BOSTON, April 27, 2016 /PRNewswire/ -- BERG, a biopharmaceutical company uncovering health solutions through a data-driven, biological research approach, today announced that it has initiated a Phase II clinical trial for its drug candidate BPM 31510 in combination with gemcitabine for the potential treatment of pancreatic cancer. The primary objective of the trial is to evaluate safety and efficacy in approximately 25 adult patients with metastatic pancreatic adenocarcinoma. BPM 31510's mechanism reverses the metabolism of a cancer cell and reactivating cell death pathways in mitochondria to behave much like a normal cell.
"We are working diligently to make a difference in the lives of patients with pancreatic cancer and are very pleased to be starting this trial," said Niven R. Narain, BERG co-founder, president and Chief Executive Officer. "Pre-clinical data with combination BPM 31510 and gemcitabine suggest promising activity. We look forward to further exploring its clinical potential in this study."
Narain added, "With use of BERG's Interrogative Biology® platform, we will be applying our precision medicine approach where output from this trial will allow us to match patients to this given combination based on their biological profile."
Phase I results suggest that BPM 31510 is well-tolerated in monotherapy and in combination with a chemotherapy agent. Early anti-tumor activity was seen.
The Phase II open-label, non-randomized clinical trial is initially being conducted at Beth Israel Deaconess Medical Center, Mayo Clinic, the Medical College of Wisconsin and Vita Medical Associates. Additional sites to be added over the next 12 months. The study's principal investigator is Ramesh K. Ramanathan, MD, Director of GI medical oncology at Mayo Clinic in Arizona.
BPM 31510 is being administered as a 144-hour continuous intravenous (IV) infusion along with gemcitabine in advanced pancreatic cancer patients as second line therapy, at a starting dose of 110 mg/kg. Gemcitabine is the current standard treatment option for patients with pancreatic ductal adenocarcinoma, which represents 80 percent of cases.
The study's primary end point is overall response rate (ORR), comprising complete responses (CR) and partial responses (PR). Secondary outcome measures include overall survival (OS), time to progression (TTP), progression-free survival (PFS) as well as an evaluation of the drug combination's safety and change in CA 19-9 levels.
Through BERG's Interrogative Biology Platform® the study will include a true precision medicine approach by collecting blood and tissue samples from patents to create "Molecular Maps" on patients with the disease to assess which patients will be the most effective match for the treatment, and have a higher likelihood of responding.
For more information on this trial, please visit: https://clinicaltrials.gov.
BERG, is a biopharmaceutical company with divisions that include Analytics, Pharma, Biosystems and 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 preclinical assets in CNS diseases and metabolic diseases that complement its late-stage clinical trial activity in cancer and prevention of chemotoxicity. Armed with the 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, please visit www.berghealth.com.
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.