FDA grants orphan-drug designation to BERG’s candidate BPM31510

Boston-based Biopharmaceutical company, BERG proclaimed that the U.SS FDA has extended orphan-drug designation to the Company’s leading product candidate BPM31510, for the treatment of pancreatic cancer.

Niven R. Narain, BERG President and Chief Executive Officer commented “We look forward to working closely with the FDA and other regulatory authorities to advance the clinical development of this therapeutic and map out the most effective match for treatment of pancreatic cancer.”

The FDA’s orphan-drug designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Post completion of a Phase 1 clinical trial establishing safety, BERG initiated a Precision Medicine driven Phase 2 clinical trial design for BPM31510-IV alone and in combination with gemcitabine to evaluate the efficacy in patients with advanced pancreatic cancer in the US and Europe.