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`Results of Phase Ill study of N K105 a novel macromolecular micelle encapsulating an anticancer drug FirstWord Pharma Print
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`Results of Phase III study of NK105 a novel
`macromolecular micelle encapsulating an anticancer
`drug
`
`Created 07122016 337
`Tokyo Japan July 05 2016 Nippon Kayaku Co Ltd Head Office Tokyo President Masanobu Suzuki
`hereinafter referred to as Nippon Kayaku announced
`that in a phase 111 clinical study of its inhouse
`developed polymeric micelle anti cancer drug NK105 in patients with metastatic or recurrent breast cancer the
`primary endpoint of the study progression free survival PFS did not meet the prespecified statistical criteria
`
`The study is a randomized multinational study comparing weekly administration of NK105 versus Paclitaxel
`terms of efficacy and safety in patients with metastatic or recurrent breast cancer
`
`in
`
`The primary endpoint of the study is statistical non inferiority of PF S Detailed efficacy and safety analyses
`from this study are expected to be presented at an upcoming scientific congress Future plans for the
`development of NK105 will be further examined
`
`About NK105
`NK105 is a novel DDS Drug Delivery System formulation encapsulating active ingredient paclitaxel
`macromolecular micelles
`
`in
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`Actavis LLC v Abraxis Bioscience LLC
`1PR201701101 1PR201701103 1PR201701104
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