Category Archives: Molecular Medicine

This week, two high-profile, late-stage clinical trials Johnson & Johnsons test of a coronavirus vaccine and Eli Lillys study of a COVID-19 drug were put on pause because of possible safety concerns. Just a month earlier, AstraZenecas vaccine trial was paused after two volunteers became seriously ill.

Clinical trials experts said these delays were comforting, in a way: They show that the researchers were following proper safety procedures. But for now, details about the nature of the volunteers illnesses are scant. And although pauses of vaccine trials are not unusual, some experts said that pausing treatment trials like that of Eli Lillys antibody drug is rarer and perhaps more worrisome.

That trial was testing the treatment on hospitalized patients a group that was already sick and in which declines in health would not be surprising. So for a trial like that one to be paused, the safety concerns must have been significant, they said.

For now, the companies behind the trials arent saying much. In a statement in September, AstraZeneca said it paused its trial to investigate a single event of an unexplained illness. But two vaccinated volunteers reportedly developed the same condition, an inflammation of the spinal cord called transverse myelitis.

Johnson & Johnson said that it was pausing its vaccine trial because of an unexplained illness. Eli Lillys trial of the antibody treatment was paused because of a so far undisclosed health difference between the group that received the drug and the group that received a placebo.

When people volunteer for a late-stage trial, known as phase three, they randomly get a treatment or a placebo, and neither they nor their doctor knows which one they received. In the weeks that follow, theyre carefully monitored. People in a vaccine trial may get a checkup each month and record any symptoms they experience in a journal. People who get a drug while theyre hospitalized may be given blood tests and medical exams.

Mild symptoms, like a minor rash or a headache, arent enough to pause a trial. But when investigators notice a serious problem known as an adverse event they have to report it to the sponsoring companies. And the sponsors then have to report to both the Food and Drug Administration and their independent advisers, known as data and safety monitoring boards.

If the board or the company judges the adverse event to be particularly concerning, they may put the trial on pause even without yet knowing if the event happened to someone who got the treatment or the placebo.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDAs vaccine advisory panel, said that pausing a trial is a huge logistical challenge especially for one like Johnson & Johnsons, with plans for 60,000 volunteers in 10 countries.

Its this big warship that you just stop moving, Offit said.

Once a trial is paused, a safety board may ask for a volunteer who experienced an adverse event to be unblinded in other words, to find out if the volunteer got the placebo or the treatment. If the volunteer received a placebo, then the treatment cant be the cause of the event, and the trial can continue.

If it turns out that the volunteer got the treatment, the board does a flurry of detective work. The members look over the medical records. They may ask for more information about volunteers health or even order new tests not just for the people who experienced adverse events, but for everyone in the trial.

The board uses this evidence to come to a conclusion about whether the treatment most likely had anything to do with the event. On very rare occasions, for example, some vaccines can cause a nerve disorder called Guillain-Barr syndrome. But the condition takes weeks to develop. If a volunteer shows signs of Guillain-Barr syndrome on the day of a vaccine injection, it cant be the cause.

Regulators then review the decision of these boards and may accept it or ask for more information. For trials that are running in several countries at once, this review can make pausing a trial even more of a challenge. After AstraZeneca paused its global trials Sept. 6 for a review, regulators in Brazil, India, Japan, South Africa and the United Kingdom all gave the green light for the trial to resume. But American regulators are still keeping the U.S. trial on pause as they continue to look over the evidence.

If a safety board rules that an adverse event most likely was not a result of the vaccine or treatment, it may allow the trial to start up again. If, on the other hand, theres some urgent problem a contaminated batch of drugs, for example the trial may have to stop. When the evidence isnt so clear, the board may let the trial resume with extra tests or exams. A second case of the same event might be more common than you would expect from chance, forcing the trial to end.

But there are some important differences in the way pauses work in trials for vaccines like Johnson & Johnson and AstraZenecas and for drugs like Eli Lillys. Vaccines are designed to be given to millions or billions of healthy people, so they require extreme safety. If even one person in a vaccine trial gets sick, that warrants a closer look.

It is not at all uncommon for this to happen, said Dr. Anna Durbin, a professor of international health at the Johns Hopkins Bloomberg School of Public Health. In the vast majority of cases, the trial continues.

And in a trial as big as Johnson & Johnsons, you expect some sort of adverse event to happen, regardless of the potential risks of the treatment being tested. It would be strange if investigators reported nothing. Then youre concerned that the surveillance system for adverse events isnt working, said Saad Omer, director of the Yale Institute for Global Health.

Dr. Stanley Plotkin, a vaccine expert and professor emeritus at the University of Pennsylvania, was not surprised that two vaccine trials were paused. After all, a huge number of vaccine candidates 43 to date are being tested in clinical trials. Many of them are based on cutting-edge designs that have never been licensed before. It means a lot of new ground is being broken, he said, so people are being doubly careful.

But pauses of treatment trials are not as common. Theres a simple reason for the difference: The people getting drugs have a disease, sometimes a very serious one. For Eli Lillys trial, for example, researchers are only recruiting people who are already hospitalized with COVID-19. In such a group of seriously ill people, even a death would, sadly, not come as a great shock.

As a result, the evidence for an adverse event often has to reach a higher bar to pause a drug trial. Indeed, that seems to be the case with the paused COVID-19 trials. One patient was enough to cause Johnson & Johnson to halt its trial. But a National Institutes of Health spokesperson said the Eli Lilly trial was paused because the safety board found that the patients who had received the antibodies showed a different clinical status than those who had received a placebo.

