Company: BDRX
Filing Date: 2025-11-17
Form Type: F-1
Source: 0001214659-25-016821
Chunk: 45

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-11-17
Form: F-1
Chunk 45
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iforme (GBM):GBM is the most common and aggressive form of brain cancer in adults, usually occurring in the white matter of
the cerebrum. Treatments include radiation, surgical resection and chemotherapy although, in almost all cases, tumors recur. Based on
available date from the American Association of Neurosurgeons, there are approximately 2-3/100,000 population diagnoses of GBM per annum.
Survival with standard of care treatment ranges from approximately 13 months in patient with an unmethylated MGMT gene promotor to approximately
30 months in patients with a highly methylated MGMT gene promotor. Studies show the global GBM treatment market was valued at approximately
$2.46 billion in 2022, with expected growth of 9.7% per annum through 2030.

Following IND approval in
December 2021, we are in the 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.

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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