Peregrine Gets Fast Track Status for NSCLC Biologic

Peregrine Pharmaceuticals has received Fast Track designation from the FDA for immunotherapy bavituximab for the potential treatment of second-line non-small cell lung cancer (NSCLC). The company recently initiated SUNRISE, a pivotal Phase III trial comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in this indication.

Fast Track status is 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. It enables a sponsor to have more frequent and timely communication and meetings with the FDA regarding product development plans and may also result in eligibility for priority review of NDAs or BLAs. Fast Track designation does not apply to a product alone but a combination of a product and specific indication.

SUNRISE is a Phase III, global, randomized, double-blind, placebo-controlled trial evaluating bavituximab plus docetaxel versus docetaxel plus placebo in approximately 600 patients at more than 100 clinical sites worldwide. Patients with Stage IIIb/IV non-squamous NSCLC who have progressed after standard front-line treatment are eligible for enrollment. Patients will be randomized into one of two treatment arms. All patients will receive as many as six 21-day cycles of docetaxel (75 mg/m2) plus weekly infusions of either bavituximab (3mg/kg) or placebo until progression or toxicity. The primary endpoint of the trial will be overall survival.

Bavituximab is a first-in-class phosphatidylserine (PS)-targeting monoclonal antibody. It is a highly immunosuppressive molecule usually located inside the membrane of healthy cells, but “flips” and becomes exposed on the outside of cells that line tumor blood vessels, creating a specific target for anti-cancer treatments. PS-targeting antibodies target and bind to PS and block this immunosuppressive signal, thereby enabling the immune system to recognize and fight the tumor.