Company: BDRX
Filing Date: 2025-01-28
Form Type: 424B3
Source: 0001214659-25-001409
Chunk: 163

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-01-28
Form: 424B3
Chunk 163
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 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.

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The
University of Texas is undertaking a Phase 1 exploratory study in recurrent medulloblastoma patients using direct administration of MTX110
into the fourth ventricle, enabling it to circulate throughout the CSF.

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 currently have two ongoing clinical trials for MTX110 and intend to commence two further clinical trials as
part of our MTX110 clinical program. 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