Dr. Eric Topol, a professor of molecular medicine at Scripps Research in La Jolla, California, is still hopeful about the antibody treatment. He observed that both Eli Lilly and another company, Regeneron, have already given monoclonal antibodies to thousands of people with COVID-19 without any previous reports of problems (although some of the trials were on people with relatively mild cases). Im still fairly optimistic, he said.

Although pausing trials is a standard procedure, its not a familiar one. Before the pandemic focused the worlds attention on clinical trials, researchers would pause trials and investigate adverse events without much notice. If a paused trial has to be abandoned, that pause might get mentioned a year later in a scientific paper about the trial.

But if a trial resumes and ends successfully, then the pause may just seem like an irrelevant detail. You may very well never mention that, said Peter Lurie, president of the Center for Science in the Public Interest and former associate commissioner for public health strategy and analysis at the FDA.

But in a pandemic especially one in which the president of the United States claims without justification that a vaccine will be ready by Election Day and that monoclonal antibodies are a miraculous cure for COVID-19 these pauses are drawing attention like never before. That is something we are not used to at all, Friede said.

Nevertheless, Friede said, it is vital that researchers stick to their protocols, no matter the pressure they feel to speed things up. Thats a very difficult situation to be in, but I think its very important that we keep up the standards, he said.

No matter what the outcome of the pauses, many experts found the caution heartening. It shows me that people are taking safety very seriously, Durbin said. This is an example of how things are supposed to work.

Read this article:
3 COVID-19 trials have been paused for safety. Thats a good thing - Bangalore Mirror

[A new study suggests] that improving vitamin D status in the general population, and in particular in patients hospitalized with COVID-19, could help to reduce the severity of COVID-19 disease and associated deaths. The study, reported inPLOS ONE, found that hospitalized COVID-19 patients who had sufficient vitamin Di.e., they had blood levels of 25-hydroxyvitamin D of at least 30 ng/mLhad a significantly lower risk of adverse clinical outcomes, including becoming unconscious, hypoxia, and death, than patients who were vitamin D deficient.

In addition, patients who were vitamin D sufficient had lower blood levels of the inflammatory marker C-reactive protein, and higher blood lymphocyte levels. This study provides direct evidence that vitamin D sufficiency can reduce the complications, including the cytokine storm (release of too many proteins into the blood too quickly) and ultimately death from COVID-19, commented Michael F. Holick, PhD, MD, professor of medicine, physiology and biophysics and molecular medicine at Boston University School of Medicine.

Vitamin D interaction with its receptor in immune cells modulates the innate and acquired immune systems in response to invasion of bacterial and viral pathogens. Vitamin D also modulates the renin-angiotensin pathway and downregulates ACE2. Therefore, vitamin D might help in treatment of COVID-19 by preventing the cytokine storm and subsequent ARDS [acute respiratory distress syndrome] which is commonly the cause of mortality, the authors commented.

Read the original post

Excerpt from:
Vitamin D shown to reduce severe symptoms of COVID - Genetic Literacy Project

"We're delighted to collaborate with Taisho pharmaceutical, a well-recognized leader in the pharmaceutical industry and healthcare sector. It is believed that aging is a universal phenomenon that we cannot stop. However, emerging scientific evidence has shown that one may be able to reverse some of the age-associated processes. Through this collaboration, we will adopt our AI-powered drug discovery suites together with Taisho's validation platform to explore the new space of anti-aging solutions," said Jimmy Yen-Chu Lin, PhD, CEO of Insilico Medicine Taiwan, a fully-owned subsidiary of Insilico Medicine

Under the terms of the agreement, Insilico Medicine will receive an upfront payment and milestone payments upon achievement of specified goals. Insilico Medicine will be responsible for early research phase target identification and molecular generation and Taisho will work collaboratively with Insilico in validating the results in various in vitro and in vivo assays. Taisho has the exclusive option to acquire Insilico's co-ownership of the successfully developed programs under agreed payment.

"It is our great honor to be collaborating with the scientists of Taisho Pharmaceutical, one of the top 100 pharmaceutical companies in the world operating since 1912. The high level of the scientists we are interfacing, and our previous successes in the application of the Pharma.AI platform for discovery of novel targets and molecules in fibrosis, and previous experience in senolytic drug discovery give us confidence that this collaboration will be successful," said Alex Zhavoronkov, PhD, founder and CEO of Insilico Medicine.

About Taisho Pharmaceutical Co., Ltd.

https://www.taisho.co.jp/global/

Media Contact

For further information, images or interviews, please contact:

[emailprotected]

About Insilico Medicine

Since 2014 Insilico Medicine is focusing on generative models, reinforcement learning (RL), and other modern machine learning techniques for the generation of new molecular structures with the specified parameters, generation of synthetic biological data, target identification, and prediction of clinical trials outcomes. Recently, Insilico Medicine secured $37 million in series B funding. Since its inception, Insilico Medicine raised over $52 million, published over 100 peer-reviewed papers, applied for over 25 patents, and received multiple industry awards. Website http://insilico.com/

Photo - https://mma.prnewswire.com/media/1312850/Insilico_Taisho.jpg

http://insilico.com

SOURCE Insilico Medicine Hong Kong Limited

Link:
Insilico partners with Taisho on end-to-end AI-powered senolytic drug discovery - PR Newswire India

GAITHERSBURG, Md., Oct. 15, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc.. (Nasdaq: OPGN, OpGen), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that total preliminary unaudited revenue for the third quarter of 2020 was approximately $1.0 million, up from $648 thousand in the third quarter of 2019. The preliminary financial results for the three months ended September 30, 2020 reflect the consummation of our business combination with Curetis GmbH on April 1, 2020. The results for the nine months ended September 30, 2020 will be included in the Companys Quarterly Report on Form 10-Q and earnings release for the third quarter of 2020. OpGens cash as of September 30, 2020 was approximately $10.4 million. The company also expanded its capacity under its ATM program by an additional $6.4 million, and continues to have access to an additional EUR5.0 million tranche of non-dilutive debt financing for COVID-19 related R&D programs from the European Investment Bank.

