OXiGENE Announces Agreement With FDA on Special Protocol Assessment for a Phase 3 Trial of ZYBRESTAT® in Anaplastic Thyroid Cancer
Published: Sep 18, 2012
SOUTH SAN FRANCISCO, Calif., Sept. 17, 2012 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that it has come to agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for its Phase 3 clinical trial (FACT 2) of ZYBRESTAT for the treatment of anaplastic thyroid cancer (ATC). The FACT 2 study is designed as a randomized, placebo-controlled, double-blinded study of 300 subjects randomized 1:1 to receive carboplatin and paclitaxel plus fosbretabulin versus carboplatin and paclitaxel plus placebo. The primary endpoint of the study will be to compare the median overall survival between the two arms.