Marvel Successfully Completes the Dog and Rat GLP Toxicology Studies Required to Enter Human Trials
Calgary, Alberta--(Newsfile Corp. - April 20, 2023) - 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 completed the dosing portion of the 4-week good laboratory practice (GLP) FDA investigational new drug (IND) enabling dose-ranging dog and rat studies for its lead drug candidate MB-204.
"We are pleased to report we have now completed treating both rats and dogs with multiple doses of MB-204 for this pivotal study and we have now entered the 4 week recovery period before we begin harvesting results from this study," said Dr. Mark Williams, Chief Science Officer of Marvel Biosciences. "We expect full data from this study to be ready within three months following the completion of the recovery period, which if positive, will allow us to initiate our Phase 1 human trials."
"We look forward to receiving the toxicological data for MB-204 as we continue preparing for human trials targeting the third quarter of this year," said Rod Matheson, CEO of Marvel Biosciences. "We believe the chemical changes we made to Istradefylline will enable our lead drug candidate MB-204 to retain the safety and efficacy that we have observed in Istradefylline, however MB-204 has already shown in a number of our studies to play an effective role in addressing symptoms associated with depression, in addition to targeting a receptor that has shown to play a pivotal role in Alzheimer's disease."
In the United States, it is estimated that one in ten senior citizens over the age of 65 suffer from dementia. MB-204 is a novel solution to Alzheimer's that has similar properties to the Food and Drug Administration-approved drug, Istradefylline. MB-204 has, through the Company's studies, proven to be more effective and longer lasting than Istradefylline in pre-clinical studies.
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 of developing Parkinson's disease, and Alzheimer's disease and improved 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
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