Company: BDRX
Filing Date: 2025-01-17
Form Type: F-1
Source: 0001214659-25-000922
Chunk: 164

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-17
Form: F-1
Chunk 164
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 process of recruiting patients in a Phase 1 study to assess the utility of MTX110 in recurrent
GBM. The Phase 1 study is an open-label, dose escalation study designed to assess the feasibility and safety of intermittent infusions
of MTX110 administered by CED via implanted refillable pump and catheter. The study aims to recruit two cohorts, each with a minimum of
four patients; the first cohort will receive MTX110 only and the second cohort will receive MTX110 but with the option of the treating
investigator to re-position the catheter into an area of new lesion upon progression, with the objective of increasing tumor coverage
and survival.

Diffuse Midline Glioma (DMG):DMG, formerly known as diffuse intrinsic pontine glioma (DIPG), tumors are located in the pons (middle)
of the brain stem and are diffusely infiltrating. Occurring mostly in children, approximately 1,100 patients worldwide and 300 in the
United States are diagnosed with DMG per annum and median survival is approximately 10 months. There is no effective treatment since surgical
resection is not possible. The standard of care is radiotherapy, which transiently improves symptoms and survival. Chemotherapy does not
improve survival and one likely reason is that many anti-cancer drugs cannot cross the blood-brain barrier to access the tumor.

In
October 2020, we reported the first-in-human study by the University of California, San Francisco of MTX110 in DMG using a CED system.
The Phase 1 study established a recommended dose range for Phase 2, a good safety and tolerability profile but also encouraging survival
data in the seven patients treated.

In
February 2024 we announced top line results from the Investigator-Initiated Study of MTX110 in pediatric patients with DMG conducted by
Columbia University Irving Medical Center. Nine patients were treated in the study (30 mM group,
n=3; 60 mM group, n=4; 90 mM group (optimal dose), n=2).
One patient in the 60 mM 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. Median progression free survival was 10 months from diagnosis
(PFS=12) while median overall survival was 16.5 months (OS=16.5).

Medulloblastoma:Medulloblastomas
are malignant