness in situations that require self-administration by the patient, said Paul R. Edick, Xeris Chairman and CEO. We believe the second half of the study, which is outside of the controlled in-clinic environment, will go further in establishing the safety profile of mini dosing RTU glucagon. That additional data will be available in the first half of 2020.

About Post-Bariatric Hypoglycemia (PBH)

Approximately 200,000 weight loss (bariatric) surgeries are performed annually in the United States. Hypoglycemia that occurs after bariatric and other forms of upper gastrointestinal surgery is a condition called post-bariatric hypoglycemia (PBH). It usually occurs >6 months to 8 years after surgery and is an uncommon and rarely reported metabolic complication that can be severe and disabling for some patients. Hypoglycemia episodes from PBH occur 1-3 hours after meals (postprandial hypoglycemia), often at a frequency of >10 times per month. Persistent or unrecognized hypoglycemia from PBH can progress to severe hypoglycemia (blood glucose <54 mg/dL) with symptoms such as loss of consciousness, seizures, coma, and even death. When postprandial hypoglycemia episodes in PBH occur, they can be difficult to acutely treat with oral carbohydrates alone, because an overcompensation with oral carbohydrates can frequently trigger a subsequent hypoglycemia episode (rebound hypoglycemia).

About Glucagon

Glucagon is a metabolic hormone secreted by the pancreas that raises blood glucose levels by causing the liver to rapidly convert glycogen (the stored form of glucose) into glucose, which is then released into the bloodstream. Glucagon and insulin are two critical hormones in a glycemic control system that keep blood glucose at the right level in healthy individuals. In people with diabetes who are dependent on insulin, this control system is disrupted, and insulin must be injected to avoid high levels of blood glucose (hyperglycemia). The opposite effect, or low blood glucose (hypoglycemia), is also prevalent in this population due to dysregulated glucagon secretion. Severe hypoglycemia is a serious condition and can lead to seizures, coma, potential brain injury and, if untreated, death.

Glucagon is the standard of care for treating severe hypoglycemia. According to the American Diabetes Association, glucagon should be prescribed for all individuals at increased risk of clinically significant hypoglycemia, defined as blood glucose <54 mg/dL (3.0 mmol/L). Leveraging XeriSol, one of Xeris two proprietary formulation technology platforms, Xeris has the potential to provide the first ready-to-use, room-temperature stable liquid glucagon for use by people with diabetes and other conditions to prevent or manage various forms of hypoglycemia and improve glucose control.

About Xeris Pharmaceuticals, Inc.

Xeris (Nasdaq: XERS) is a specialty pharmaceutical company delivering innovative solutions to simplify the experience of administering important therapies that people rely on every day around the world. With a novel technology platform that enables ready-to-use, room-temperature stable formulations of injectable and infusible therapies, the company is advancing a portfolio of solutions in various therapeutic categories, including its first commercial product, Gvoke. Its proprietary XeriSol and XeriJect formulation technologies have the potential to offer distinct advantages over conventional product formulations, including eliminating the need for reconstitution, enabling long-term, room-temperature stability, significantly reducing injection volume, and eliminating the requirement for intravenous (IV) infusion. With Xeris technology, new product formulations are designed to be easier to use by patients, caregivers, and health practitioners and help reduce costs for payers and the healthcare system.

Xeris is headquartered in Chicago, IL. For more information, visit http://www.xerispharma.com, or follow us on Twitter, LinkedIn or Instagram.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Xeris Pharmaceuticals, Inc., including statements regarding the acceptance of Gvoke in the marketplace, the market and therapeutic potential of its product candidates, expectations regarding clinical data, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing or likelihood of expansion into additional markets, expectations regarding the timing of the commercial launch of Gvoke HypoPen, the potential utility of its formulation platforms and other statements containing the words "will," "would," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, without limitation, the regulatory approval of its product candidates, its ability to market and sell its products, if approved, its reliance on a single source supplier for Gvoke HypoPen and other factors discussed in the "Risk Factors" section of the most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Xeris subsequent filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Xeris expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

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Xeris Pharmaceuticals Announces Positive Topline Results From the In-clinic Stage of the Phase 2 Study of Its Developmental Ready-to-use (RTU)...

Ash Lammin: Not everyone is going to understandSWNS

A 12-year-old who identifies as a girl is about to become one of the youngest children in Britain to take hormone blockers in her bid to change gender.

Ash Lammin, who was born a boy, changed her name from Ashton by deed poll aged eight. Her mother Terri, 43, who has seven other children, said: Although she was born male, from the moment she could speak Ash insisted she was a girl.

