CARDIFF, United Kingdom - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a biopharmaceutical company focusing on unmet medical needs, announced positive outcomes from its Phase 1 clinical trial of MTX110 in treating diffuse midline glioma (DMG). The trial, initiated by Columbia University Irving Medical Center, tested the safety and tolerability of MTX110 delivered directly to the brainstem using a novel method in patients with DMG.
The study used a 3+3 dose-escalating design, treating nine patients with two infusions of MTX110 seven days apart. Despite its primary goal being to assess safety, the trial noted a median overall survival of 16.5 months among participants, compared to a historical 10.0-month median survival in a similar cohort.
While one patient experienced a severe adverse event, it was deemed unrelated to the drug. These preliminary findings are expected to be presented in detail at the 21st International Symposium on Pediatric Neuro-Oncology in Philadelphia, PA, from June 28-July 2, 2024.
In addition, Biodexa provided an update on tolimidone, aimed at Type 1 diabetes treatment. A recent in vitro study conducted by a Contract Research Organization (CRO) yielded inconclusive results on beta cell proliferation. However, the company plans to proceed with an in vivo preclinical study and is preparing for a Phase IIa study set to begin recruitment later this year.
Biodexa's pipeline includes tolimidone, an oral agent for Type 1 diabetes, and MTX110 for rare/orphan brain cancers. MTX110 is a formulation of panobinostat, an HDAC inhibitor, delivered directly to tumor sites, potentially reducing systemic toxicity.
This announcement is based on a press release statement by Biodexa Pharmaceuticals PLC. The company's future plans and clinical developments are subject to various risks and uncertainties, as noted in their forward-looking statements.
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