Taiho Pharmaceutical Announces Start of Global Phase III Clinical Trial in Metastatic Colorectal Cancer with Novel Antitumor Agent TAS-102

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 trial.
In Japanese: http://www.taiho.co.jp/corporation/news/2011/20110722.html
In English: http://www.taiho.co.jp/english/news/20110722.html

About Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd., is an R&D-driven specialty pharma focusing on the three fields of oncology, allergies and immunology, and urology. Its corporate philosophy takes the form of a pledge: "We strive to improve human health and contribute to the enrichment of society." In the field of oncology in particular, Taiho Pharmaceutical is known as a leading company in Japan and around the world for developing evidence-based medicines for the treatment of cancer. In areas other than oncology as well, the company creates quality products that effectively treat medical conditions and can help improve people's quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer over-the-counter medicinal products that support people's efforts to lead fulfilling and rewarding lives. The company is headquartered in Tokyo and its President is Masayuki Kobayashi. For more information about Taiho Pharmaceutical, please visit http://www.taiho.co.jp/english/

About Otsuka Holdings Co., Ltd.
The Otsuka Group is a diversified healthcare group operating globally under the corporate philosophy "Otsuka-people creating new products for better health worldwide". The Otsuka Group has business operations in 24 countries and regions around the world, and its consolidated sales for FY2011 are 1,154.6 billion Japanese yen. For more information, please visit the company's website at www.otsuka.com/en/.

Contact:
Mitsutoshi Utatsu
Public Relations Dept.
Taiho Pharmaceutical Co., Ltd.
Tel: +81-3-3293-2878
e-mail: th-102a@taiho.co.jp
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