ArQule submits application to FDA for cancer drug ARQ 197

By Ted A. Knutson

Washington, Dec. 1 - ArQule, Inc. announced Thursday it has submitted an Investigational New Drug Application to the Food and Drug Administration for ARQ 197, an orally administered, proprietary small molecule c-Met inhibitor to treat cancer.

"Filing of this IND marks the achievement of a major corporate goal for 2005 as scheduled," said Dr. Stephen A. Hill, president and chief executive officer of ArQule, in a news release. "Pending review and clearance by the FDA, we plan to initiate a phase 1 clinical trial with ARQ 197 in early 2006."

ARQ 197 inhibits and kills cancer cells by selectively targeting c-Met, a receptor tyrosine kinase that plays multiple key roles in human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. c-Met is inappropriately expressed in almost all types of human cancer, with a definitively established role in tumor development. Activating mutations of c-Met have been increasingly identified in human cancer.

"c-Met is one of the most compelling molecular targets for cancer therapy," said Dr. Chiang J. Li, chief scientific officer and vice president, head of ArQule Biomedical Institute, in the news release. "In our studies, ARQ 197 selectively and potently inhibits c-Met with broad-spectrum activity against cancer cells, and it has shown potent anti-tumor activity against several types of xenografted human tumors in mice.

"Despite the promise of c-Met as a cancer target, the discovery of a selective c-Met inhibitor has posed a difficult challenge to our industry. The discovery of ARQ 197 and our rapidly expanding pipeline reflect the synergy between our combined strengths in biology and small molecule chemistry."

Woburn, Mass.-based ArQule is a biotechnology company engaged in research and development of next-generation small-molecule cancer therapeutics based on its Activated Checkpoint Therapy platform.

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