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Dacogen misses survival endpoint

July 1, 2008 11:38 PM UTC

SuperGen (NASDAQ:SUPG) and Eisai (Tokyo:4523; Osaka:4523) said preliminary data from a Phase III trial to treat myelodysplastic syndrome (MDS) showed that Dacogen decitabine plus best supportive care missed the primary endpoint of improved median survival vs. best supportive care alone. The open-label trial enrolled 233 elderly patients with MDS.

FDA approved the hypomethylating agent in 2006 for MDS based on response rate data. MGI Pharma, a unit of Eisai, holds exclusive worldwide rights to the drug under a deal with SuperGen. MGI licensed ex-North American rights to Johnson & Johnson (NYSE:JNJ). ...