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Taiho Pharmaceutical Submits Application for Approval to Manufacture and Market Novel Antitumor Agent TAS-102
Date:2/26/2013

tic functions required for the proliferation of cancer cells, and tipiracil hydrochloride (TPI), an inhibitor of thymidine phosphorylase (which degrades FTD) that maintains an effective blood concentration of FTD. TAS-102 is administered twice daily to achieve a total daily dose of 70mg/square meter for five days followed by two days of rest and then repeated a second time. This is followed by a 14-day rest period to make a 28-day schedule for one course.

About TAS-102 Phase II Clinical Trial
The Phase II clinical trial was conducted with the participation of 172 patients at 20 medical institutions in Japan from August 2009 to April 2010. The target for the study is an area for which there is currently no fully established therapy in Japan -- specifically, patients refractory to standard chemotherapy for metastatic colorectal cancer who have received at least two or more regimens containing fluoropyrimidine, irinotecan, and oxaliplatin. Patients were randomly assigned TAS-102 (114 cases) or a placebo (58 cases). The primary endpoint was overall survival.

About Global Phase III Clinical Trial (RECOURSE)
The Global Phase III Clinical Trial (RECOURSE) is a randomized, double-blind comparative study of TAS-102 versus a placebo. It is a global Phase III clinical trial that is scheduled to enroll a total of 800 patients from Japan, North America, Europe, and Australia. Patient enrollment began in June 2012. The subjects are patients with unresectable, advanced, recurrent colorectal cancer that is refractory to standard chemotherapies (fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab, and EGFR monoclonal antibody in cases of KRAS wild-type tumor). The trial will compare patients randomly assigned to receive TAS-102 or placebo in order to investigate the efficacy and safety of TAS-102. The p
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SOURCE Taiho Pharmaceutical Co., Ltd.
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