Biodexa Pharmaceuticals PLC has announced positive updates from its ongoing MAGIC-1 Phase 1 study of MTX110 in recurrent glioblastoma (rGBM). The data indicates that MTX110 is outperforming historic norms in progression-free survival (PFS) and overall survival (OS) for this aggressive brain cancer.
The Phase 1 study (NCT05324501) is evaluating the feasibility, safety, and efficacy of MTX110 in rGBM patients. Initial results from Cohort A showed that two patients achieved overall survival (OS) of 12 and 13 months, respectively. The remaining two patients in Cohort A are still in follow-up, with one achieving 13 months OS and six months PFS, and the other showing 12 months PFS and 12 months OS to date.
MTX110: A Novel Approach
MTX110 is a proprietary formulation combining water-soluble panobinostat with a convection-enhanced delivery (CED) system. This system delivers the drug directly to the tumor, bypassing the blood-brain barrier. The CED technology allows for up to 100,000 times higher drug concentrations at the tumor site compared to oral dosing, potentially increasing effectiveness and reducing systemic side effects.
Panobinostat, a histone deacetylase inhibitor, affects gene expression in cancer cells, slowing their growth and spread. The combination of targeted delivery and this mechanism offers a dual approach to combating treatment-resistant brain tumors.
Optimism Amidst a Grim Outlook
Glioblastoma is known for its aggressive nature and resistance to conventional treatments. The standard approach includes surgery, radiotherapy, and temozolomide (TMZ) chemotherapy, but recurrence is almost inevitable. Median PFS for recurrent glioblastoma ranges from 1.5 to 6 months, while OS typically falls between 2 to 9 months, according to a study published in Neuro-Oncology. The interim data from the MAGIC-G1 study suggests that MTX110 could provide a new treatment option with real survival benefits and reduced toxicity.
Extending Life Expectancy in Diffuse Midline Glioma
MTX110 has also shown promise in treating Diffuse Midline Glioma (DMG), a rare and aggressive brain cancer primarily affecting children. A Phase 1 study at the University of California, San Francisco (UCSF) reported a median overall survival of 26.1 months with MTX110, compared to the historical median survival of around 10 months for DMG patients. Another Phase 1 trial involving newly diagnosed DMG patients at Columbia University demonstrated improved median overall survival to 16 months after only two infusions per patient.
Potential Breakthrough
Biodexa Pharmaceuticals is positioning MTX110 as a potential game-changer in treating aggressive brain cancers. Early trial results suggest it may offer patients longer survival and better outcomes than standard therapies. Ongoing Phase 1 trials continue to gather crucial data, and if positive trends continue, MTX110 could progress to later-stage clinical trials and potentially become a new standard of care for rGBM and DMG patients.
