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ArQule Announces Initiation of Phase 1 Trial With C-Met Inhibitor; First Patient Enrolled and Successfully Dosed In Trial With ARQ 197

Posted on: Wednesday, 1 February 2006, 18:00 CST

ArQule, Inc. (NASDAQ: ARQL) today 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.

This 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. The primary objectives of the trial are to determine the tolerability, safety and a recommended dosing regimen for Phase 2 trials pending the successful completion of Phase 1. Additionally, the trial will seek to define the pharmacokinetic profile of ARQ 197 and to collect preliminary data on anti-tumor activity.

"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 Dr. Stephen A. Hill, president and chief executive officer of ArQule. "ARQ 197 is the result of ArQule's combined strengths in cancer biology and small molecule chemistry, and we look to transform this innovative scientific approach into added value through clinical development beginning with this trial."

About ARQ 197 and c-Met

ARQ 197 is the lead product from the Company's Cancer Survival Program (CSP), also known as ARQ-650RP. ARQ 197 is designed to block the activity of c-Met, a receptor tyrosine kinase that plays multiple key roles in human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis. The inappropriate expression of c-Met in most cancers and its role in controlling multiple signal transduction pathways involved in tumor growth and metastasis render it a highly compelling therapeutic target for cancer.

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 (IND) application to the U.S. Food and Drug Administration (FDA) for ARQ 197 in late 2005. The Company retains all rights to compounds derived from the ARQ-650RP program, including ARQ 197.

About ArQule

ArQule, Inc. is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company's targeted, broad-spectrum products are designed to affect key biological processes that are central to the development of cancer. ArQule's innovative Activated Checkpoint Therapy(SM) (ACT(SM)) platform is generating products designed to improve the way cancer patients are treated by selectively killing cancer cells and sparing normal cells through restoration and activation of cellular checkpoints that are defective in cancer. ArQule's lead ACT(SM) program, based on E2F elevation, is partnered with Roche. For more information, please visit www.arqule.com.

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, which provides a safe harbor for forward-looking statements made by or on behalf of ArQule. ArQule and its representatives may from time to time make written or oral forward-looking statements, including statements contained in this press release. Generally, the words "believe,""expect,""intend,""estimate,""anticipate,""will" and similar expressions identify forward-looking statements. All statements which address operating performance, events or developments that ArQule expects or anticipates will occur in the future, such as projections about its future results of operations or its financial condition, research, development and commercialization of its products and anticipated trends in its business are forward-looking statements within the meaning of the Reform Act. Actual results may differ materially from those projected in the forward-looking statements or historical performance due to numerous risks and uncertainties that exist in ArQule's operations, development efforts and the business environment, including without limitation: the ACT(SM) platform or other, proprietary platforms may not improve efficacy or reduce toxicity, and compounds resulting from these platforms may not operate as intended; the current and future clinical studies may encounter enrollment difficulties and unexpected toxicity; the commencement of the anticipated clinical trials may be delayed or the trials may never commence; the preclinical efforts associated with the product pipeline may fail or prove disappointing; the animal xenograft preclinical studies may be unpredictive of human response; collaborators may terminate their agreements with ArQule because ArQule may fail to satisfy the collaborators' needs or for other reasons; and, the risks and uncertainties described in ArQule's filings with the Securities and Exchange Commission. The forward-looking statements contained herein represent the judgment of ArQule as of the date of this report. ArQule disclaims any intent or obligation to update any forward-looking statement except to the extent required by law.

Source: Business Wire

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