Revive Therapeutics Engages Pharma-Olam and Strengthens Infectious Diseases Clinical Development Team to Advance U.S. FDA Clinical Study for COVID-19
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TORONTO, March 25, 2020 (GLOBE NEWSWIRE) — Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases, is pleased to announce that the Company has retained Pharm-Olam, LLC, with proven clinical experience in infectious diseases completing over 100 clinical studies in approximately 19,000 patients at over 2,000 clinical sites, to serve as the Company’s Contract Research Organization (“CRO”) to advance the future clinical study for Bucillamine in the treatment of infectious diseases, including the coronavirus disease (“COVID-19”). In addition, Revive has added Dr. Kelly McKee, Jr., MD, MPH as Chief Scientific Officer consultant and Dr. Onesmo Mpanju, PhD as Regulatory Affairs consultant to the Company’s clinical development team.
“We are very pleased to have Pharm-Olam as our partner in guiding us towards our goal to investigate Bucillamine as a potential treatment for COVID-19 in a U.S. FDA clinical study and in other infectious diseases clinical studies in the future,” said Michael Frank, Chief Executive Officer of Revive. “Pharm-Olam has the proven experience in managing infectious disease clinical studies, a scalable ecosystem for expediting and completing clinical studies on time and on budget, and most importantly they have an infectious disease team of experts with the addition of Dr. McKee and Dr. Mpanju who will develop and oversee Revive’s clinical study and its expeditious submission of our IND with the FDA.”
Dr. McKee is currently Senior Scientific and Medical Advisor for Pharm-Olam. Previously, Dr. McKee served Pharm-Olam’s Chief Medical Officer, and as Vice President, Vaccines and Public Health, in the Infectious Diseases and Vaccines Center of Excellence at IQVIA (previously QuintilesIMS). He brings over 30 years of experience in research and development from the bench to the bedside, with specific expertise in vaccines, emerging diseases, biodefense, respiratory viral infections, and sexually transmitted infections. His progressive clinical research experience began in 1981 at Fort Detrick, Frederick, Md., United States, where he served as a research virologist, immunologist, and Head of the Dept of Clinical Investigation and Medical Division at the US Army Medical Research Institute of Infectious Diseases (USAMRIID).
Dr. Onesmo Mpanju, PhD has over 28 years of experience in biopharmaceutical R&D, including 18 years as a regulatory scientist. Previously, Dr. Mpanju was a Reviewer at the U.S. FDA, Center for Biologics Evaluation & Research. His consulting experience includes non-commercial entities such as the U.S. National Institutes of Health, US Army Medical Materiel Development Activity (USAMMDA), the Bill & Melinda Gates Foundation, and others. Dr. Mpanju holds a Ph.D. in Experimental Medicine (Infectious Diseases) from the University of British Columbia, Vancouver, Canada.
About Pharm-Olam, LLC.
Pharm-Olam is Helping Create a Healthier World as a global, midsized CRO that offers flexible, innovative, and highly personalized clinical solutions to pharmaceutical, biotechnology, and life science companies. The Company is well-known for producing quality results with reduced risk, costs, and timelines in challenging international trials. Learn more about their full-service solutions, data protection services, and expertise in oncology, infectious diseases and vaccines, rare and orphan diseases, pediatrics, and general medicine at pharm-olam.com.
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for rare disorders and infectious diseases. Revive’s technology is being advanced to fill the medical needs for diseases and disorders such as pain, inflammation, and wound care. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory areas such as liver disease. The Company was granted FDA orphan drug status designation for the use of CBD to treat auto-immune hepatitis (liver disease) and FDA orphan drug status designation for the use of CBD to treat ischemia and reperfusion injury from organ transplantation. With its recent acquisition of Psilocin Pharma Corp., Revive will advance Psilocybin-based therapeutics in various diseases and disorders and will prioritize development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. The Company is also exploring the use of Bucillamine for the potential treatment of infectious diseases. For more information visit www.ReviveThera.com.
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Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Offering, including the intended use of proceeds. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
Source: Revive Therapeutics Ltd.