In addition, the company announced details regarding a strategic reprioritization of its product portfolio, platform pipeline and priorities going forward. This reprioritization was based on feedback from extensive market research, a customer survey of 150 stakeholders in the decision making on new diagnostic platforms, and key opinion leader interviews conducted by an independent market research firm over the past two quarters. Following a review of this research, OpGen and its Board decided to consolidate the companys product portfolio on its proprietary Unyvero platform and unique bioinformatics capabilities. As a result of this change in priority, the company anticipates the following key impacts:

The company also announced accomplishment of the following key milestones in the third quarter of 2020 and year to date:

Oliver Schacht, President & CEO of OpGen commented, OpGen reported a solid third quarter given the persistent challenging environment caused by the COVID-19 pandemic. In addition to announcing the CE mark certification for our SARS-CoV-2 Kit, we also highlighted the publication of several peer-reviewed studies. We believe that following the portfolio consolidation and strategic product pipeline decisions taken by the board, OpGen along with its subsidiary companies Curetis GmbH and Ares Genetics GmbH has a focused molecular diagnostics platform strategy and growing emphasis on bioinformatics offerings that will further generate shareholder value. I am truly excited about the future prospect of this company and I am convinced that our strategic initiatives will provide strong growth opportunities and secure our future as a global leader in infectious diseases and AMR diagnostics.

The preliminary financial results are estimates prior to the completion of OpGensfinancial closing procedures and review procedures by its external auditors and therefore may be subject to adjustment when the actual results are available.

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGens product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

For more information, please visit http://www.opgen.com.

Forward-Looking Statements

This press release includes statements regarding OpGens third quarter 2020 results, the companys strategic portfolio and product pipeline priorities, the ongoing integration of OpGen with its acquired subsidiaries, Curetis GmbH and Ares Genetics GmbH, and the impact of COVID-19 on the company and general market conditions. These statements and other statements regarding OpGens future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Companys operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:Oliver SchachtPresident and CEOInvestorRelations@opgen.com

OpGen Press Contact:Matthew BretziusFischTank Marketing and PRmatt@fischtankpr.com

OpGen Investor Contact:Megan PaulEdison Groupmpaul@edisongroup.com

Read the original post:
OpGen Provides Business and Pipeline Update and Announces Preliminary Unaudited Revenue and Cash Position for the Third Quarter 2020 - BioSpace

Two Americans and one British-born scientist now working in Canada have won the 2020 Nobel Prize in medicine or physiology on Monday for their discovery of the hepatitis C virus.

Thomas Perlmann, secretary of the Nobel Committee and professor of molecular development biology at the Karolinska Institute, announced the award at a ceremony in Stockholm.

Harvey Alter of the National Institutes of Health in Bethesda, Md., Michael Houghton the University of Alberta in Canada, and Charles Rice of Rockefeller University in New York City share the prize.

advertisement

Their work has helped speed the fight against blood-borne hepatitis, a major global health problem that causes cirrhosis and liver cancer in people around the world. Their discovery has also allowed for the rapid development of antiviral drugs directed at hepatitis C.

The discovery of hepatitis C virus was important for public health in two ways, biochemist Jeremy Berg, professor of computational and systems biology at the University at Pittsburgh and former director of the NIHs National Institute of General Medical Sciences, told STAT. First, the discovery enabled testing for screening blood for the agent that was responsible for blood-borne transmission of hepatitis and liver cancer risk. Second, knowledge of the causative agent facilitated drug development, particularly protease inhibitors that can treat existing hepatitis C virus infections and cure the disease in many cases.

advertisement

Thanks to their discovery, highly sensitive blood tests for the virus are now available and these have essentially eliminated post-transfusion hepatitis in many parts of the world, greatly improving global health, the Nobel Prize committee said in its announcement. For the first time in history, the disease can now be cured, raising hopes of eradicating Hepatitis C virus from the world population.

The three laureates will share 10million Swedish kronor, or about $1.07 million. Their names are added to a list of medicine Nobel winners that includes 222 men and 12 women.

Hepatitis, defined as liver inflammation, is usually caused by a viral infection, although alcohol misuse, environmental toxins, and autoimmune disease can also lead to the same condition. Hepatitis A comes from contaminated food or polluted water, but the illness it causes is relatively brief in duration. Hepatitis C, like hepatitis B, is a blood-borne infection, bringing acute illness to some people but chronic disease to 71 million people around the world, according to WHO estimates.

This is the second Nobel Prize awarded for a hepatitis discovery. In the 1960s, Baruch Blumberg, who identified what became known as the blood-borne hepatitis B virus, won the prize in 1976. Baruch laid the groundwork for the development of diagnostic tests and an effective vaccine.

