OXiGENE (OXGN) Announces Agreement With FDA on Special Protocol Assessment for a Phase 3 Trial of ZYBRESTAT(R) in Anaplastic Thyroid Cancer
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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.
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.
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