Biodexa Reports 12 Month Survival in MAGIC-G1 Study of MTX110 in Recurrent Glioblastoma Patients

Biodexa Pharmaceuticals PLC

Biodexa Reports 12 Month Survival in MAGIC-G1 Study
of MTX110 in Recurrent Glioblastoma Patients

CARDIFF, United Kingdom, February 8, 2024 (GLOBE NEWSWIRE) -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs including Type 1 diabetes and rare/orphan brain cancers, today provided survival updates from its MAGIC-G1 study (NCT05324501) of MTX110 in patients with recurrent glioblastoma (“rGBM”) being conducted at Duke Cancer Institute and Baptist MD Anderson Cancer Center.

In October 2023, Biodexa announced completion of recruitment of Cohort A of an ongoing open-label Phase I dose-escalation study designed to assess the feasibility and safety of intermittent infusions of MTX110 administered by convection enhanced delivery (“CED”) via implanted refillable pump and catheter. Because no drug-related adverse events were observed within the first 30 days from start of treatment, the minimum number of four patients were recruited into Cohort A.

Patient #1 received weekly infusions of 60µM of MTX110 and survived for 12 months from the start of treatment (OS=12).

Patients #2, 3 and 4 each received weekly infusions of 90µM of MTX110, the expected optimum dose, and remain in the study.

GBM universally recurs and once it does median overall survival according to a retrospective analysis of 299 patients reported in the Journal of Neuro-Oncology is 6.5 months¹. Currently, no standard of care is established for rGBM. 

About Glioblastoma Multiforme (GBM)

GBM is the most common and devastating primary malignant brain tumour in adults with incidence of 3 -4 per 100,000 population². Standard of care for treatment of GBM is typically maximal surgical resection followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy. Notwithstanding, the multidisciplinary approach, almost all patients experience tumour progression with nearly universal mortality.

About MTX110

MTX110 is a water-soluble form of panobinostat free base, achieved through complexation with hydroxypropyl-β-cyclodextrin (HPBCD), that enables convection-enhanced delivery (CED) at potentially chemotherapeutic doses directly to the site of the tumour. Panobinostat is a hydroxamic acid and acts as a non-selective histone deacetylase inhibitor (pan-HDAC inhibitor). The currently available oral formulation of panobinostat lactate (Farydak) is not suitable for treatment of brain cancers owing to poor blood-brain barrier penetration and inadequate brain drug concentrations. Based on favourable translational science data, MTX110 is being evaluated clinically as a treatment for recurrent Glioblastoma (NCT05324501), Diffuse Midline Glioma (“DMG”) (NCT04264143) and recurrent medulloblastoma (NCT04315064), and preclinically for treatment of Leptomeningeal Disease. MTX110 is delivered directly into and around the patient's tumour via a catheter system (e.g. CED or fourth ventricle infusions) to bypass the blood-brain barrier. This technique exposes the tumour to very high drug concentrations while simultaneously minimising systemic drug levels and the potential for toxicity and other side effects. Panobinostat has demonstrated high potency against DIPG tumour cells in in vitro and in vivo models, and in a key study it was the most promising of 83 anticancer agents tested in 14 patient-derived DMG cell lines (Grasso et al, 2015. Nature Medicine 21(6), 555-559).