Revive Therapeutics Advances Research Program of Cannabinoid-Based Therapies Targeting Liver Diseases
Revive Therapeutics Ltd. (“Revive” or the “Company”) (TSX VENTURE:RVV) (OTCQB:RVVTF), a company focused on the research, development and commercialization of novel cannabinoid solutions, today announced the advancement of the research program to evaluate Cannabidiol (“CBD”) in the treatment of Autoimmune Hepatitis (“AIH”), a rare liver disease. The research will be overseen by Sanyal Biotechnology LLC (“SanyalBio”), the Company’s strategic research partner for liver diseases.
“We are very excited to advance the development of cannabidiol for the potential treatment of autoimmune hepatitis with Sanyal Biotechnology,” said Fabio Chianelli, President of Revive. “The research will not only serve as a foundation for future clinical research in autoimmune hepatitis, but also it will set the path forward in expanding our knowledge of cannabinoids for the potential treatment of rare liver diseases and in large liver disease market opportunities such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), and fibrosis.”
“We are very excited to work along with Revive in their goal of commercializing novel cannabinoid solutions for autoimmune hepatitis and other liver diseases,” said Dr. Arun Sanyal, MD, Scientific Advisor for Revive and co-founder and Chief Medical Officer of Sanyal Biotechnology LLC. “SanyalBio will use its proprietary DIAMOND™ mouse model to fully understand the mechanism of action of cannabidiol in autoimmune hepatitis and these results will serve as a strong foundation for advancing a potential new treatment option for autoimmune hepatitis and other liver diseases.”
The research program will be led by SanyalBio’s scientific team, including Dr. Rebecca Caffrey and Dr. Arun Sanyal, M.D. The focus will be on the use of cannabidiol on a novel autoimmune hepatitis model based on the DIAMOND™ model designed and developed by SanyalBio specifically for Revive. The research program is expected to generate a better model of AIH which will enable SanyalBio to further advance the research of cannabinoids for the treatment of AIH and other liver diseases, and the research will provide meaningful information to support future clinical research and partnering discussions for Revive.
About Liver Disease
Liver disease is described by irregular functioning of liver, causing disorders like hepatitis, fatty liver, and cirrhosis. There are over 100 described diseases of the liver affecting at least 30 million people alone in the U.S. A number of factors are driving the liver disease treatment market, which includes rapidly changing lifestyle patterns such as increasing alcohol consumption, unhealthy diets, and increasing prevalence of liver diseases. Liver diseases can result from injury to the liver caused by hepatitis C virus (HCV), hepatitis B virus (HBV), obesity, chronic excessive alcohol use or autoimmune diseases. Major drug categories used in the treatment of liver diseases includes anti-rejection drugs, vaccines, immunosuppressant, chemotherapy drugs and antiviral drugs. According to Allied Market Research, titled, “World Liver Disease Treatment Market – Opportunities and Forecast, 2014 – 2022”, the global market for liver disease treatment is projected to reach $19,536 million by 2022.
About Autoimmune Hepatitis
AIH is a rare autoimmune disease, causing inflammation to the liver, which not treated properly, may cause liver fibrosis or cirrhosis, liver failure requiring a liver transplant, and even death. The prevalence of AIH is estimated at 75,000 patients in the U.S. The current standard of care for AIH is the use of steroids alone or steroids combined with azathioprine. It has been noted in medical literature that the current standard of care when used in a certain period of time has caused severe treatment-related side effects in 13%, treatment failure in 9%, incomplete response in 13%, and relapse after drug withdrawal up to 86% of patients with AIH (Source: World J Gastroenterol. 2010 Feb 28; 16(8): 934-947). Therefore, given the unwanted outcomes associated with a steroid-based therapy, an alternative steroid-free treatment option such as CBD, with its known safety profile, may provide a potential solution for an improved treatment strategy for those patients unresponsive to, intolerant of, or non-adherent with a steroid-based therapy for AIH.
About Revive Therapeutics Ltd.
Revive Therapeutics Ltd. (TSX VENTURE:RVV) (OTCQB:RVVTF) is focused on the research, development and commercialization of novel therapies and technologies for the medical cannabis and cannabinoid-based pharmaceutical markets. Additional information on Revive is available at www.ReviveThera.com
For more information please contact:
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: (416) 272-5525
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Neither the TSX-V nor its Regulation Services Provider (as that term is defined in the policies of the TSX-V) accepts responsibility for the adequacy or accuracy of this release.
This news release includes certain information and statements about management’s view of future events, expectations, plans and prospects that constitute “forward-looking information” that involves known and unknown risks and uncertainties, which are not comprised of historical facts, and most of which are beyond the control of Revive. Forward-looking statements include estimates and statements that describe Revive’s future plans, objectives or goals, including words to the effect that Revive or its management expects a stated condition or result to occur. Forward-looking statements may be identified by such terms as “believes”, “anticipates”, “intends”, “expects”, “estimates”, “may”, “could”, “would”, “will”, or “plan”, and similar expressions. Specifically, forward-looking statements in this news release include, without limitation, statements regarding: the granting of a patent for Bucillamine for the treatment of gout; the potential efficacy and commercial viability of Bucillamine for treatment of gout and Bucillamine for the treatment of Cystinuria; expansion of the Bucillamine clinical testing program; the Company’s drug research and development, and commercialization plans; the Company’s research, development and commercialization plans for plant-based therapies, including cannabinoids; the timing of operations; and estimates of market conditions. These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results or events, performance, or achievements of Revive to differ materially from those anticipated or implied in such forward-looking statements. Since forward-looking statements are based on assumptions and address future events and conditions, by their very nature they involve inherent risks and uncertainties. The Company believes that the expectations reflected in these forward-looking statements are reasonable, but there can be no assurance that actual results will meet management’s expectations. In formulating the forward-looking statements contained herein, management has assumed: that business and economic conditions affecting Revive will continue substantially in the ordinary course and will be favourable to Revive; that clinical testing results will justify commercialization of the Company’s drug candidates; that Revive will be able to obtain all requisite regulatory approvals to commercialize its drug candidates; that such approvals will be received on a timely basis; and, that Revive will be able to find suitable partners for development and commercialization of its drug repurposing candidates on favourable terms. Although these assumptions were considered reasonable by management at the time of preparation, they may prove to be incorrectand no assurance can be given that such events will occur in the disclosed time frames or at all.
Factors that may cause actual results to differ materially from those anticipated by these forward-looking statements include: uncertainties associated with obtaining regulatory approval to perform clinical trials and market products; the need to establish additional corporate collaborations, distribution or licensing arrangements; the Company’s ability to raise additional capital if and when necessary; intellectual property disputes; increased competition from pharmaceutical and biotechnology companies; changes in equity markets, inflation, and changes in exchange rates; and other factors as described in detail in Revive’s Management’s Discussion & Analysis for the period ended June 30, 2017 and Revive’s other public filings, all of which may be viewed on SEDAR (www.sedar.com). Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. Except as required by law, Revive disclaims any intention and assumes no obligation to update or revise any forward-looking statements to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking statements or otherwise.