Alter had also been studying hepatitis in patients who had received blood transfusions. Tests based on Baruchs work could diagnose transfusion-related hepatitis B, but they still couldnt explain a large number of cases. Tests for hepatitis A virus infection were also developed around this time, but could not account for these cases. Alter and his NIH colleagues proved that this was something different when they showed that blood from these hepatitis patients could transmit the disease to chimpanzees, the only susceptible host besides humans. Later studies determined that this infectious agent was indeed a virus and the disease was a new, distinct form of chronic viral hepatitis that became known as non-A, non-B hepatitis.

Michael Houghton, then working for the pharmaceutical firm Chiron, took the next steps to isolate the genetic sequence of the virus. That meant collecting DNA fragments from nucleic acids found in the blood of an infected chimpanzee, on the theory that they would contain some genetic material from the unknown virus. Houghton and his team used sera from hepatitis patients to identify the virus based on their suspicion that the patients blood would contain antibodies to the virus.

They did find one clone and later showed that it was derived from a novel RNA virus belonging to the flavivirus family and it was named hepatitis C virus. The antibodies in chronic hepatitis patients were the smoking gun pointing toward this virus as the missing agent.

Rice, while a researcher at Washington University in St. Louis, then worked to answer an essential question: Could this clone alone cause hepatitis C? Rice and other groups had zeroed in on one end of the cloned viral genome that hadnt been characterized. There were some variations that made it difficult for the virus to replicate, so he genetically engineered an RNA variant of hepatitis C virus that included the newly defined region of the viral genome and subtracted the inactivating genetic variations. When this RNA was injected into the liver of chimpanzees, virus was detected in the blood, as were the kind of pathological changes seen in humans with the chronic disease. This was the final proof that hepatitis C virus alone could cause the unexplained cases of transfusion-mediated hepatitis.

Rice was previously honored for his studies of hepatitis C replication with the 2016 Lasker Award, often called a precursor to the Nobel. He shared that prize with Ralf Bartenschlager of the University of Heidelberg and Michael Sofia, formerly at Pharmasset and now at Arbutus Biopharma.

And Alter and Houghton shared an earlier Lasker Award, in 2000, for their hepatitis C work, furthering the Laskers reputation as a Nobel predictor. The prize recognized Alters work identifying non-A, non-B hepatitis and Houghtons use of then-early molecular biology methods to isolate the virus.

In 2013, Houghton turned down $100,000 in prize money from the Gairdner Foundation for a prize recognizing the same work because it did not include two colleagues: Qui-Lim Choo and George Kuo, who worked with him at Chiron when they identified and cloned the hepatitis C virus.

I agonized over it, Houghton told The Globe and Mail of accepting another prize in which his colleagues were not named. And I decided I didnt want to do that again.

The three of us worked closely together for almost seven years to discover this very elusive and challenging virus using a novel approach in the field of infectious disease, he told the Canadian Press at the time of the Gairdner prize. The Canadian award is also considered a Nobel bellwether.

In a conference call with reporters Monday morning, Houghton said he would accept the Nobel Prize and his share of the money. It would be really too presumptuous of me to turn down a Nobel, he said, citing the Nobels traditions and regulations drawn from the will of its creator, Alfred Nobel. Most big inventions, not all of them, but most involve many people, and I worked for six or seven years with two colleagues at Chiron Corp. in California, and without their input I doubt I would have succeeded.

This story has been updated with detail on the laureates research.

Sharon Begley contributed to this report.

Read the original:
Trio wins Nobel Prize in medicine for discovery of hepatitis C virus - STAT

SILVER SPRING, Md., Oct. 5, 2020 /PRNewswire/ --The American College Health Association (ACHA) and Scripps Research Translational Institute have announced a partnership to bring the National Institutes of Health (NIH) All of Us Research Program to five campuses this academic year in a pilot program.

All of Us is building the largest, most diverse health resource of its kind by asking one million or more participants to share their health information. Data from such a large and diverse group of people will enable scientists to see patterns in how different factorsfrom genetics to lifestyle habitsimpact a person's health, why some people respond differently to the same condition or treatment, and ultimately how to treat each person based on their unique health story.

Scripps Research is heading up key aspects of the initiative that make it possible for anyone anywhere to participate in research, including integrating mobile health technologies such as wearable devices into the research program, and digital enrollment and engagement of volunteers.

"All of Us represents a far-reaching initiative for what's possible in medical research today and in the futurehow each individual can generate useful data about their own health and what makes them tick," says Eric Topol, MD, Founder and Director of Scripps Research Translational Institute, Professor of Molecular Medicine and Executive Vice-President of Scripps Research. "The initiative will provide an unprecedented window into individual differences in biology, physiology, lifestyle, and environment that shape human health and ultimately will enable us to more effectively prevent and treat illness."

The partnership with ACHA will bring awareness about the program to young, diverse students who are eager to address health inequities on and off campus.

"Many students are seeing health inequities play out in real time as their families have been greatly impacted by COVID-19. Participation in the All of Us program is its own form of health activism, and we think students are ready to take on that challenge," says Devin Jopp, EdD, ACHA's CEO.

The five participating schools include Albion College, California State Polytechnic University-Pomona, Florida International University, Texas Southern University, and University of Louisville. These schools will enlist the help of student engagement associates to bring awareness and education to other students.

For more information on the All of Us Research Program, visit JoinAllofUs.org/students.

