Company: BDRX
Filing Date: 2025-05-01
Form Type: DRS
Source: 0001214659-25-006756
Chunk: 37

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-05-01
Form: DRS
Chunk 37
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 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.

| 23 |

: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