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
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
SYS-CON Events announced today that SoftNet Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. SoftNet Solutions specializes in Enterprise Solutions for Hadoop and Big Data. It offers customers the most open, robust, and value-conscious portfolio of solutions, services, and tools for the shortest route to success with Big Data. The unique differentiator is the ability to architect and ...
You think you know what’s in your data. But do you? Most organizations are now aware of the business intelligence represented by their data. Data science stands to take this to a level you never thought of – literally. The techniques of data science, when used with the capabilities of Big Data technologies, can make connections you had not yet imagined, helping you discover new insights and ask new questions of your data. In his session at @ThingsExpo, Sarbjit Sarkaria, data science team lead ...
A completely new computing platform is on the horizon. They’re called Microservers by some, ARM Servers by others, and sometimes even ARM-based Servers. No matter what you call them, Microservers will have a huge impact on the data center and on server computing in general. Although few people are familiar with Microservers today, their impact will be felt very soon. This is a new category of computing platform that is available today and is predicted to have triple-digit growth rates for some ...
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
In past @ThingsExpo presentations, Joseph di Paolantonio has explored how various Internet of Things (IoT) and data management and analytics (DMA) solution spaces will come together as sensor analytics ecosystems. This year, in his session at @ThingsExpo, Joseph di Paolantonio from DataArchon, will be adding the numerous Transportation areas, from autonomous vehicles to “Uber for containers.” While IoT data in any one area of Transportation will have a huge impact in that area, combining sensor...
SYS-CON Events announced today that Transparent Cloud Computing (T-Cloud) Consortium will exhibit at the 19th International Cloud Expo®, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The Transparent Cloud Computing Consortium (T-Cloud Consortium) will conduct research activities into changes in the computing model as a result of collaboration between "device" and "cloud" and the creation of new value and markets through organic data proces...
So you think you are a DevOps warrior, huh? Put your money (not really, it’s free) where your metrics are and prove it by taking The Ultimate DevOps Geek Quiz Challenge, sponsored by DevOps Summit. Battle through the set of tough questions created by industry thought leaders to earn your bragging rights and win some cool prizes.
Between the mockups and specs produced by analysts, and resulting applications built by developers, there exists a gulf where projects fail, costs spiral, and applications disappoint. Methodologies like Agile attempt to address this with intensified communication, with partial success but many limitations. In his session at @DevOpsSummit at 19th Cloud Expo, Charles Kendrick, CTO at Isomorphic Software, will present a revolutionary model enabled by new technologies. Learn how business and deve...
Enterprises have been using both Big Data and virtualization for years. Until recently, however, most enterprises have not combined the two. Big Data's demands for higher levels of performance, the ability to control quality-of-service (QoS), and the ability to adhere to SLAs have kept it on bare metal, apart from the modern data center cloud. With recent technology innovations, we've seen the advantages of bare metal erode to such a degree that the enhanced flexibility and reduced costs that cl...
SYS-CON Events announced today that Niagara Networks will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Niagara Networks offers the highest port-density systems, and the most complete Next-Generation Network Visibility systems including Network Packet Brokers, Bypass Switches, and Network TAPs.
In his session at Cloud Expo, Robert Cohen, an economist and senior fellow at the Economic Strategy Institute, will provide economic scenarios that describe how the rapid adoption of software-defined everything including cloud services, SDDC and open networking will change GDP, industry growth, productivity and jobs. This session will also include a drill down for several industries such as finance, social media, cloud service providers and pharmaceuticals.
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Intelligent machines are here. Robots, self-driving cars, drones, bots and many IoT devices are becoming smarter with Machine Learning. In her session at @ThingsExpo, Sudha Jamthe, CEO of IoTDisruptions.com, will discuss the next wave of business disruption at the junction of IoT and AI, impacting many industries and set to change our lives, work and world as we know it.
In today's uber-connected, consumer-centric, cloud-enabled, insights-driven, multi-device, global world, the focus of solutions has shifted from the product that is sold to the person who is buying the product or service. Enterprises have rebranded their business around the consumers of their products. The buyer is the person and the focus is not on the offering. The person is connected through multiple devices, wearables, at home, on the road, and in multiple locations, sometimes simultaneously...