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BERG Initiates Phase I/II Monotherapy Trial of BPM 31510-IV in Patients with Glioblastoma Multiforme (GBM)

BOSTON, Feb. 15, 2017 /PRNewswire/ -- BERG LLC, a biopharmaceutical company uncovering health solutions through a data-driven, biological research approach, today announced that it has initiated a Phase I/II monotherapy clinical trial for its drug candidate BPM 31510-IV for the potential treatment of glioblastoma multiforme. The compound was guided in development by BERG's unique AI-based Interrogative Biology® platform that combines patient biology and artificial intelligence-based analytics to better understand the differences between healthy and disease environments.

"Glioblastoma is one of the deadliest and most insidious forms of cancer and we are working to make a much-needed difference in the lives of patients with glioblastoma to improve survival, and quality of life," said Niven R. Narain, BERG Co-Founder, President and Chief Executive Officer of BERG. "The initiation of this Phase I/II trial marks the continued advancement of BPM 31510-IV, and further demonstrates BERG's Interrogative Biology® platform."

Currently, there are minimal treatment options for patients with GBM and with the five-year relative survival rate at only 5.1 percent new treatment strategies are urgently needed (National Brain Tumor Society). Standard of care treatment options are limited, often resulting in recurrence of the disease after multiple lines of therapy. As such, patients with GBM are in critical need of an effective and tolerable treatment option to increase rates of survival and quality of life.

The Phase I/II open-label, non-randomized clinical trial is designed to evaluate the safety and tolerability of BPM 31510-IV in subjects with glioblastoma multiforme that has recurred on a bevacizumab-containing regimen. Secondary outcome measures are to characterize the pharmacokinetics and pharmacodynamics of BPM31510-IV in subjects with glioblastoma multiforme that has recurred on a bevacizumab-containing regimen. The trial is initially being conducted at the Stanford University School of Medicine by principal investigators Dr. Seema Nagpal and Dr. Lawrence Recht.

BPM 31510-IV was previously demonstrated to be safe in patients in a Phase I clinical trial in solid tumors. Additionally, preclinical studies conducted by BERG, the Stanford University School of Medicine and the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine suggest the therapeutic efficacy of BPM 31510-IV as single agent in GBM. These studies also demonstrate the possible beneficial effect of BPM 31510-IV in combination with temozolamide (TMZ), the existing standard of care for GBM. In pre-clinical models, pretreatment with BPM 31510-IV followed by TMZ showed reduced cancer cell proliferation when compared to monotherapy.

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About BPM 31510-IV

BPM 31510-IV has the potential to slow or stop cancer cell growth by reversing the compromised metabolism of cancer cells, which is hypothesized to be a fundamental driver of many different types of cancer.   BERG has also initiated a Phase II clinical trial for BPM 31510-IV in advanced pancreatic cancer in combination with a common cancer drug, among other ongoing and planned trials for BPM31510-IV in various oncological indications.

About Glioblastoma Multiforme

According to the National Brain Tumor Society, glioblastoma multiforme is the most common and deadliest of malignant primary brain tumors in adults. GBM accounts for 45% of all brain cancers, with nearly 11,000 men, women, and children diagnosed each year.

About BERG 
BERG is a clinical-stage company disrupting and redefining the approach to drug discovery, research and development through its Interrogative Biology® platform.  Its platform identifies therapies and biomarkers by applying algorithm and probability based artificial intelligence to analyze large numbers of patients' genotypic, phenotypic and other characteristics.  BERG believes this allows the company to better understand patients' disease profiles and consequently to reveal molecular signatures that guide and accelerate product candidate selection and development. By identifying biomarkers and patient characteristics that are unique to disease states, BERG is able to identify novel therapeutic product candidates and develop companion diagnostics to enhance specificity in its drug development process. BERG has leveraged its Interrogative Biology® platform to develop a robust pipeline of therapeutic product candidates and diagnostics in cancer, diabetes and neurology. 

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