TOKYO, Feb. 27, 2013 /CNW/ - Taiho Pharmaceutical Co., Ltd. announced on
February 27 that it submitted an application on February 26 for
approval of the manufacture and marketing of the novel oral nucleoside
antitumor agent TAS-102 (combination of trifluorothymidine (FTD) and
tipiracil hydrochloride (TPI) ) to the Japanese Ministry of Health,
Labor and Welfare. Taiho Pharmaceutical is seeking approval of TAS-102
for the indication of unresectable, advanced, recurrent colorectal
The application for approval is based on the results of a Phase II
clinical trial (Study 10040030) conducted at 20 facilities throughout
Japan. It was a randomized, double-blind comparative study of TAS-102
and a placebo involving 172 patients with unresectable, advanced,
recurrent colorectal cancer that was refractory to the standard
chemotherapy of at least two or more regimens containing
fluoropyrimidine, irinotecan, and oxaliplatin. The results indicated
that the group administered TAS-102 had improved overall survival rates
(median overall survival: 9.0 months vs. 6.6 months) and a
significantly reduced risk of mortality (HR: 0.56, p=0.0011). The most
frequently reported adverse drug reaction with a CTCAE grade of 3 or
higher was neutropenia. Grade 3 or higher diarrhea, fatigue, nausea,
and other adverse reactions were no more than 10%. Taiho Pharmaceutical
is currently proceeding with a global Phase III clinical trial of
TAS-102 in a similar colorectal cancer population (RECOURSE) with the
ultimate goal of global registration and commercialization of the
Taiho Pharmaceutical believes that TAS-102 will make a significant
contribution to cancer patients and will continue its development
efforts to broaden its use.
TAS-102 is an antitumor agent composed of a combination of
trifluorothymidine (FTD), a nucleoside that incorporates into DNA and
inhibits a variety of genetic 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
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, oxyliplatin,
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 primary outcome measure is overall survival. The principal
researchers are Dr. Atsushi Otsu, director of the Clinical Development
Center of the National Cancer Center Hospital East (Japan), Dr. Robert
J. Mayer of the Dana Farber Cancer Institute (USA), and Dr. Eric Van
Cutsem of the University Hospital Gasthuisberg (Belgium).
About Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (http://www.otsuka.com/en/), 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 a society enriched by smiles." In the field of
oncology in particular, Taiho Pharmaceutical is known as a leading
company in Japan and around the world for developing innovative
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/. The company is headquartered in Tokyo and its President is Masayuki
About Otsuka Holdings Co., Ltd.
The Otsuka Group is a global organization of 156 healthcare companies
with nearly 40,000 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 25 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/.
SOURCE: Taiho Pharmaceutical Co., Ltd.
For further information:
Public Relations Dept.
Taiho Pharmaceutical Co., Ltd.
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