BERG to Conduct Phase Two Trial for Glioblastoma Multiforme

BERG announced the U.S. Federal Drug Administration (FDA) has authorized a phase 2 trial in glioblastoma multiforme (GBM) patients in neo-adjuvant settings using BERG's BPM 31510. Preclinical evidence in an aggressive orthotopic model of GBM suggests that pre-treatment (priming) followed by co-administration of BPM31510 in combination with standard of care, such as radiation and chemotherapy, led to an increase overall survival rates.

"We are honored to make a leap forward in identifying treatments for patients diagnosed with glioblastoma multiforme," said Dr. Niven R. Narain, CEO, President and Co-founder of BERG. "Our work offers hope to patients and holds promise for BERG's BPM 31510, solving a serious unmet need in medicine today."

GBM is the most aggressive, malignant primary brain tumor, averaging 12-18 months of survival time upon diagnosis with only 25% of GBM patients surviving more than one year. Today, GBM-related tumors account for 17% of all tumors of the brain, and tend to occur between the ages of 45 and 70.

This Phase 2 study will be a multi-center trial led by Stanford Medicine and including Yale School of Medicine, Mount Sinai School of Medicine, NY and Cedar-Sinai Medical Center, Los Angeles. The clinical protocol design is based on preclinical results demonstrating complete resolution in greater than 25% of treated cohorts of GBM in an orthotopic model pre-treated with BPM 31510 followed by radiation. In addition, BERG will use its Interrogative Biology® Platform to access patients' samples in this study and perform multi-omic profiling to and build computational patient maps.

Metabolic and mitochondrial dysregulation, a hallmark of cancer, is characterized by cancer's addiction to glycolysis as primary source energy and production of cellular components for unrestricted proliferation. BPM31510 elicits its anti-cancer effect by re-engaging energy production and cell death activation at the level of the mitochondria. BERG in collaboration with researchers at Stanford Medicine have generated evidence that in GBM, BPM31510 elicits its anti-cancer effect by causing a significant increase in mitochondrial-centric oxidative stress specifically in the cancer cells, but not the normal cells. In addition, in preclinical studies in orthotopic model of GBM, pre-treatment with BPM31510 followed by co-comitant administration with radiation therapy was associated with significant long-term survival compared to radiation alone.