Company: BDRX
Filing Date: 2025-12-11
Form Type: F-1/A
Source: 0001214659-25-017944
Chunk: 39

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-12-11
Form: F-1/A
Chunk 39
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 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.

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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 embryonal tumors that start in the cerebellum. They are invasive and, unlike most brain tumors, spread through the cerebrospinal
fluid, or CSF, and frequently metastasize to different locations in the brain and spinal cord. Treatments include resection, radiation
and chemotherapy