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Marvel Announces Successful Completion of Toxicology Study in Preparation for Phase 1 Human Trials
Calgary, Alberta--(Newsfile Corp. - August 22, 2023) - Marvel Biosciences Corp. (TSXV: MRVL) (OT...
About this update from Marvel Biosciences Corp
[{"type":"text","content":"Marvel Announces Successful Completion of Toxicology Study in Preparation for Phase 1 Human TrialsCalgary, Alberta--(Newsfile Corp. - August 22, 2023) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the \"Company\" or \"Marvel\"), is pleased to announce that it has successfully completed its 4-week good laboratory practice (GLP), FDA investigational new drug (IND), dose-ranging dog and rat studies for its lead drug candidate MB-204 paving the way for Phase 1 human trials to begin. \"We are very pleased to announce that the findings from our GLP studies have established the dosing and exposure ranges associated with No Adverse Event Levels (NOAEL's) in both the rat and dog studies,\" said Dr. Mark Williams, President of Marvel Biosciences. \"The successful results of these studies will officially enable us to advance into Phase 1 human trials and an FDA IND submission. We are now preparing for a Phase 1 study in Australia and will report on the timing of the trial shortly.\"Dr. Williams continued, \"What is particularly exciting about MB-204, supported by our recent pre-clinical work, is that it has shown the potential to be active after a single administered dose. This is significant, as we would be able to harvest valuable data about the safety and efficacy of our drug candidate at a much faster rate relative to typical drug candidates requiring multiple dosages to establish baseline data. Importantly, as a result of this discovery, we could be in a position to materially shorten the Phase 1 timeline providing an opening to engage with strategic partners sooner.\"\"Our drug re-development approach, which takes an existing approved drug, and makes the logical modifications to develop it for a new disease is nearing its fruition,\" said Rod Matheson, Chief executive officer of Marvel. \"We believe MB-204 has the potential to be a first-in-class treatment option for Alzheimer's disease, depression, and possibly ADHD.\"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, an...