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Under the guidelines of the EMEA, medicinal products are designated as orphan drugs when they are used to treat illnesses affecting small numbers of patients, such as soft tissue sarcoma. Such designation provides for incentives for investment in the research and development of such drugs, including exclusive distribution rights throughout the European Union for ten years, during which period no other product with the same active ingredient would be authorized for use for the same therapeutic application.
ArQule said that it is conducting a Phase 2 clinical trial with ARQ 197 in a sub-group of soft tissue sarcoma known as MiT (Microphthalmia Transcription Factor)-associated tumors. The designation of ARQ 197 as an orphan medical product in soft tissue sarcoma, combined with the evaluation of clinical data from this trial expected to be available in early 2010, will inform the decisions related to the advancement of the program.
About ARQ 197 and c-MET
In addition to soft tissue sarcoma, ARQ 197 is currently being evaluated in Phase 2 clinical trials in non-small cell lung cancer, pancreatic cancer and hepatocellular carcinoma.
ARQ 197 is a selective inhibitor of c-MET, a receptor tyrosine kinase. When abnormally activated, c-MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. Pre-clinical data have demonstrated that ARQ 197 inhibits c-MET activation in a wide range of human tumor cell lines and shows anti-tumor activity against several human tumor xenografts. In clinical studies to date, treatment with ARQ 197 has been well tolerated and has resulted in tumor responses and prolonged stable disease across broad ranges of tumors and doses.
According to Company officials, on December 19, 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialization agreement to co-develop ARQ 197 in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan, where Kyowa Hakko Kirin Co. has exclusive rights for development and commercialization.
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics.
((Comments on this story may be sent to health@closeupmedia.com))
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