Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company“ or “Marvel“), is pleased to announce that it has initiated its 7-day dose-ranging, toxicology study, using rats, for its lead molecule MB-204. This is a vital step in preparation to initiate FDA Phase I human clinical trials.
“We have significantly de-risked the development of our lead drug candidate MB-204 and have a strong understanding of its safety and risk profile, as we have redeveloped this candidate from an existing FDA-approved drug Istradefylline,” said Rod Matheson, Chief Executive Officer. “We are on time and on budget to enter FDA Phase I human trials by early 2023. MB-204 will be highly disruptive to the existing market and, we believe, will be a welcomed therapy for patients who suffer from Alzheimer’s Disease and Depression. Our studies, as noted in previous press releases, have been extremely encouraging and we look forward to introducing a novel product that we have full commercial rights to for a very large and growing market that is in real need of a new and effective approach to treatment.”
After completing the maximum tolerated single dose studies, the FDA requires another short study before entering the industry standard Good Lab Practice (GLP) toxicology studies. This study requires toxicology studies in two species, typically rats and dogs, to test the safety of new drugs before being able to run trials on humans.
“This is the final milestone experiment we need to execute in order to identify the optimal doses for our upcoming 4-week GLP rat study, which in combination with our dog studies, will allow us to start human clinical testing of MB-204,” said Dr. Mark Williams, Chief Science Officer. “We are commencing the dog dose ranging study shortly and will update the market on our progress shortly thereafter.”
MB-204 is a fluorinated derivative of the U.S. FDA approved adenosine A2a receptor antagonist, Istradefylline. Both Istradefylline and MB-204 are highly active derivatives of caffeine, the most widely consumed psychoactive drug in the world. Caffeine consumption has been associated with a reduced risk for developing Parkinson’s disease, Alzheimer’s disease and improving mood and concentration.
About Marvel Biosciences Corp.
Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pre-clinical stage pharmaceutical development biotechnology company that utilizes a “drug redevelopment” approach to drug development. Historically, when a new class of drug is developed, it is optimized for a particular target, but typically only approved for a specific disease. Often, a new disease is identified which involves the same target, however, pending the remaining patent life, the originally approved drug may not have sufficient time left for it to be commercially viable to be developed for the new disease indication. Marvel develops new synthetic chemical derivatives of the original approved drug for the new disease indication. Patent protection is sought, as the new potential asset is developed by the Company. The Company believes the business model results in significantly less risk, cost and time to develop its assets compared to traditional biotechnology companies.
Marvel Biotechnology Inc. has currently developed several new chemical entities, using synthetic chemical derivatives of known, off-patent drugs, that inhibit the A2a adenosine receptor with application to neurological diseases (depression & anxiety, Alzheimer’s, ADHD), and the non-neurological conditions of cancer and non-alcoholic steatohepatitis. Marvel is also exploring additional undisclosed targets to expand its asset pipeline.
Investor Relations Marvel Biosciences Corp.
Virtus Advisory Group Roderick (Rod) Matheson, Chief Executive Officer or
Tel: 416-644-5081 Dr. Mark Williams, President, and Chief Science Officer
Tel: 403 770 2469
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