February 4, 2014
Kyowa Hakko Kirin Announces Commencement of Phase 3 Clinical Study of ARQ 197 (Tivantinib) in Patients with Hepatocellular Carcinoma in Japan
Tokyo, Japan, February 4, 2014--- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced the initiation of a phase 3 clinical study evaluating ARQ 197 (tivantinib) in Japanese patients with c-Met diagnostic-high inoperable hepatocellular carcinoma treated with one prior sorafenib therapy.
This is a randomized, double-blind placebo-controlled study to compare progression-free survival (PFS) of ARQ197 versus placebo. One-hundred-sixty patients is planned to be enrolled to this study.
ARQ 197, an oral agent whose molecular target is c-MET, was discovered by ArQule, Inc. (NASDAQ: ARQL). Kyowa Hakko Kirin signed a license agreement with ArQule for the exclusive rights to the development and sales of ARQ 197 in Japan and some parts of Asia (China, Korea, and Taiwan) on April 27th, 2007.
Kyowa Hakko Kirin has four strategic categories including the oncology area, and is endeavoring to contribute to the treatment of cancer patients through the further development of anticancer agents.
C-Met is receptor tyrosine kinase. When abnormally activated, the c-Met receptor tyrosine kinase plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.
ArQule is a biotechnology company in the United States engaged in the research and development of next-generation, small molecule cancer therapeutics.
About four categories
These are the following four disease areas: Nephrology, Oncology, Immunology&Allergy and Central Nervous System, as presented in Kyowa Hakko Kirin's FY 2013-2015 medium-term business plan.
Study name: JET-HCC
Outline of the Phase 3 Trial of ARQ 197 in Patients with Hepatocellular Carcinoma
|Target Population||C-Met high inoperable hepatocellular carcinoma patients treated with one prior sorafenib therapy|
|Trial Design||Multi-center, randomized double-blind, placebo-controlled trial|
|Dose||One tablet of the trial drug (ARQ 197 120 mg or Placebo) is daily administered to the subjects of each group twice in a day|
|Target Number of Subjects||160|
|Primary Objective||Progression-free survival|
|Trial Duration||Jan. 2014 to Dec. 2016|
Kyowa Hakko Kirin