Company: BDRX
Filing Date: 2025-05-01
Form Type: DRS
Source: 0001214659-25-006756
Chunk: 38

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-05-01
Form: DRS
Chunk 38
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 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).

: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.

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 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.

Commercial Agreements, Strategic Partnerships and Collaborations

We are currently collaborating
with biopharmaceutical companies, contract research organizations and universities on several of our development programs.

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