News & Events

Peretinoin (NIK-333) Study Subanalysis Gives Clue To Mechanism of Reduced Recurrence of Hepatocellular Carcinoma (HCC), To Be Presented at American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2011

January 19, 2011

TOKYO, Japan, January 19, 2010

Kowa Company, Ltd. (Headquarters: Nagoya, Japan, President & CEO: Yoshihiro Miwa, “Kowa”) is pleased to announce the results of a subgroup analysis in the phase II/III clinical trial of the HCC recurrence suppression agent peretinoin (generic name; code, NIK-333) developed in Japan, will be presented at the General Poster Session of American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2011 (ASCO-GI 2011) to be held on 20-22 January 2011 in San Francisco, USA. These results reinforce the efficacy of peretinoin in the Phase II/III trial, and give some insight into its mechanism of action.

Presentation Accepted by ASCO-GI 2011 Is As Follows:

Session and
Abstract No.
TitleDate and Venue
General Poster
Session B
Abstract: #165
Clinical Benefit of Peretinoin for
the Suppression of Hepatocellular Carcinoma
(HCC) Recurrence in Patients with
Child-pugh Grade A and Small Tumor
:A Subgroup Analysis in a Phase II/III
Randomized Placebo-controlled trial
Jan. 21, 2011
11:45-18:00*
The Moscone
West Building
Level 1,
West Hall
*Local time

About American Society of Clinical Oncology Gastrointestinal Cancers Symposium 2011
(ASCO-GI 2011)

ConferenceAmerican Society of Clinical Oncology Gastrointestinal Cancers
Symposium 2011
DateJan. 20-22, 2011 (local time)
VenueThe Moscone West Building 800 Howard Street San Francisco,
California 94103

About the Phase II/III Trial

This trial evaluated the ability of peretinoin to suppress the recurrence of HCC in patients who had undergone curative therapy for hepatitis C virus (HCV) positive HCC. These results were also presented at ASCO 2010 held in Chicago, USA, in June 2010 and ILCA 2010 held in Montreal, Canada, in September 2010. The results of a Phase II/III trial showed that peretinoin 600 mg/day given daily for up to 96 weeks reduced the recurrence of HCC after curative therapy in HCV positive patients when compared to placebo.

About Peretinoin

Peretinoin is an oral acyclic retinoid with a vitamin A-like structure, and its main targeting molecule is the retinoid nuclear receptor.

About Liver Cancer and HCC

Liver cancer is the sixth most common cancer in the world, and more than seven
hundred and forty thousand patients are newly diagnosed every year. In Japan, liver
cancer is the third leading cause of death from cancer. About 40,000 patients are newly
diagnosed, and about 30,000 patients die, every year. Primary liver cancer is classified
into HCC and cholangiocellular carcinoma, and about 94% is HCC. HCC is mainly
caused by infections of hepatitis B virus or HCV, and in Japan about 68% of HCC are
caused by HCV. HCV positive HCC is known to have a high recurrence rate after
curative resection, and the recurrence rates are 24%, 76%, 92% within 1, 3, 5 years,
respectively.

About Kowa

Kowa recognizes lifestyle diseases as a R&D priority area and is endeavoring to develop
and explore innovative medicines. In addition, Kowa focuses on three major activities:
drug discovery, innovative formulation discovery, and development of neo generics and
will actively engage in R&D activities to satisfy unmet medical needs.

Contacts:
Kowa Company, Ltd.
Public Relations Department.2, +81-3-3279-7392 (Japanese inquiries only)
info-peretinoin@kowa.co.jp (Japanese and English inquiries)
Fax: +81-3-3279-7250