Ash, from Ramsgate, Kent, is about to start the transition from male to female at an NHS-run clinic by taking beta blockers that stop puberty.

She will decide whether she wants gender reassignment surgery when she is 18. If not she will come off the blockers and go through puberty a few years

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Ash Lammin, 12, to take hormone blockers | News - The Times

Someone cut you off on the highway and you had to swerve andnarrowly avoided a collision.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy

While out for a morning run, an angry dog jumps out onto your path and starts growling and barking at you.

In the second before you turned on the lights in your empty house,your coat rack looked like it was a person standing right next to you.

All three of these scenarios can trigger your bodys naturalfight or flight response, which is driven from your sympathetic nervous system.This response is your bodys reaction to danger and was designed to help yousurvive stressful and life-threating situations.

The fight or flight response, or stress response, is triggered by a release of hormones either prompting us to stay and fight or run away and flee, explains psychologist Carolyn Fisher, PhD. During the response, all bodily systems are working to keep us alive in what weve perceived as a dangerous situation.

Without you even telling it what to do, your body is assessing whats going on around you and determining your options on how you most likely could survive the event.

Heres what can happen during the stress response:

During the fight or flight response your body is trying to prioritize, so anything it doesnt need for immediate survival is placed on the back burner. This means that digestion, reproductive and growth hormone production and tissue repair are all temporarily halted. Instead, your body is using all its energy on the most crucial priorities and functions.

The stress response can be triggered in a single instant, but how quickly you calm down and return to your natural state is going to vary from person to person (and it will depend on what caused it). Typically it takes 20 to 30 minutes for your body to return to normal and to calm down.

Our fight or flight response was designed to help usthrough catastrophic circumstances, says Dr. Fisher. If you think about itfrom an evolution standpoint, it makes sense because we used to have a lot morelife-threatening emergencies.

Back in the caveman days, danger was all around us andthreats were constant. We didnt know where our next meal was coming from, wehad to brave the weather and we had to fight predators all around us. Arustling bush could be a lion or something else trying to kill you.

And so our ancestors developed the stress response to helpus survive.

Fortunately in todays word, real danger is few and farbetween, but that doesnt mean weve lost our ability to trigger the fight orflight response. It might happen while youre on an airplane thats experiencingturbulence or when someone jumps out at you from a dark room. And itll morethan likely be triggered if youre in a car accident, being robbed orexperiencing something else traumatic.

Where it gets tricky is when your body starts triggering thefight or flight response during non-threating situations like giving a bigpresentation, trying to make a deadline at work or merely thinking about a phobia, such as spiders or heights. Thesesituations arent truly dangerous, but theyve triggered our stress responseand our body is reacting to it as if it was.

In evolution, the stress response was designed to help us survive, but thats not always how it plays out in todays world, says Dr. Fisher. Our fight or flight response can now be activated from psychological or mental stress. For example, some individuals can activate it just thinking about work tomorrow.

Living in a prolonged state of high alert and stress (when there isnt any real reason for it) can be detrimental to your physical and mental health.

Your autonomic nervous system is a delicate balancing actbetween your sympathetic nervous system and your parasympathetic nervoussystem. Both networks involuntarily react to the environment around you.

Your sympathetic nervous system is responsible for how your body reacts to danger and is responsible for the fight or flight response. While your parasympathetic nervous system is responsible for maintaining homeostasis, which is your bodys built-in stability monitor. Think of it like a generator making sure everything from your body temperature to your water intake is functioning smoothly. Your parasympathetic nervous system makes sure things are balanced. It works to relax you and helps conserve and restore energy.

You need both systems to run properly.

Think of your sympathetic nervous system and yourparasympathetic nervous system like your cars gas and breaks, explains Dr.Fisher. You need to use both effectively for your car to run properly.

You need your sympathetic nervous system to keep you alive when true danger is detected and you need your parasympathetic nervous system to restore and relax you so that your body can run business as usual.

So if you find that your body is constantly reacting to every day stress with the fight or flight response it should be a warning sign that your sympathetic and parasympathetic systems arent working together in harmony.

Often times stressors that arent life threating dont havea clear on or off switch, says Dr. Fisher. Thats where we see some of thedetrimental effects of prolonged stress because its not going away. Its achronic stress to our immune system.

Work, bills, kids, your marriage, finances and health are some of the biggest non-life threatening stressors. How you interpret these things can affect your bodys reaction and can contribute to anxiety disorders.

Some people are having the fight or flight response whenthey go to work or see that their kid didnt clean up their room, says Dr.Fisher. It can vary from person to person in terms of the situations that cantrigger the stress response, but were finding that certain conditions orhealth states can be associated with this imbalance.

