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Marvel Biosciences Achieves CGMP Milestone and Begins IND-Enabling Pre-Clinical Toxicology Testing of Lead Compound
Calgary, Alberta--(Newsfile Corp. - December 8, 2021) - Marvel Biosciences Corp. (TSXV: MRVL...
About this update from Marvel Biosciences Corp
[{"type":"text","content":"Marvel Biosciences Achieves CGMP Milestone and Begins IND-Enabling Pre-Clinical Toxicology Testing of Lead CompoundCalgary, Alberta--(Newsfile Corp. - December 8, 2021) - 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 pre-clinical investigational new drug (\"IND\") enabling toxicology studies for its lead compound MB-204 with Pharmaron, Inc. (\"Pharmaron\"), with its principal office in Louisville, Kentucky.Pharmaron, one of the world's largest contract research organizations, has begun testing of MB-204, initiating the maximum tolerated dosing studies, which is expected to be completed in Q1 2022. In addition, the four-week good lab practice (\"GLP\") studies, which allows the study of the lead compound over a longer exposure time is also scheduled to complete in Q3 2022.\"This is another important milestone for Marvel as we transition in a short period of time from a pre-clinical company to a clinical company,\" stated Dr. Mark Williams, President and Chief Science Officer. \"Our goal has been to move from lead identification to dosing in humans in less than two years, and we are on track to deliver on that vision.\"Rod Matheson, Chief Executive Officer, further added, \"To date we have shown in a number of pre-clinical studies the level of efficacy and safety MB-204 can deliver with the partnership with Ausun. As we move to the next phase of our pre-clinical development with Pharmaron, we have now entered a key and very important stage in the development of MB-204 to drive this asset into clinical studies. This new milestone is key in further advancing our discussions with potential commercial partners to ensure the best outcome for our shareholders.\" Marvel's lead compound asset MB-204 (\"MB-204\") is being developed for neurological conditions such as depression and anxiety, Alzheimer's, ADHD and NASH. Marvel's compound is a novel patented fluorinated derivative of the US-FDA approved Parkinson's disease drug Istradefylline (Nourianz®). Both Istradefylline and MB-204 are highly active derivatives of caffeine, which act as antagonists of the adenosine A2a receptor (\"A2aR\"). Caffeine is the most widely consumed psychoactive drug in the world and has been associated with a red...