Marvel Biosciences Successfully Completes Maximum Tolerated Dose Study, a Critical Milestone Towards FDA Clinical Studies
Calgary, Alberta--(Newsfile Corp. - October 17, 2022) - Marvel Biosciences Inc. (TSXV: MRVL) (the "Company" or "Marvel") is pleased to announce it has completed its maximum tolerated dose (MTD) toxicology study for its product MB-204, validating its low toxicity.
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 blood brain barrier permeable adenosine A2a receptor antagonist. Marvel is developing MB-204 for the treatment of depression and Alzheimer's Disease, as well NASH associated liver fibrosis.
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. The Company used a unique formulation to increase oral bioavailability, which drove high absorption of the drug by the body. As a result, the rats that were used in the study were exposed to very high acute dosage of MB-204 and their bodies were able to tolerate this high dosage. The low toxicity of the Company's lead product is a positive indication of what to expect in future clinical studies and the Company's ability to move its key drug candidate successfully through the FDA approval process.
"Our primary goal is to continue de-risking our key asset MB-204 and bring the product to a stage where a meaningful business partnership can be established with a major biotech player," said Rod Matheson, Chief Executive Officer of Marvel Biosciences. "In order for us to accomplish this goal, there are a number of important milestones we need to deliver on that will allow us to bring MB-204 into human clinical studies, and this toxicology study is one of those pivotal milestones."
"Based on the safety profile of Istradefylline, we expected MB-204 to be well tolerated," said Dr. Mark Williams, Chief Science Officer of Marvel. "We are moving to complete our 7-day dose ranging study and then our 4-week Good Laboratory Practice (GLP) toxicology study to allow us to test MB-204 in the clinic, all of which is now one step closer to fruition. We are also conducting similar studies in dogs. In parallel we have begun the cGMP synthesis of MB-204 in order to produce enough drug for clinical testing."
Mr. Matheson continued, "The positive results that we received from our MTD toxicology study continues to keep us on track to enter human trials by early 2023. So far, all of our studies on MB-204 have displayed significant positive impact on our target indications. We are extremely excited that Marvel is on track to deliver a world class product that improves the life of patients suffering from growing mental health and neurological disorders."
Contact Information
Investor Relations:
Virtus Advisory Group
Tel: 416-644-5081
Email: info@virtusadvisory.com
Marvel Biosciences Corp.
Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President, and Chief Science Officer
Tel: 403 770 2469
Email: info@marvelbiosciences.com
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All information contained in this news release with respect to the Company and its subsidiary, (collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and officers have relied on each other for any information concerning such Party.
This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the expectations of the Company and include other risks detailed from time to time in the filings made by the Company under securities regulations.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law.
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