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Preliminary Phase 2 results suggest that BPM31510, an investigational intravenous mitochondrial therapy, may improve outcomes in newly diagnosed glioblastoma (GBM) when added to standard radiation and temozolomide. BPM31510 is designed to deliver very high levels of oxidized CoQ10 into tissues, including the brain, where it may disrupt tumor metabolism, increase oxidative stress, and trigger cancer cell death. The treatment is given together with vitamin K1 to reduce coagulation-related side effects.
In this single-arm Phase 2 trial, BPM31510 was given with standard chemoradiation and temozolomide. Among 39 evaluable patients, median overall survival was 19.3 months. The most encouraging results were seen in the 24 patients with MGMT-unmethylated tumors, where median overall survival reached 29.3 months. It is not yet known whether or why MGMT-unmethylated patients appeared to benefit more, and these results need confirmation in larger randomized studies. Final results from all enrolled patients are expected later this year.