Phase 3 Pivotal Trial Of TOCOSOL(R) Paclitaxel Does Not Meet Primary Endpoint
Sep 28th 2007Drug InformationBreast Cancer
Sonus Pharmaceuticals, Inc. (NASDAQ:SNUS) announced that its Phase 3 pivotal trial of TOCOSOL(R) Paclitaxel in women with metastatic breast cancer did not meet its primary endpoint of non-inferiority on objective response rate (ORR) when compared to the Taxol(R) control arm. Trial results showed the ORR for TOCOSOL Paclitaxel was 37% versus 45% for Taxol (p value = 0.085). The outcome of this trial does not support the submission of a New Drug Application. [click link for full article]
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