Marvel Biosciences Initiates Its Final FDA-Required Experiment Prior to Initiating Human Trials for Its Lead Drug Candidate MB-204
Calgary, Alberta–(Newsfile Corp. – December 12, 2022) – Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company“ or “Marvel“), announces it has initiated its 10-day, dose-ranging toxicology study, using dogs, for its lead drug candidate MB-204.
To date, the Company’s MB-204 has shown positive and promising data addressing depression, anxiety as well as its potential benefit in protecting patient’s vital organs while going through chemotherapy treatments. As the maximum tolerated single-dose studies have been completed, FDA guidelines for drug development next prescribe an approximately one-week multiple dosing study required to run the industry standard 4-week good lab practise (GLP) toxicology studies. The studies are all required by the FDA prior to entering FDA Phase I human trials.
“We continue to achieve our milestones in a timely fashion and have made great progress in getting our key asset, MB-204 ready to enter human trials in early 2023,” said Rod Matheson, CEO of Marvel Biosciences. “MB-204 has the potential to target a very significant market and we will continue to closely monitor the effects of this lead asset drug and will seek all opportunities to maximize shareholder value from our key asset.”
“This is the final milestone we need to run to identify the best doses in our upcoming 4-week GLP dog study, which in combination with our rat studies, will enable us to commence human clinical testing of MB-204,” said Dr. Mark Williams, Chief Science Officer. “We are close to completing the 7-day dose-ranging study using rats as well and will update our stakeholders on our progress shortly.”
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 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.
Virtus Advisory Group
Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469
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