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

BOSTON, Feb. 15, 2017 — 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.

For more detail regarding this trial, please visit: https://clinicaltrials.gov/ct2/show/NCT03020602