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Berg Launches First-Ever Stratified Medicine Clinical Trial To Investigate Cancer Metabolism Of Solid Tumors
Date:11/21/2013

FRAMINGHAM, Mass., Nov. 21, 2013 /PRNewswire/ -- Berg, a biopharmaceutical company committed to uncovering health solutions through a data-driven, biological research approach, today announced  a first-of-its-kind Phase Ib clinical trial with Weill Cornell Medical College, Palo Alto Medical Foundation, and MD Anderson Cancer Center to study its investigational compound, BPM 31510 (IV Continuous Infusion), as a new cancer therapy for solid tumors.

"Unlike other clinical trials, this is the first program to focus on the metabolism, or processes, of cancer rather than a specific mutation or target," said Niven R. Narain, Co-Founder, President and CTO of Berg. "By using big data analytics, we're also able to identify the right type of patients who will respond to the BPM 31510 treatment. Stratifying patients by phenotype is the future of medicine and we want to boldly develop a cancer treatment using this approach"

Peter Yu, MD, Director of Cancer Research at Palo Alto Medical Foundation and incoming president of The American Society of Clinical Oncology (ASCO), will serve as a primary investigator on this trial together with Ralph Zinner, MD at MD Anderson and lead PI, Manish Shah, MD at Weill Cornell Medical College, which is expected to enroll between 300 - 400 oncology patients affected by solid tumors, including those with highly aggressive cancers like pancreatic, triple-negative breast, liver or brain.

BPM 31510 targets the cellular machinery that governs metabolism of cancer cells to alter those cells to behave like normal, healthy cells. The treatment is the first in Berg's pipeline endogenously occurring candidates discovered and developed by the Berg Interrogative BiologyTM platform, an artificial intelligence-based system that uses network biology methodologies to study biological systems.

Through Berg's proprietary Interrogative Biology™ Drug Discovery Platform, this clinical program will establish each patient's molecular and metabolic fingerprint by analyzing multi-omic tissue samples (blood, urine, bone marrow, etc) in real time. This step will allow trial investigators to understand how patients' cells are responding to the treatment to assess the unique characteristics in patients who are responding to the therapy or combinations with BPM 31510.  One very interesting arm of the trial will also assess the effect of "mitochondrial priming" where BPM 31510 will be given for 1 cycle followed by chemotherapy to assess for increased efficacy and potential reduction in chemo-induced side effects.

"It is both a privilege and honor to work with Berg - a forward thinking broad reaching company that is interested in truly moving the bar in medicine in a comprehensive and revolutionary way," said Dr. Manish A. Shah, Associate Professor of Medicine at the Weill Cornell Medical College of Cornell University.  "The goal of this comprehensive and unprecedented evaluation of clinical data, molecular profiles, and patient characteristics - a virtual clinical 'big data' evaluation - is to develop safer, more effective drugs in half the time. Drug development is an arduous process, but with Berg as a partner, it feels like we are on the fast track."

More information about the clinical trials evaluating BPM 31510 also can be found at www.ClinicalTrials.gov.

About BPM 31510
Berg's lead molecular candidate, BPM 31510, is a proprietary formulation of ubidecarenone, an endogenous small molecule responsible for generating cell energy. Preclinical trials indicate that BPM 31510 normalizes the BCL2 protein, which is a key feature in the regulation of cell death and is over-expressed in 60-70% of tumors.

BPM 31510 is being investigated in clinical trials as both a monotherapy and in combination with chemotherapies like gemcitabine, 5FU and docetaxel for its potential to treat numerous cancers, including squamous cell carcinoma and solid tumors. 

About the Berg Interrogative Biology™ Platform
Berg's application of machine-learning (Artificial Intelligence) in biology and medicine allows for a combination of systems biology and systems engineering leading to well defined answers on human health. The Berg Interrogative Biology™ platform integrates molecular data directly from a patient with clinical and demographic information to learn predictive patterns. The platform has the potential to provide the physician with actionable information to recommend efficient and safe treatment pathways, insurance companies with health economics analyses to develop more relevant formulary and governments with a data ecosystem for financial modeling of healthcare needs of the population.

Using the Interrogative Biology platform, the company has successfully harnessed the ability of its lead oncology candidate, BPM 31510, in development with gemcitabine, to create an anti-cancer effect. Phase 1 and 2 clinical trials of a topical formulation of BPM 31510 for the treatment of skin cancers have completed, as has a Phase 1 dose escalation clinical trial of an intravenous formulation of BPM 31510 for the treatment of solid tumors.

About Berg                           
Berg, the namesake of Carl Berg, is a biopharmaceutical company and parent company to Berg Pharma, 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 is poised to realize its pursuit of a healthier tomorrow. For additional information, visit http://www.bergpharma.com/.

Media Contact:
Alisha Tischler
Ogilvy Public Relations
212-880-5218
alisha.tischler@ogilvy.com

Investor Contact:
Tom Smith
Ogilvy Public Relations
212-880-5269
tom.smith@ogilvy.com


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