ArQule and Daiichi Sankyo announce the recruitment of the first patient in the study global phase III of tivantinib in hepatocellular carcinoma.

– the research will involve 300 patients of approximately 120 universities from various countries around the world, including Spain

Madrid, February 2013- Daiichi SankyoCo. Ltd. and ArQule, Inc. have announced the recruitment of the first patient in the pivotal study phase III METIV HCC (MET-high patients with tivantinib in HCC; i.e., patients with high levels of expression of MET treated with tivantinib and hepatocellular carcinoma). The study analyzes the role of tivantinib, a selective inhibitor of MET, a receptor tyrosine kinase, in the treatment of patients diagnosed with carcinoma hepatocellular (HCC) who have previously received one or two systemic therapies against his disease.

METIV HCC is a randomized, double-blind and placebo controlled, in which patients with unresectable HCC associated with high levels of expression of MET, previously treated, will receive treatment with tivantinib or placebo. The main objective is to analyze the overall in this type of patient survival, while the secondary is to evaluate disease progression-free survival time. The study will involve 300 patients of approximately 120 universities from various countries around the world, including Spain. more information about the study in the following link.

We are pleased to announce the launch of this important phase III study that will allow us to advance the understanding of the potential role of tivantinib in the treatment of hepatocellular carcinoma ”, says Glenn Gormley, responsible for global research and development of Daiichi Sankyo, which adds: hope this study confirm the positive results of phase II in the time to progression of the disease and survival overall, observed in those patients whose tumors had high levels of expression of MET ”.

Hepatocellular carcinoma is a devastating disease and there is a great need to develop new therapies that will help to lengthen the life expectancy of people who suffer from it ”, explains at the same time Paolo Pucci, Chief Executive Officer of ArQule.

In October 2012, has reached an agreement with the US FDA for the development of a special evaluation of this phase III study protocol (SPA by its English acronym). SPA is a procedure by which the FDA provides official evaluation and recommendations in writing on the design and size of the protocols proposed with the intention of that part of the application for approval of a new drug. Final marketing approval depends on the results of this study.

On carcinoma hepatocellular (HCC)

Worldwide, liver cancer is the sixth most common cancer (749,000 new cases per year) type, the third cause of mortality from cancer (692.000 cases) and accounts for seven percent of all tumors. HCC represents more than 90 percent of primary cancers of liver (1).

Chronic infection with hepatitis B and C viruses are the main factors of HCC and the risk is even higher when coexist both infections (2). Cirrhosis is also a risk factor for the development of HCC.

About tivantinib and MET

Tivantinib is a selective inhibitor of MET, a receptor tyrosine kinase, oral administration. In the cells of healthy adults, the presence of adequate levels of MET promotes normal cell function. On the other hand, in cancer cells the MET is enabled by a continuous and inappropriate for reasons that are unknown. To activate abnormally, MET affects many processes of cancer, as the growth of cancer cells, angiogenesis, invasion or metastasis.

On ArQule and Daiichi Sankyo

In December 2008, ArQule and Daiichi Sankyo signed an agreement for the development and joint marketing of tivantinib (ARQ 147) in the United States.USA, Europe, Latin America and other parts of the world, with the exception of Japan, China (including Hong Kong), Korea of the South and Taiwan.

On Daiichi Sankyo

The Daiichi Sankyo group is dedicated to the research and supply of innovative medicines, both in mature markets and emerging, with the aim to cope with various medical needs not yet covered. The company was created in 2005 through the merger of two Japanese companies of great tradition and Daiichi Sankyo. With net sales close to 8.5 billion euros, Daiichi Sankyo is one of the 20 major pharmaceutical companies in the world. In addition to a consolidated portfolio of drugs against hypertension, Hyperlipidemia, and bacterial infections, Daiichi Sankyo investigates new therapies in the cardiovascular area and in oncology. The Daiichi Sankyo group has established the hybrid business model ” that combines innovative and generic drugs with the aim of reaching the largest possible number of patients.

The company’s world headquarters is located in Tokyo. The European headquarters of Daiichi Sankyo is situated in Munich and has branches in 12 European countries as well as a world manufacturing located in Pfaffenhofen (Germany) plant.

Referencia:

(1) EASL – EORTC Clinical Practice Guidelines: Management of hepatocellular carcinoma. Journal of Hepatology. 2012; 56: 908-943

(2) Chiaramonte M, Stroffolini T, Vian, et al.: Rate of incidence of hepatocellular carcinoma in patients with viral compensated cirrhosis. Cancer 85 (10): 2132-37, 1999.