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Marvel Biosciences Successfully Completes Engineering Run of Its Lead Asset Targeting Alzheimer's Further Advancing Towards FDA Phase I Human Trials
Calgary, Alberta--(Newsfile Corp. - November 1, 2022) - Marvel Biosciences Corp. (TSXV: MRVL)...
About this update from Marvel Biosciences Corp
[{"type":"text","content":"Marvel Biosciences Successfully Completes Engineering Run of Its Lead Asset Targeting Alzheimer's Further Advancing Towards FDA Phase I Human TrialsCalgary, Alberta--(Newsfile Corp. - November 1, 2022) - Marvel Biosciences Corp. (TSXV: MRVL) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the \"Company\" or \"Marvel\"), announces it has successfully completed a large-scale engineering run of its novel solid amorphous dispersion (SAD) formulation of MB-204 by Zhejiang Ausun Pharmaceutical Co., Ltd. (\"Ausun\"). The engineering run material will be utilized to support the ongoing toxicology studies of MB-204 being conducted by Pharmaron Inc. The engineering run is a key step forward to manufacturing the Company's lead product at a large scale for FDA Phase I human trials. An engineering run is a trial run of a small batch sample demonstrating the manufacturing process and resolving any potential issues before entering formal cGMP documentation and activities. The Company previously reported a highly significant increase in drug exposures in pre-clinical testing using the SAD formulation. This formulation involves coating MB-204 in a special FDA approved sugar-like polymer (similar to starch for example). This novel formulation could potentially reduce the amount of drug needed for human dosing, thereby improving the economics for Marvel.\"We are very pleased with our manufacturing partner Ausun for achieving another manufacturing milestone,\" said Rod Matheson, Chief Executive Officer. \"The company is advancing effectively to the clinic, and we look forward to updating the market with news on our toxicology studies 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 ...