What is Glioblastoma (GBM)?
Glioblastoma (GBM) is 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.
Clinical Trial
BPGbio’s (BERG) 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 BPGbio’s (BERG) 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.
For more information about BPGbio’s (BERG) BPM31510 GBM trial, please click here.