About ACHA

The American College Health Association (www.acha.org) is a national nonprofit association and the nation's principal leadership organization for advancing the health of college students and campus communities through advocacy, education, and research. ACHA's diverse membership provides and supports the delivery of healthcare, prevention, and wellness services for the nation's 20 million college students. ACHA advocates for integrating the critical role of college health into the mission of higher education.

About the Scripps Research Translational Institute

The Scripps Research Translational Institute, formerly named Scripps Translational Science Institute, was founded in 2007 with one essential aimto individualize healthcare by leveraging the remarkable progress being made in human genomics and combining it with the power of wireless digital technologies. Bringing together basic scientists and clinical investigators, the Translational Institute fosters highly collaborative multidisciplinary research with the greatest potential to transform the practice of healthcare and improve human health.

About the All of Us Research Program

The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. The program will partner with one million or more people across the U.S. to build the most diverse biomedical data resource of its kind, to help researchers gain better insights into the biological, environmental, and behavioral factors that influence health. For more information, visit http://www.JoinAllofUs.org/students.

Media Contact

Rachel Mack

443-270-4560

[emailprotected]

SOURCE American College Health Association

Originally posted here:
American College Health Association and Scripps Research Translational Institute Partner to Bring the NIH All of Us Research Program to College...

WINNIPEG, AB, Oct. 5, 2020 /PRNewswire/ -Medicure Inc.("Medicure" or the "Company") (TSXV: MPH) (OTC: MCUJF), a pharmaceutical company, announces that through its wholly-owned subsidiary, Medicure International Inc., it has entered into a License, Manufacture and Supply Agreement (the "Agreement") with Reliance Life Sciences Private Limited ("RLS") for a cardiovascular biosimilar (the "Product"). Medicure is responsible for the regulatory approval process for the Product. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an approved reference product. The Agreement grants an exclusive right to Medicure to market and sell the Product in the United States of America, Canada and the European Union.

"We are very pleased with the agreement we have reached with RLS. The Product fits well with Medicure's mission of being a significant cardiovascular company focused on the U.S. market." commented Dr. Albert Friesen, Chief Executive Officer for Medicure. "We look forward to the growth of our portfolio of cardiovascular products."

About Medicure Inc. Medicure is a pharmaceutical company focused on the development and commercialization of therapies for the U.S. cardiovascular market. The present focus of the Company is the marketing and distribution of AGGRASTAT(tirofiban hydrochloride) injection and ZYPITAMAGTM (pitavastatin) tablets in the United States, where they are sold through the Company's U.S. subsidiary, Medicure Pharma Inc. For more information on Medicure please visit http://www.medicure.com. For additional information about ZYPITAMAGTM, refer to the full Prescribing Information.

About Reliance Life Sciences Private Limited Reliance Life Sciences Private Limited (RLS) is part of the Promoter Group of Reliance Industries Limited. RLS is a research driven organization developing business opportunities in bio-therapeutics (plasma proteins, biosimilars and novel proteins), pharmaceuticals, regenerative medicine, clinical research services, and molecular medicine. The Reliance Group isIndia'slargest private sector enterprise, with annual revenues of$ 86 billion USD. The Group's flagship company, Reliance Industries Limited isIndia'slargest private sector company and a Fortune Global 100 company. RLS is a fully integrated life sciences industry player with in-house capabilities in research, pre-clinical and clinical development, process development, quality management, commercial-scale manufacturing, and marketing. For further information on Reliance Life Sciences please visithttp://www.rellife.com/

To be added to Medicure's e-mail list, please visit: http://medicure.mediaroom.com/alerts

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward Looking Information: Statements contained in this press release that are not statements of historical fact, including, without limitation, statements containing the words "believes", "may", "plans", "will", "estimates", "continues", "anticipates", "intends", "expects" and similar expressions, may constitute "forward-looking information" within the meaning of applicable Canadian and U.S. federal securities laws (such forward-looking information and forward-looking statements are hereinafter collectively referred to as "forward-looking statements"). Forward-looking statements, include estimates, analysis and opinions of management of the Company made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors which the Company believes to be relevant and reasonable in the circumstances. Inherent in forward-looking statements are known and unknown risks, uncertainties and other factors beyond the Company's ability to predict or control that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements, and as such, readers are cautioned not to place undue reliance on forward-looking statements. Such risk factors include, among others, the Company's future product revenues, the ability of AGGRASTATto provide benefits to COVID-19 patients, expected future growth in revenues, stage of development, additional capital requirements, risks associated with the completion and timing of clinical trials and obtaining regulatory approval to market the Company's products, the ability to protect its intellectual property, dependence upon collaborative partners, changes in government regulation or regulatory approval processes, and rapid technological change in the industry. Such statements are based on a number of assumptions which may prove to be incorrect, including, but not limited to, assumptions about: general business and economic conditions; the impact of changes in Canadian-US dollar and other foreign exchange rates on the Company's revenues, costs and results; the timing of the receipt of regulatory and governmental approvals for the Company's research and development projects; the availability of financing for the Company's commercial operations and/or research and development projects, or the availability of financing on reasonable terms; results of current and future clinical trials; the uncertainties associated with the acceptance and demand for new products and market competition. The foregoing list of important factors and assumptions is not exhaustive. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements or the foregoing list of factors, other than as may be required by applicable legislation. Additional discussion regarding the risks and uncertainties relating to the Company and its business can be found in the Company's other filings with the applicable Canadian securities regulatory authorities or the US Securities and Exchange Commission, and in the "Risk Factors" section of its Form 20F for the year ended December 31, 2019.

