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Glioblastoma Multiforme (GBM)

Glioblastoma (GBM), an aggressive type of malignant primary brain tumor with very poor survival as less than 10% of patients live more than five years after diagnosis and nearly 100% of patients experience disease relapse after initial treatment. Standard-of-care treatment includes surgical resection, radiation therapy (RT), and/or chemotherapy (e.g., temozolomide; TMZ). However, acquired chemo-resistance is common, and response rates in recurrent gliomas to a second cycle of TMZ chemotherapy are less than 10%. Recent advancements have identified several mitochondrial processes including altered protein expression, metabolic programming, and mitochondrial-dependent regulation of apoptotic pathways as well as a high glycolytic phenotype (Warburg effect) is critical to progression of this disease.

BPM 31510 is an ubidecarenone (ubiquinone; Coenzyme Q10) containing nanodispersion with anti-cancer effects mediated by molecular mechanisms in mitochondria that trigger the process of regulated cell death. BPM 31510 was found to be active in human GBM cell models in vitro and in an orthotopic rat glioma model in vivo. Using an orthotopic glioblastoma animal model, treatment with BPM 31510 resulted in significantly prolonged survival, with 29% of animals living up to 50 days while all non-treated animals died within 16 days (ref). Furthermore, in vitro treatment of glioma cells and non-tumor cell co-cultures with BPM 31510 differentially and rapidly raised intramitochondrial superoxide levels in glioma cells relative to non-tumor cells to induce cell death. These findings suggest a therapeutic potential for BPM 31510 in the highly aggressive glioma cancer cells.

BPM31510IV-11 is an ongoing Phase II Study with Vitamin K1 in Subjects with Newly Diagnosed Glioblastoma (GBM) and is currently enrolling patients. This single arm, non-randomized, multi-center open-label Phase 2 trial will assess the effects of adding BPM 31510- IV onto a conventional treatment framework of radiation and concurrent temozolomide treatment. The primary objective of this multi-site US trial is to assess the safety and efficacy of BPM 31510-IV and Vitamin K1 administered neoadjuvantly and concurrently with standard RT and TMZ and primary end point is progression free survival (PFS) at 6 months.

Details to the study can be found here.