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Peregrine Pharmaceuticals Inc receives FDA fast track designation for its immunotherapy bavituximab

Monday, 6 Jan 2014 07:30am EST 

Peregrine Pharmaceuticals Inc:Says has received fast track designation by the U.S. Food and Drug Administration (FDA) for its investigational immunotherapy bavituximab for the potential treatment of second-line non-small cell lung cancer (NSCLC).Says the company initiated SUNRISE, a pivotal Phase III clinical trial comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in this indication.Says SUNRISE is a Phase III, global, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and efficacy of bavituximab plus docetaxel in patients with second-line non-small cell lung cancer.Says trial is evaluating bavituximab plus docetaxel versus docetaxel plus placebo in about 600 patients at more than 100 clinical sites worldwide.Says patients with Stage IIIb/IV non-squamous, NSCLC who have progressed after standard front-line treatment are eligible for enrollment.Says patients will be randomized into 1 of 2 treatment arms. 

Company Quote

28 Aug 2015