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Taiho Pharmaceutical Announces Start of Global Phase III Clinical Trial in Metastatic Colorectal Cancer with Novel Antitumor Agent TAS-102
Date:5/31/2012

TOKYO, May 31, 2012 /PRNewswire/ -- Taiho Pharmaceutical Co., Ltd. announced on May 31 that a global Phase III clinical trial (RECOURSE) for the novel combination antimetabolite TAS-102 will start in June this year.

RECOURSE is a randomized, double-blind, placebo-controlled Phase III trial that compares TAS-102 with best supportive care (BSC) to investigate the efficacy and safety of TAS-102 when administered to patients with advanced recurrent colorectal cancer that is both unresectable and relapsed/refractory to standard chemotherapies. Standard chemotherapies include fluoropyrimidines, irinotecan, oxaliplatin, bevacizumab and, in the case of patients whose tumor harbors the wild-type KRAS gene, an anti-EGFR monoclonal antibody. The primary endpoint is overall survival. Eight hundred patients around the world will be enrolled into the trial, beginning in Japan in June, followed by North America, Europe and Australia. The principal investigators will be Dr. Atsushi Ohtsu, National Cancer Center Hospital East (Kashiwa/Japan), Dr. Robert J. Mayer, Dana Farber Cancer Institute (Boston/USA), and Dr. Eric Van Cutsem, University Hospital Gasthuisberg (Leuven/Belgium).

Taiho Pharmaceutical is proceeding with the global development of TAS-102 so that this drug can be offered as soon as possible to metastatic colorectal cancer patients who have exhausted standard treatment options.

About TAS-102

TAS-102 combines: FTD (alpha, alpha, alpha-trifluorothymidine), a nucleoside analog which disrupts a variety of DNA functions necessary for the proliferation of cancer cells by being efficiently incorporated into DNA, and 5-chloro-6-(2-iminopyrrolidin-1-yl)-methyl-2, 4(1H, 3H)-pyrimidinedione hydrochloride (TPI), which maintains an effective blood concentration of FTD by inhibiting thymidine phosphorylase which is the primary enzyme involved in the degradation of FTD.

See the July 22, 2011 News Release for details on the Phase II clinical tria
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SOURCE Taiho Pharmaceutical Co., Ltd.
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