Friday, Biodexa Pharmaceuticals PLC BDRX announced an R&D update, including topline clinical trial results of a recently completed Phase 1 study of MTX110 in patients with diffuse midline glioma (DMG).
In an investigator-initiated study conducted by Columbia University Irving Medical Center, patients newly diagnosed with DMG were administered MTX110 via convection-enhanced delivery (CED) using a subcutaneous pump connected to a catheter directly implanted into the pons in a 3+3 dose-escalating design.
Nine patients were treated in the study (30 M group, n=3; 60 M group, n=4; 90 M group (optimal dose), n=2).
One patient in the 60 M group suffered a severe adverse event assessed by the investigators as not related to the study drug but related to the infusion and tumor anatomy.
Although the study was not powered to reliably demonstrate efficacy, the median overall survival (OS) was 16.5 months, compared favorably with the median survival rate in a cohort of 316 cases of 10.0 months.
The company also shared the results of a preclinical experiment designed to demonstrate tolimidone’s potential for beta cell proliferation in an in vitro model.
The results were inconclusive in that they did not correlate with the results previously seen in in vitro and in vivo studies of tolimidone.
The company says there are a few possible explanations for the outcome of this in vitro study and, accordingly, plans to move ahead rapidly with an in vivo preclinical study with similar objectives while continuing preparations for its planned Phase 2a open-label study of tolimidone in patients with Type 1 diabetes due to start recruitment later this year.
Price Action: BDRX shares are down 9.08% at $1.40 on the last check Friday.
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