Navigation Links
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


'/>"/>
SOURCE Berg
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. Linguamatics Launches Healthcare Product Suite to Turn Unstructured Electronic Health Record Data into Actionable Patient Insights
2. M&G Chemicals Launches Green Revolution in the Polyester Chain
3. TransCelerate BioPharma Inc. Launches Second Year Initiatives, Expands Membership and Achieves Milestones for Original Projects
4. Novogen Launches Joint Venture Aimed At Developing Drugs to Fight Ovarian Cancer
5. Goldstone Scientific Launches, Offering an Easy Shopping Experience for Prizmatix Ultra High Power LED Systems
6. $100 Million Gift Launches Sanford Stem Cell Clinical Center
7. ISPE Launches New Expanded E-Learning Courses
8. Tute Genomics Launches at 2013 ASHG Conference
9. Trade Show Display Co. GLM Displays Launches New “Customer Spotlight” Campaign
10. How Companies Can Provide Extraordinary New B2B Products with Extraordinary Product Launches - A Sales Momentum White Paper
11. QB3 Launches New Biotech Incubator in San Francisco with 24 Companies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/22/2017)... , March 22, 2017  Ascendis Pharma A/S ... innovative TransCon technology to address significant unmet medical ... for the full year ended December 31, 2016. ... for our company as we broadened our pipeline ... integrated rare disease company with an initial focus ...
(Date:3/22/2017)... 22, 2017   iSpecimen ®, the ... Doctors Pathology Service (DPS), a full-service anatomic pathology ... the United States , has joined a program ... Network (DHIN) to make human biospecimens and associated ... novel program, announced in 2015 as a collaboration between ...
(Date:3/22/2017)... 2017   Boston Biomedical , an industry leader ... target cancer stemness pathways, today announced its Board of ... Chief Executive Officer, effective April 24, 2017. ... , M.D., FACP, who has led Boston Biomedical since ... leadership, Boston Biomedical has grown from a "garage startup" ...
(Date:3/22/2017)... Yorba Linda, Ca (PRWEB) , ... March 21, ... ... immunogenicity, and clearance of biologics. To acquire information on the desired increase and/or ... in the biopharmaceutical industry for rapid N-glycosylation profiling of therapeutic antibodies. , ...
Breaking Biology Technology:
(Date:2/26/2017)... , Feb. 25, 2017  Securus Technologies, ... technology solutions for public safety, investigation, corrections and ... Recidivism and Reentry. "Too often, too ... prisons and county jails are trying to tackle ... inmates and friends and family members. While significant steps ...
(Date:2/21/2017)... -- Der weltweite Biobanking-Sektor wird bis zum ... mit mehr als 50 Vertretern aus verschiedenen Branchen wurde aber ... diese Prognose zu realisieren. ... Zu den Schwierigkeiten für ... für die Biobank, die Implementierung Zeit sparender Technologien, ein ...
(Date:2/13/2017)... Feb. 13, 2017 Former 9/11 Commission border ... Committee, Janice Kephart of Identity Strategy Partners, ... Donald Trump,s "Executive Order: Protecting the Nation From ... 2017):  "As President Trump,s ,Travel Ban, Executive ... now essentially banned the travel ban, it is important ...
Breaking Biology News(10 mins):