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

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• Publié par: asianet-kyodo-news-agency
• Nombre de lectures: 13
• Langue: English

Extrait

Taiho Pharmaceutical Announces Start of

Global Phase III Clinical Trial in Metastatic

Colorectal Cancer with Novel Antitumor Agent

TAS-102

PR Newswire

TOKYO, May 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 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: [phone]

e-mail: [e-mail]

* For inquiries, please contact us by e-mail.