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Sanofi Reports Phase 3 Topline Trial Results Of Iniparib & Otamixaban

Sanofi (SNYNF,SNY) announced topline results of two Phase 3 studies of its investigational compounds iniparib and otamixaban respectively.

The randomized Phase 3 ECLIPSE trial of iniparib in squamous non-small cell lung cancer failed to meet its primary endpoint. During the study, newly diagnosed, metastatic Sq NSCLC patients treated with iniparib plus chemotherapy did not achieve improvement in overall survival compared to patients who received chemotherapy alone.

Topline results of the completed Phase 3 trial of the investigational anticoagulant otamixaban demonstrated that the study failed to meet its primary endpoint of superiority over current therapy. In the TAO study, due to efficacy lower than expected, otamixaban did not show superior benefit/risk to the combination of unfractionated heparin (UFH) +/- eptifibatide (a GP IIb/IIIa inhibitor) in non-ST elevation acute coronary syndrome patients planned for early invasive strategy. The primary endpoint of the Phase 3 TAO trial was the reduction of all-cause mortality or new heart attacks.

As a result, the company would terminate the investigational program with otamixaban, an injectable factor Xa inhibitor.

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