Some people who get in a car accident are too afraid to drive again or cant drive past the spot where the accident was because of fear and anxiety. It becomes a generalized fear response to a situation that isnt particularly dangerous anymore. This can also happen with work or strained relationships. The next thing you know, your fight or flight response is falsely activated, putting you in a state of chronic stress.

Dr. Fisher says stress management is critical to overallhealth. Its important to think big picture when you feel yourself starting toget worked up over something that you know is not a true threat or danger.

The fight or flight response is an important reaction that we all have and need, but its meant for true stress and danger. Everyone is going to have it in varying degrees for different reasons, but learning to slow down, be aware and conceptualize whats actually happening can help you regain control.

You need to get in touch with your individual physical,emotional and behavioral signs of stress, says Dr. Fisher. Maybe a migrainemeans youve had prolonged stress going on, so you need to tune into your bodyand whats going on before it gets to a crisis point.

If youre at the point where stress is impacting your quality of life talk to your doctor. Therapy, medication and stress management techniques can help you return to a more balanced state. Its not a quick fix and youll have to work on it daily, but you should be proactive about stress.

The fight or flight response has a clear purpose and function, but it shouldnt be activated over every day, non-threatening stressors like traffic, emails or bills. And if it is, the goal is to feel skilled at having an awareness when the response is activated, and to be able to bring yourself back to baseline.

Link:
What Happens to Your Body During the Fight or Flight Response? - Health Essentials from Cleveland Clinic

ONE of Britains youngest transgender children has started transitioning - after realising she was born in the wrong body aged just three.

Ash Lammin, 12, was born Ashton, but insisted that she was a girl as soon as she could speak at home in Ramsgate, Kent.

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Her mum Terri Lammin, 43, said that watching her daughter grow up confused and upset by her body was "heartbreaking".

She said: "Although she was born male, from the moment she could speak Ash insisted she was a girl.

"By age five, she was asking 'when is someone going to chop my winky off?' - and questioning why she had it at all."

Ash says that it has been difficult growing up as a trans girl, but says she feels that she is firmly on the right path.

She said: "The journey is long and it's still going, but I feel like the sense of victory is there through it all.

"I do feel accepted sometimes, but other times not.

"Not everyone is going to understand and people have to have their own opinions and I understand that. Some people might not like the idea of trans.

"I hope I inspire others but I just hope that love and acceptance comes through everything."

Now, aged almost 13, she is embarking on a lengthy journey to transition her gender from male to female at an NHS-run clinic - and is one of the youngest in the country to do so.

Ash - who changed her name by deed poll to Ashley when she was eight - will start by taking hormone blockers to halt the onset of puberty.

I do feel accepted sometimes, but other times not.

She has researched the process incessantly - and eventually wants a womb transplant so that she can be a mother when she's older.

Terri added: "I never thought it was a phase, Ash was just Ash.

"When she was three she said to me, 'I'm a boy because you gave me a boy's name - it's your fault.'

"I remember feeling horrible, because she blamed me. I personally thought maybe this was what an extremely camp gay man is like as a child."I'd never come across it before and I just went along with it. I just thought 'if he's happy, well that's the main thing.'"

But Terri, who has seven other children, said that life became much harder when Ash started at primary school.

She said: "I sent her to school in a boy's uniform. I felt awful, she didn't want to wear it and I was making her.

"The school were great. The headmaster at the time said 'if you think it's going to make life easier then bring Ash in a girl's uniform', so I did.

"I was in a right state. I thought 'everybody is going to think I'm weird' - but Ash loved it, she found it easy.

"Before, when I was taking her into school, she was biting me and kicking me, she didn't want to go in.

Although she was born male, from the moment she could speak Ash insisted she was a girl

"As soon as she put the girl's uniform on, she wanted to go every day."

Despite the school's willingness to help and the kindness of Ash's classmates, Terri says that other parents were very difficult - leaving her out of social events and complaining that Ash was using the girls' toilets.

She added: "When Ash was Ashton, she was invited to all the kids' parties, even though she used to turn up in a princess dress.

"The parents didn't mind then. But as soon as I let her be Ashley all the time, for a whole year she didn't get invited to one party.

"The kids were fine; it's not the children, kids play with anybody. It's not until an adult comes in and says you shouldn't do that then it changes."

When Ash turned 11 and went to secondary school, she became a target for bullies who would throw things at her on the bus and shout tranny at her.

Her mum was forced Terri to take her out of the school after just one term.

She is now being home-schooled, and Terri is calling for better education within schools to teach children about transgender people.

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One of Britains youngest transgender kids, 12, transitions after realising she was in wrong body aged 3 - The Sun