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Marvel Biosciences Advances Closer to Human Trials After the Successful Completion of a Second Maximum Tolerated Dose Study, a Critical Milestone Towards FDA Clinical Studies
Calgary, Alberta--(Newsfile Corp. - October 25, 2022) - Marvel Biosciences Inc. (TSXV: MRVL) (...
About this update from Marvel Biosciences Corp
[{"type":"text","content":"Marvel Biosciences Advances Closer to Human Trials After the Successful Completion of a Second Maximum Tolerated Dose Study, a Critical Milestone Towards FDA Clinical StudiesCalgary, Alberta--(Newsfile Corp. - October 25, 2022) - Marvel Biosciences Inc. (TSXV: MRVL) (the \"Company\" or \"Marvel\") is pleased to announce it has completed its maximum tolerated dose (MTD) toxicology study in dogs for its product MB-204, further validating the Company's lead drug candidate low toxicity characteristic. \"We have now completed and further validated MB-204's safety profile through this recent dog toxicology study in addition to our recently press released toxicology study in rats,\" said Dr. Mark Williams, President and Chief Science Officer of Marvel Biosciences. \"We are now in the position to move to complete the 7-day dose ranging study and then our 4-week Good Laboratory Practice (GLP) toxicology study to allow us to test MB-204 in a human clinical trial,\" said Dr. Mark Williams, CSO of Marvel Biosciences.\"We continue to see an aging population that suffers from complex pathologies such as Alzheimer's Disease and depression and we are fully committed to deliver meaningful positive value to the lives of these patients,\" said Rod Matheson, Chief Executive Officer of Marvel Biosciences. \"So far, every study we have done continues to validate that we are on the right track with our lead candidate MB-204. We are very excited that this recent toxicology study has gotten us one step closer to beginning our human clinical trials within the first quarter of 2023.\"MTD toxicology studies define the highest dose of a drug or therapy that does not cause unacceptable side effects or toxicity. The purpose of the MTD study is to determine safe starting doses for first in-human (FIH) clinical trials. Marvel's unique formulation increases bioavailability and absorption rate of the drug by the body. As a result, the dogs in the tests were able to successfully be exposed to the drug on a high dosage of MB-204 without adverse effects. The proven low toxicity of the MB-204 provides the Company with a great degree of confidence to enter human trials and begin the process of getting MB-204 approved by the FDA.MB-204 is the Company's lead compound and is a novel fluorinated form of Istradefylline (FDA approved anti-Parkinson's disease drug) and is a ...