Berg Pharma presents at ASCO, poised to lead field in cancer metabolism with Phase II trials of BPM 31510

CAMBRIDGE, Massachusetts, June 12, 2012 /PRNewswire/ -- Berg Pharma, a Boston-based pharmaceutical company presented at the 2012 American Society of Clinical Oncology meeting in Chicago on BPM 31510,  the lead molecule in the Berg's cancer portfolio that targets the metabolism of cancer cells by reversing the Warburg phenotype.  BPM 31510, an endogenous small molecule resident in mitochondria restores oxidative phosphorylation and confers re-capitulation of the BCL-2 protein family potential to induce cell death, a process that cancer evades.  Mechanistic studies show that BPM 31510 does not adversely affect normal tissue but rather optimizes the bioenergetic balance in the tumor microenvironment to "normalize" a cancer cell into behaving much like a healthy cell. 

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Vikas P. Sukhatme, MD PhD, Victor J. Aresty Professor of Medicine at Harvard Medical School and Chief Academic Officer at Beth Israel Deaconess Medical Center commented, "Targeting metabolic pathways that differ between cancer cells and normal cells holds considerable promise for cancer therapy and this study falls squarely in this category. It will be instructive to see if the degree of reversal of the Warburg effect by BPM 31510 correlates with clinical outcomes." 

Results presented at ASCO in the Phase I trial on advanced, refractory, solid tumors revealed that BPM 31510 was well-tolerated with no serious side effects.  The Phase I is on-going as the MTD has not been reached to date however, there has already been very encouraging signs of efficacy with 1 patient showing a near complete response in addition to a few significant partial responses and stable disease profile in various patient cohorts. Linda Vahdat, MD, Professor of Medicine, Head, Solid Tumor Service, and Director of the Breast Cancer Research Program at Weill Cornell Medical School said, "It is terrific to see the implementation of targeting metabolism in treating cancer finally underway. I am cautiously optimistic, based on the preliminary safety and efficacy results of BPM 31510 in the phase I in solid tumors, that we will be able to quickly move this agent into phase II trials in selected cancers."

Berg plans to move into Phase II trials in late 2012 with specific focus on cancers that demonstrate an aggressive/highly metabolic phenotype such as pancreatic, triple-negative breast, and colorectal cancers.  Pre-clinical models presented at the 2012 AACR meeting showed that BPM 31510 has a synergistic effect with various chemotherapy regimens in aggressive cancers.  Niven R. Narain, Co-Founder, President & CTO of Berg Pharma said, "We are excited about moving this agent into Phase II trials with an astute combination strategy based on pre-clinical scientific guidance.  BPM 31510 is showing promising activity in early trials as a monotherapy and we are eager to assess activity in combination with standard of care."

The company also has other clinical programs with a topical form of BPM 31510 for skin cancer and BPM 31543 for supportive care in cancer that prevents hair loss during chemotherapy.  Berg's robust pipeline is fueled by the Interrogative Biology^® platform which has developed therapeutics targets in cancer, endocrinology, and CNS diseases with a focus on mitochondrial metabolism.

About Berg Pharma

Berg Pharma is a Boston based pharmaceutical company and parent company to Berg Biosystems and Berg Diagnostics. Our research focus seeks to understand how alterations in metabolism relate to disease onset.  We have uncovered key insight into metabolic control factors and namely into underlying elements in the Warburg Hypothesis. The company has a deep pipeline of early-stage technologies in CNS diseases and metabolic diseases that complement its late-stage clinical trial activity in cancer and prevention of chemotoxicity. Armed with use of the discovery platform that translates biological output into viable therapeutics and a robust biomarker library, Berg Pharma is poised to realize its pursuit of a healthier tomorrow.