Company: BDRX
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001214659-25-016821
Chunk: 46

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-17
Form: F-1
Chunk 46
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 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. Approximately 350 patients are diagnosed with medulloblastoma per annum and 3,800 people are living with the disease
in the United States. The cumulative survival rate is approximately 60%, 52%, and 47% at 5 years, 10 years, and 20 years, respectively;
however, recurrence is nearly always fatal with no established standard of care.

Due to resource constraints,
MTX110 has been de-prioritized in the three orphan brain cancer indications.

In 2020, our non-exclusive
worldwide, sublicensable license to certain patents of panobinostat was terminated by Secura Bio. We view MTX110 as an important asset
and we continue to enjoy freedom to use panobinostat for research purposes and we plan to continue to pursue development of MTX110. We
believe that the relevant Secura Bio patents may delay a launch of MTX110 for use in patients with DMG should the product receive accelerated
approval, however we do not anticipate it would have any impact on launching MTX110 for use in patients with GBM. If we are unable to
launch a product candidate until the patent expires, there could be a material adverse effect on our business, financial condition and
results of operations