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Results of Phase III study of NK105, a novel macromolecular micelle encapsulating an anticancer drug


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 III clinical study of its in-house 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 in terms of efficacy and safety in patients with metastatic or recurrent breast cancer. The primary endpoint of the study is statistical non-inferiority of PFS. 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 in macromolecular micelles.
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