View original content:http://www.prnewswire.com/news-releases/medicure-announces-an-agreement-with-reliance-life-sciences-for-the-marketing-rights-of-a-cardiovascular-biosimilar-301145432.html

SOURCE Medicure Inc.

Read more from the original source:
Medicure announces an agreement with Reliance Life Sciences for the marketing rights of a cardiovascular biosimilar - BioSpace

A group you've probably never heard of holds powerful sway over which coronavirus vaccines will end up on the market.

It's known as the DSMB.

Members of a Data and Safety Monitoring Board are the only ones who get to look under the hood while a trial is ongoing. They know who has been given a Covid-19 vaccine, and who has gotten a placebo. The very doctors running the trials, the pharmaceutical companies that developed the vaccines, and even the US Food and Drug Administration don't know.

Armed with that secret, only the DSMB can monitor how safe and effective a vaccine is shaping up to be.

One word from the DSMB, and a trial can be stopped. That's what happened to the AstraZeneca trial in early September after a study participant developed neurological symptoms. Shortly after, it came to light that the same trial had been paused briefly in July for similar reasons. While the vaccine trial resumed in the UK, it is still on pause in the US.

"They're very powerful. They're key guardians of science and safety and are as important if not more important than the FDA," said bioethicist Art Caplan.

Earlier this year, the National Institutes of Health appointed a common DSMB to monitor Covid-19 vaccine clinical trials that are being funded by the federal government under Operation Warp Speed. This DSMB has 10 to 15 members with specialties including vaccine development, statistics and ethics.

It's not a glamorous or public-facing job. They're paid only a modest honorarium by the NIH -- just $200 per meeting -- and there are no press conferences, no TV interviews, no fame and no glory.

That's because members' names aren't typically revealed while trials are in progress to shield them from external pressures.

Caplan, who has served on about 20 DSMBs, said there's a good reason members' names are kept secret.

"You wouldn't want some investor calling a DSMB member and saying 'Hey, how's this clinical trial looking? If you tell me, I'll give you 10% of whatever I make,'" said Caplan.

Carrie Wolinetz, associate director for science policy at the National Institutes of Health, said various types of people might try to influence DSMB members.

"It doesn't have to be nefarious. Parents of a very ill child might be anxious about how the trial of a drug that could help their child is going, and they might contact the folks at the DSMB. Keeping their names private is a way to preserve independence of the group," she said.

There's a lot at stake. They scrutinize the data carefully. One word from them, and a vaccine's chances of coming to market could be squashed. Millions of dollars spent on research and development could all be for naught.

While there are good arguments for secrecy, Caplan said he disagrees with the confidentiality that currently shrouds the DSMBs for Covid-19 vaccine candidates.

"We need to know if we can trust the vaccine, so the more transparency the better," Caplan said.

In order to reach population immunity through a vaccine, a large proportion of the US public needs to get vaccinated. But confidence in a potential vaccine is low -- 49% of Americans say they definitely or probably would not get a vaccine if one were available now, according to a recent poll by the Pew Research Center.

"We want to know they're fully independent, that they have no prior relationships with the company. So they're not conflicted in any way," said Dr. Eric Topol, professor of molecular medicine at Scripps Research. "We want to know about their expertise. It's important to know who they are."

The job of the DSMB, as the name suggests, is to monitor the data that comes out of clinical trials.

In clinical trials, there can be thousands, or tens of thousands, of study participants. Some are randomly assigned to receive an intervention -- in this case, the vaccine -- and some receive a placebo.

The studies are what's called "double-blinded." The participants don't know which they're getting, and neither do the doctors running the trials.

If a study volunteer has what appears to be a side effect or "adverse event," the DSMB can look and see if they received the vaccine or the placebo.

"If it was a placebo, then it's one of these random things," Susan Ellenberg, a member of Covid-19-related DSMBs, told CNN's Chief Medical Correspondent Dr. Sanjay Gupta. "If it was the vaccine, it could still have been a random thing. But then people have to wring their hands and try and consider how likely is it that the vaccine could cause this kind of event?"

If these events are concerning enough, the DSMB can recommend that the trial be stopped for safety reasons. The stakes are especially high in Covid-19 vaccine trials, which may ultimately be administered to millions of healthy people -- unlike drug trials intended for those who are already sick and may have few options.

"Even an adverse event that happens as infrequently as one in 10,000 people or one in 20,000 people -- that would be a lot of people who would have a serious adverse event," explained Ellenberg, a professor of biostatistics at the Perelman School of Medicine at the University of Pennsylvania.

At pre-determined intervals, the DSMB also checks on efficacy. If people receiving the vaccine get sick roughly as often as those who get the placebo, that's not a good sign. The board can recommend that the trial be stopped due to "futility."

They may also look at the quality of the data, Ellenberg said. If there's missing data, participants who drop out, or if the trial is being conducted poorly, it's the DSMB that can weigh in.

"Most of the time, a data monitoring committee will say, 'Everything looks fine, keep going,' " Ellenberg said. "But sometimes -- you never know when ... a hard decision is going to have to be made. And that's the value of these committees."

Conversely, if it looks like the vaccine is working exceptionally well, the DSMB may recommend that the study sponsor submit an application to the FDA before the official end of the trial, in order to get it more quickly to market.

