ArQule starts phase 1 trial with c-Met inhibitor for cancer

By Lisa Kerner

Erie, Pa., Feb. 1 - ArQule, Inc. announced the enrollment and successful dosing of the first patient in a phase 1 clinical trial with ARQ 197, a proprietary, orally administered small molecule inhibitor of the c-Met receptor tyrosine kinase.

The open label, dose-escalation trial will include patients with multiple metastatic tumor types who are refractory to available therapy or for whom no standard systemic therapy exists, according to a company news release.

The primary objectives of the trial are to determine the tolerability, safety and a recommended dosing regimen for phase 2 trials. The trial will also seek to define the pharmacokinetic profile of ARQ 197 and to collect preliminary data on anti-tumor activity, the company said.

ARQ 197 is the lead product from ArQule's Cancer Survival Program, designed to block the activity of c-Met, a receptor tyrosine kinase that plays multiple key roles in human cancer, including cancer cell growth. Pre-clinical findings have demonstrated that ARQ 197 inhibits c-Met in a wide range of human tumor cell lines and possesses anti-tumor activity against several types of xenografted human tumors in mice.

ArQule submitted an Investigational New Drug application to the Food and Drug Administration for ARQ 197 in late 2005.

"We are excited about the prospect of a clinical trial with a small molecule that has been shown in pre-clinical studies to selectively and potently inhibit c-Met, one of the most compelling molecular targets for cancer therapy," said Stephen A. Hill, president and chief executive officer of ArQule, in the release.

ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The company is based in Woburn, Mass.

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