30.12.2013 13:41:32

Peregrine Pharma Begins SUNRISE Phase III Trial Of Bavituximab - Quick Facts

(RTTNews) - Biopharmaceutical company Peregrine Pharmaceuticals Inc. (PPHM) said it has opened the enrollment of its SUNRISE trial at leading oncology centers in the U.S. SUNRISE is a pivotal Phase III study comparing the firm's investigational immunotherapy bavituximab plus the chemotherapy docetaxel against placebo plus the chemotherapy docetaxel in patients with second-line non-small cell lung cancer or NSCLC. The trial would enroll nearly 600 patients from over 100 medical centers across the globe.

"The design of the SUNRISE trial was based on the compelling Phase II data demonstrating encouraging improvement in overall survival in patients with second-line NSCLC. Furthermore, peer-reviewed published data support that bavituximab and docetaxel share highly compatible mechanisms of action that we believe hold promise for improved patient outcomes,"(1-6) said Joe Shan, MPH, vice president of clinical and regulatory affairs at Peregrine.

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's primary endpoint would be overall survival.

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