"The people who serve on these committees are thoroughly vetted for conflicts of interest," Ellenberg said.

Members are screened to make sure they don't have a financial interest in the pharmaceutical company that's sponsoring the vaccine trial.

"DSMB members or their family members should have no professional, proprietary, or financial relationship with the sponsoring companies," according to a statement from the National Institute of Allergy and Infectious Diseases, which organized the common DSMB for the Covid-19 vaccine candidates under Operation Warp Speed -- including Moderna, AstraZeneca and Johnson & Johnson. "Selected DSMB members and their family members were not allowed to work for other companies developing COVID-19 vaccines."

Topol, of Scripps Research, said it's "unprecedented to have a DSMB with that much authority." Typically, each clinical trial has its own DSMB.

Such is the case with Pfizer, whose trial is not neither under the common DSMB nor funded by the government. Pfizer's DSMB comprises "a chairperson and 4 additional members that meets on a weekly basis," according to a spokeswoman.

Topol considers that small for a trial that aims to enroll up to 44,000 participants. "The trials that I ran always had six or seven at least, sometimes eight or nine," he said. "In large trials, you got to have a bioethicist, virologist, an immunologist, epidemiologist... You have all the critical areas covered."

It's a big honor to be named to a DSMB.

But it's a no-no to brag about it, as one university recently found out.

The university proudly posted that one of its professors was named chair of the DSMB for the government-supported trials of coronavirus vaccines.

When CNN called to ask why the professor was publicly identified, the university quickly removed the press release.

"It looks like a staff member shared that news and was unaware that it was not for public consumption," a university spokesperson wrote to CNN.

CNN is not revealing the professor's name or the name of the university.

Despite the lack of public recognition, fame and glory, Ellenberg says there's plenty of motivation to serve on these boards.

"You feel a great responsibility when you're on these trials," she said. "Everybody's trusting you with these data."

She remains faithful in the DSMB process. If it goes as it's supposed to, "I would take the vaccine myself, and I would recommend that other people take it," she said.

Still, downstream from the DSMB, Ellenberg acknowledges "we're in uncharted territory."

Last week, President Trump claimed the White House can overrule the FDA's attempt to toughen its Covid-19 vaccine guidelines -- guidelines that could push hopes of a vaccine authorization past Election Day.

"It never occurred to anybody that anybody outside the FDA would would try and interfere with that," Ellenberg said. "And I'm hopeful that they won't."

More here:
The secretive group at the center of the nation's largest vaccine trials - WKTV

The University of Leeds has secured a 5.4 million grant to identify new techniques for investigating and manipulating the chemical building blocks of life - proteins.

The five-year project - in collaboration with the University of Oxford - will lead to a better understanding of fundamental biochemical processes and will identify new research strategies for tackling cancer and other diseases.

Andy Wilson, Professor of Organic Chemistry in the School of Chemistry at Leeds and principal investigator, said: The goal of this project is not only to get a better understanding of the way proteins work - but to establish how to disarm the rogue behaviour of some proteins that lead to disease.

Why proteins are so important

Proteins are the chemical workhorses that give cells their shape, structure and function.They are large molecules which can perform a range of cellular operations.

Although many regions of proteins adopt a fixed 3-D structure, many proteins found in the human body are able to change shape. This shape-shifting enables proteins to perform a range of different functions at different times.

The shape-shifting is linked to a part of the protein structure known as an intrinsically disordered region (IDR). The IDR changes shape and therefore its local interactions, dependent on the role it has in the cell at that particular moment.

The focus of the research project is to understand the mechanisms by which groups of IDRs change shape, revealing the role they play in a healthy cell and in the development of disease.

Understanding Aurora-A

The research project will investigate how a protein called Aurora-A is controlled by interactions involving IDRs. Aurora-A plays a role in several cellular processes that are relevant to human disease, including cell division, gene expression and the function of a hair-like projection from the cell surface called the primary cilium.

The involvement of Aurora-A in each process is dependent on a different shape-shifting protein interacting with it, but it is unclear how most of these interactions serve to control Aurora-A or how these different roles are coordinated.

Aurora-A is of major interest of Richard Bayliss, Professor of Molecular Medicine at Leeds and a co-investigator on the research project.

Professor Bayliss said: My team and others have been studying these individual interactions one-by-one for a long time.

This transformative project will enable us to understand how they fit together to produce a network that governs Aurora-As many cellular roles.

Professor Wilson added: We will deepen our understanding of the way Aurora-A is affected by changes in the shape of the proteins that interact with it.

Our aim is to develop new chemical and biological tools that will allow us to regulate the interaction of specific shape shifting proteins so we can identify the role they play in controlling Aurora-A.

By establishing the molecular processes that are most relevant to disease development and which shape-shifting proteins control these processes, targeted drug discovery efforts could be developed.

Collaborative research

In addition to ProfessorWilson and ProfessorBayliss, the research team includes other investigators based at Leeds who bring a wide range of expertise to the project: Dr Megan Wright, Dr Takashi Ochi, Dr Darren Tomlinson and Professor Sheena Radford, from the Astbury Centre for Structural Molecular Biology,andProfessorColin Johnson, in the School of Medicine.The final team member is Dr Fanni Gergely, a senior researcher and a leading cancer cell biologist based at the University of Oxford.

Professor Bayliss said: To tackle challenging scientific projects needs great team work, and we are fortunate to have so many outstanding colleagues who will contribute to our effort.

