Peregrine Pharma Gets FDA Fast Track Designation For Immunotherapy Bavituximab

(RTTNews) - Peregrine Pharmaceuticals, Inc. (PPHM) said it has received Fast Track designation by the U.S. Food and Drug Administration or FDA for its lead investigational immunotherapy bavituximab for the potential treatment of second-line non-small cell lung cancer or NSCLC. The firm recently began a pivotal Phase III trial, SUNRISE, comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in this indication.

Robert Garnick, Ph.D., head of regulatory affairs at Peregrine, stated: "We are very pleased that the FDA has recognized the potential of this novel therapy as a treatment for this serious and devastating type of cancer and look forward to working closely with them to ensure the most efficient review process."

The Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

SUNRISE ("Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study") is a Phase III, global, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability and efficacy of bavituximab plus docetaxel in patients with second-line NSCLC. The trial is evaluating bavituximab plus docetaxel versus docetaxel plus placebo in nearly 600 patients at over 100 clinical sites worldwide.