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`Phase III Trial of Tocosol Paclitaxel Does Not Meet Primary Endpoint
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`FDA I EINS
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`Home
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`Phase III Trial of Tocosol Paclitaxel Does Not Meet
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`Primary Endpoint
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`A Phase III
`in women with metastatic breast cancer did not meet its primary endpoint
`trial of Tocosol Paclitaxel
`of non inferiority on objective response rate when compared with the Taxol control arm Sonus Pharmaceuticals
`reported
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`The objective response rate for Tocosol Paclitaxel was 37 percent versus 45 percent for Taxol The outcome did
`the submission of a new drug application Sonus added
`not support
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`The rates of neutropenia and febrile neutropenia in the Tocosol Paclitaxel arm were significantly higher than the
`Taxol arm which may be related to the higher dose of the drug compared with Taxol The study results also did
`in peripheral neuropathy which was not statistically different between the
`not demonstrate the expected benefit
`two arms the company said
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`Based on these results Sonus and Gennan drugmaker Bayer Schering Pharma said they will close all clinical
`trials of Tocosol Paclitaxel
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`itaxeldoesnotmeetprim aryendpoint
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`11
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`Abraxis EX2006
`Actavis LLC v Abraxis Bioscience LLC
`1PR201701101 1PR201701103 1PR201701104
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