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Marvel Biosciences Corp. (TSXV: MRVL | OTCQB: MBCOF), and its wholly-owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), a drug discovery company developing novel therapeutics for autism spectrum disorder ("ASD") and related neurodevelopmental disorders, is pleased to announce that it has selected CMAX as the Phase I clinical site to test its lead drug candidate MB-204, an important step in the Company's preparations to advance its lead patented drug candidate toward first-in-human clinical evaluation.
CMAX Clinical Research is an independent clinical research facility, based in Adelaide, Australia. CMAX has been established as a Phase I unit since December 1993, making it the longest-running in Australia and, since establishment, has consistently maintained world class standards with a total commitment to providing excellence and quality in all areas of clinical service. CMAX is also one of Australia's most modern Phase I clinical facilities, adjacent to Adelaide's Biomed City. The facility offers 78‐bed capacity for in‐house stays and conducts >40 studies per year. The CMAX site specialises in Phase I – FTIH, SAD/MAD, first time in patients, BA/BE, PK/PD and Proof-Of-Concept studies. CMAX has conducted >600 studies since the unit was established.
Marvel's preparations for clinical development are supported by a growing body of preclinical research evaluating MB-204 across multiple genetically distinct models of neurodevelopmental disorders. The Company has reported behavioural and cognitive improvements in mouse models associated with Rett syndrome (Mecp2), Fragile X syndrome (Fmr1) and autism spectrum disorder (Oprm1), alongside preliminary findings from a Shank3 mouse model associated with Phelan-McDermid syndrome. In its August 2026 Fragile X study, Marvel reported statistically significant improvements in recognition memory at both tested doses and persistent effects on selected endpoints following treatment cessation (refer to press release dated August 5, 2026). Preliminary Shank3 findings also indicated improvements across multiple behavioural measures, although final statistical analyses and additional endpoints remained pending at the time of that announcement (refer to press release dated October 8, 2026).
"We are pleased to be working with CMAX and Novotech as our clinical partners for the Phase I trial of MB-204", commented Dr. Mark Williams, Chief Science Officer of Marvel Biosciences. "We look forward to navigating the ethics approval and regulatory process with both groups to start clinical testing."
The selection of CMAX represents an important operational step in Marvel's preparations to advance MB-204 toward first-in-human clinical evaluation. As previously disclosed, the Company is planning a Phase I program beginning with a single ascending dose (SAD) study designed to evaluate the candidate's initial safety, tolerability and pharmacokinetic profile in humans. The planned study is also expected to assess potential biomarkers and selected cognitive endpoints, with findings intended to inform the design of a subsequent multiple ascending dose (MAD) study. Initiation of the trial remains subject to applicable regulatory and ethics approvals and completion of the necessary clinical preparations.
About Marvel Biosciences Corp.
Marvel Biosciences Corp. (TSXV:MRVL | OTCQB:MBCOF), and its wholly-owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pharmaceutical development biotechnology company entering Phase 1 clinical stage. The Company is developing MB-204, a novel fluorinated derivative of the approved anti-Parkinson's drug Istradefylline, the only clinically approved adenosine A2a antagonist. A significant and growing body of scientific evidence suggests drugs that block the adenosine A2a receptor, such as MB-204, could be useful in treating other neurological diseases such as autism, depression and Alzheimer's Disease. The Company is actively investigating its potential in addressing other neurodevelopmental disorders, such as Rett Syndrome and Fragile X Syndrome, to expand its therapeutic reach.
Contact Information: Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer
Email: rod@marvelbiosciences.com
Dr. Mark Williams, President and Chief Science Officer
Email: mark@marvelbiosciences.com
Tel: 403 770 2469
Website: www.marvelbiotechnology.com | Twitter/X | LinkedIn
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release. 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.
