Taiho Pharmaceutical Announces Results of Randomized Phase II Clinical Trial with Novel Antitumor Agent TAS-102

TOKYO, July 22, 2011 /PRNewswire/ --

- Positive Results of Overall Survival in Patients with Colorectal Cancer Refractory to Standard Chemotherapy -

Taiho Pharmaceutical Co., Ltd. (HQ: Tokyo, President: Toru Usami) announced on July 22 the results of a randomized, Phase II clinical trial for the novel oral nucleoside antitumor agent TAS-102 under development by the company for metastatic colorectal cancer, at the 9th Annual Meeting of the Japanese Society of Medical Oncology held in Yokohama. (Abstract no. 10428)

The trial was a randomized, double-blind, placebo-controlled study with a primary outcome measure of overall survival involving 172 patients with refractory metastatic colorectal cancer who had received standard chemotherapy at least two or more regimens containing a fluoropyrimidine, irinotecan, and oxaliplatin. The results indicated that the TAS-102 significantly improved overall survival compared with the placebo (overall survival median: 9.0 months vs. 6.6 months) and significantly reduced the risk of mortality (HR=0.56, p=0.0011). Also, no instances of treatment-related mortality were reported. The most frequently reported adverse drug reaction with a CTCAE grade 3 or higher was neutropenia. Grade 3 or higher diarrhea, fatigue, nausea, and other adverse reactions were no more than 10%.

In light of these results, Taiho Pharmaceutical will proceed with global development of TAS-102 so that this drug can be offered as soon as possible to metastatic colorectal cancer patients who have exhausted proven treatment options and there remains a high unmet medical need.

About TAS-102:

TAS-102 is a novel oral nucleoside antitumor agent with a novel mechanism of action, composed of a mixture of Trifluorothymidine (FTD), which demonstrates antitumor effects through incorporation into DNA, and 5-chloro-6-(2-iminopyrrolidin-1-yl)-methyl-2,4(1H,3H)-pyrimidinedione hydrochloride (TPI), which inhibits the degradation of FTD. Phase I trials began in Japan in 2005, and the drug continues to be developed as a treatment for colorectal cancer refractory to standard chemotherapy and for which there is presently no established therapy.

About TAS-102 Phase II clinical trial:

The Phase II 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 -- specifically, patients refractory to standard chemotherapy for metastatic colorectal cancer who have received at least two or more regimens containing a fluoropyrimidine, irinotecan, and oxaliplatin. Patients were randomly assigned to the TAS-102 (114 cases) or a placebo (58 cases). The primary endpoint was overall survival. TAS-102 and placebo were administered at dose of 70mg/m2/day twice daily for five days followed by two days rest and repeated twice. This was followed by a 14-day rest period to make a 28-day schedule for one course. In both cohorts, the 28-day cycle was repeated until the established criteria for termination were met.

About Taiho Pharmaceutical:

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. For more information about Taiho Pharmaceutical, please visit http://www.taiho.co.jp/english/

About Otsuka Holdings Co., Ltd.:

The Otsuka Group is a global organization of 145 healthcare companies with nearly 39,000 employees. Otsuka Holdings Co., Ltd., is the Group's holding company. The main operating companies are Otsuka Pharmaceutical Co., Ltd.; Otsuka Pharmaceutical Factory, Inc.; Taiho Pharmaceutical Co., Ltd.; Otsuka Warehouse Co., Ltd.; and Otsuka Chemical Co., Ltd. The Group operates in 23 countries and regions, conducting diversified businesses in four segments, all connected by a focus on health: pharmaceuticals, nutraceuticals, consumer products, and other product areas. The Group's corporate philosophy of "Otsuka-people creating new products for better health worldwide" is supported by the corporate ethic of "JISSHO (Proof through Execution) and SOZOSEI (Creativity)." The Otsuka Group thus seeks to foster a culture and vitality appropriate to an enterprise involved with human health and to create innovative products that contribute to the health and wellness of people worldwide. For more information, please visit the company's website at http://www.otsuka.com/en/

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