News Feed Item

Berg Launches First-Ever Stratified Medicine Clinical Trial To Investigate Cancer Metabolism Of Solid Tumors

-- Patients at Cornell, the Palo Alto Medical Foundation, MD Anderson Participate in First Clinical Program to Comprehensively Use Artificial Intelligence --

FRAMINGHAM, Massachusetts, Dec. 9, 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 Biology™ 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.

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

Investor Contact:
Tom Smith
Ogilvy Public Relations
[email protected]

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
DXWorldEXPO LLC announced today that Kevin Jackson joined the faculty of CloudEXPO's "10-Year Anniversary Event" which will take place on November 11-13, 2018 in New York City. Kevin L. Jackson is a globally recognized cloud computing expert and Founder/Author of the award winning "Cloud Musings" blog. Mr. Jackson has also been recognized as a "Top 100 Cybersecurity Influencer and Brand" by Onalytica (2015), a Huffington Post "Top 100 Cloud Computing Experts on Twitter" (2013) and a "Top 50 C...
Cloud-enabled transformation has evolved from cost saving measure to business innovation strategy -- one that combines the cloud with cognitive capabilities to drive market disruption. Learn how you can achieve the insight and agility you need to gain a competitive advantage. Industry-acclaimed CTO and cloud expert, Shankar Kalyana presents. Only the most exceptional IBMers are appointed with the rare distinction of IBM Fellow, the highest technical honor in the company. Shankar has also receive...
Enterprises have taken advantage of IoT to achieve important revenue and cost advantages. What is less apparent is how incumbent enterprises operating at scale have, following success with IoT, built analytic, operations management and software development capabilities - ranging from autonomous vehicles to manageable robotics installations. They have embraced these capabilities as if they were Silicon Valley startups.
DXWorldEXPO LLC announced today that ICOHOLDER named "Media Sponsor" of Miami Blockchain Event by FinTechEXPO. ICOHOLDER give you detailed information and help the community to invest in the trusty projects. Miami Blockchain Event by FinTechEXPO has opened its Call for Papers. The two-day event will present 20 top Blockchain experts. All speaking inquiries which covers the following information can be submitted by email to [email protected] Miami Blockchain Event by FinTechEXPO also offers s...
Poor data quality and analytics drive down business value. In fact, Gartner estimated that the average financial impact of poor data quality on organizations is $9.7 million per year. But bad data is much more than a cost center. By eroding trust in information, analytics and the business decisions based on these, it is a serious impediment to digital transformation.
Daniel Jones is CTO of EngineerBetter, helping enterprises deliver value faster. Previously he was an IT consultant, indie video games developer, head of web development in the finance sector, and an award-winning martial artist. Continuous Delivery makes it possible to exploit findings of cognitive psychology and neuroscience to increase the productivity and happiness of our teams.
As DevOps methodologies expand their reach across the enterprise, organizations face the daunting challenge of adapting related cloud strategies to ensure optimal alignment, from managing complexity to ensuring proper governance. How can culture, automation, legacy apps and even budget be reexamined to enable this ongoing shift within the modern software factory? In her Day 2 Keynote at @DevOpsSummit at 21st Cloud Expo, Aruna Ravichandran, VP, DevOps Solutions Marketing, CA Technologies, was jo...
Predicting the future has never been more challenging - not because of the lack of data but because of the flood of ungoverned and risk laden information. Microsoft states that 2.5 exabytes of data are created every day. Expectations and reliance on data are being pushed to the limits, as demands around hybrid options continue to grow.
The standardization of container runtimes and images has sparked the creation of an almost overwhelming number of new open source projects that build on and otherwise work with these specifications. Of course, there's Kubernetes, which orchestrates and manages collections of containers. It was one of the first and best-known examples of projects that make containers truly useful for production use. However, more recently, the container ecosystem has truly exploded. A service mesh like Istio addr...
As IoT continues to increase momentum, so does the associated risk. Secure Device Lifecycle Management (DLM) is ranked as one of the most important technology areas of IoT. Driving this trend is the realization that secure support for IoT devices provides companies the ability to deliver high-quality, reliable, secure offerings faster, create new revenue streams, and reduce support costs, all while building a competitive advantage in their markets. In this session, we will use customer use cases...
Digital Transformation: Preparing Cloud & IoT Security for the Age of Artificial Intelligence. As automation and artificial intelligence (AI) power solution development and delivery, many businesses need to build backend cloud capabilities. Well-poised organizations, marketing smart devices with AI and BlockChain capabilities prepare to refine compliance and regulatory capabilities in 2018. Volumes of health, financial, technical and privacy data, along with tightening compliance requirements by...
Business professionals no longer wonder if they'll migrate to the cloud; it's now a matter of when. The cloud environment has proved to be a major force in transitioning to an agile business model that enables quick decisions and fast implementation that solidify customer relationships. And when the cloud is combined with the power of cognitive computing, it drives innovation and transformation that achieves astounding competitive advantage.
Evan Kirstel is an internationally recognized thought leader and social media influencer in IoT (#1 in 2017), Cloud, Data Security (2016), Health Tech (#9 in 2017), Digital Health (#6 in 2016), B2B Marketing (#5 in 2015), AI, Smart Home, Digital (2017), IIoT (#1 in 2017) and Telecom/Wireless/5G. His connections are a "Who's Who" in these technologies, He is in the top 10 most mentioned/re-tweeted by CMOs and CIOs (2016) and have been recently named 5th most influential B2B marketeer in the US. H...
DevOpsSummit New York 2018, colocated with CloudEXPO | DXWorldEXPO New York 2018 will be held November 11-13, 2018, in New York City. Digital Transformation (DX) is a major focus with the introduction of DXWorldEXPO within the program. Successful transformation requires a laser focus on being data-driven and on using all the tools available that enable transformation if they plan to survive over the long term. A total of 88% of Fortune 500 companies from a generation ago are now out of bus...