The academic scientists will work closely with industrial partners AstraZeneca and LifeArc to ensure rapid translation of research findings into drug discovery.

The researchers believe a better understanding of IDRs will have impact beyond cancer biology in many areas of biology including regulation of crop growth, cardiovascular biology and ageing.

Further information

Image credit: Professor Richard Bayliss. Illustration shows Aurora-A (light blue) and its three protein partners.

For further details, please contact David Lewis in the University of Leeds press office: d.lewis@leeds.ac.uk

Go here to read the rest:
News > Science > Understanding the way proteins shapeshift - University of Leeds

Newswise A major roadblock to large scale testing for coronavirus infection in the developing world is a shortage of key chemicals, or reagents, needed for the test, specifically the ones used to extract the viruss genetic material, or RNA.

A team of scientists at the University of Vermont, working in partnership with a group at the University of Washington, has developed a method of testing for the COVID-19 virus that doesnt make use of these chemicals but still delivers an accurate result, paving the way for inexpensive, widely available testing in both developing countries and industrialized nations like the United States, where reagent supplies are again in short supply.

The method for the test, published on Oct. 2 in PLOS Biology, omits the step in the widely used reverse transcription polymerase chain reaction (RT-PCR) test where the scarce reagents are needed.

92% accuracy, missing only lowest viral loads

The accuracy of the new test was evaluated by a team of researchers at the University of Washington led by Keith Jerome, director of the universitys Molecular Virology Lab, using 215 COVID-19 samples that RT-PCR tests had shown were positive, with a range of viral loads, and 30 that were negative.

It correctly identified 92% of the positive samples and 100% of the negatives.

The positive samples the new test failed to catch had very low levels of the virus. Public health experts increasingly believe that ultra-sensitive tests that identify individuals with even the smallest viral loads are not needed to slow spread of the disease.

It was a very positive result, said Jason Botten, an expert on pathogenic RNA viruses at the University of Vermonts Larner College of Medicine and senior author on the PLOS Biology paper. Bottens colleague Emily A. Bruce is the papers first author.

You can go for the perfect test, or you can use the one that's going to pick up the great majority of people and stop transmission, Botten said. If the game now is focused on trying to find people who are infectious, there's no reason why this test shouldn't be front and center, especially in developing countries where there are often limited testing programs because of reagent and other supply shortages.

Skipping a step

The standard PCR test has three steps, while this simpler version of the standard test has only two, Botten said.

In step 1 of the RT-PCR test, you take the swab with the nasal sample, clip the end and place it in a vial of liquid, or medium. Any virus on the swab will transfer from the swab into the medium, he said. In step 2, you take a small sample of the virus-containing medium and use chemical reagents, the ones that are often in short supply, to extract the viral RNA. In step 3, you use other chemicals to greatly amplify any viral genetic material that might be there. If virus was present, youll get a positive signal.

The new test skips the second step.

It takes a sample of the medium that held the nasal swab and goes directly to the third, amplification step, Botten said, removing the need for scarce RNA extraction reagents as well as significantly reducing the time, labor and costs required to extract viral RNA from the medium in step 2.

Botten said the test is ideally suited to screening programs, in both developed and developing countries, since it is inexpensive, takes much less processing time and reliably identifies those who are likely to spread the disease.

Its low cost and efficiency could extend testing capacity to groups not currently being tested, Botten said, including the asymptomatic, nursing home residents, essential workers and school children. The standard RT-PCR test could be reserved for groups, like health care workers, where close to 100% accuracy is essential.

An influential pre-print points way to widespread adoption of test

The two-step test developed by the University of Vermont team first caught the attention of the scientific community in March, when preliminary results that accurately identified six positive and three negative Vermont samples were published as a preprint in bioRxiv, an open access repository for the biological sciences. The preprint was downloaded 18,000 times in its first week, it ranked 17th among 15 million papers the site had published and the abstract was viewed 40,000 times.

Botten heard from labs around the world who had seen the preprint and wanted to learn more about the new test.

They said, I'm from Nigeria or the West Indies. We can't test, and people's lives are at stake. Can you help us?

Botten also heard from Syril Pettit, the director of HESI, the Health and Environmental Sciences Institute, a non-profit that marshals scientific expertise and methods to address a range of global health challenges, who had also seen the preprint.

Pettit asked Botten to join a think tank of likeminded scientists she was organizing whose goal was to increase global testing capacity for COVID-19. The test developed by the University of Vermont and University of Washington teams would serve as a centerpiece.

To catalyze a global response, the group published a call to action in EMBO Molecular Medicine.

And it took action, reaching out to 10 laboratories in seven countries, including Brazil, Chile, Malawi, Nigeria and Trinidad/Tobago, as well as the U.S. and France, to see if they would be interested in giving the two-step test a trial run.

Universally, the response was yes, Pettit said.

The outreach led to a new HESI program called PROPAGATE. Each of the labs in the PROPAGATE Network will use the two-step test on a series of positive and negative samples sent to them by the University of Washington to see if they can replicate the results the university achieved.

The study has already shown promising results. One of the labs in Chile has also used the test on its own samples from the community and got accurate results.

Assuming all goes well, Pettit and her colleagues at the University of Vermont and the University of Washington as well as scientists from the 10 partner sites plan to publish the results.

The goal is the make the two-step test accessible to any lab in the world facing these hurdles and see a broad uptake, she said.

See more here:
New COVID-19 Test Doesn't Use Scarce Reagents, Catches All But the Least Infectious - Newswise