Marvel Announces Successful Completion of Toxicology Study in Preparation for Phase 1 Human Trials
- Successful completion of GLP studies establishes dosing and exposure ranges with No Adverse Event Levels (NOAEL's)
- MB-204 shows potential to be active after a single dose, shortening Phase 1 timeline
- None.
Calgary, 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, 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.
Contact Information
Investor Relations:
Virtus Advisory Group
Tel: 416-646-6779
Email: info@virtusadvisory.com
Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469
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