The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of necuparanib as a first-line treatment in combination with paclitaxel and gemcitabine in patients with metastatic pancreatic cancer. Necuparanib is a novel oncology drug candidate engineered from unfractionated heparin to have significantly reduced anticoagulant activity while preserving relevant antitumor properties associated with heparins.
The FDA’s Fast Track Drug Development Program is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Clinical Trial Underway
In October 2014, Momenta Pharmaceuticals completed the Part A dose-escalation component of the phase I/II clinical trial evaluating necuparanib in combination with paclitaxel and gemcitabine in patients with advanced metastatic pancreatic cancer, and reported positive top-line data. Part B of the phase I/II trial, currently underway, is a randomized, controlled, proof-of-concept study to evaluate the antitumor activity of necuparanib in combination with paclitaxel plus gemcitabine vs paclitaxel plus gemcitabine alone. The company expects data from Part B to be available in the first half of 2017.
Necuparanib received Orphan Drug designation from the FDA for the treatment of pancreatic cancer in June 2014. ■