OXiGENE, Inc.
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.
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