ArQule's phase 1 monotherapy data shows promising anticancer activity of ARQ 501

By Lisa Kerner

Erie, Pa., April 4 - ArQule, Inc. said results from its phase 1 monotherapy trial with its lead product, ARQ 501, provide evidence of clinical tolerability and promising anti-tumor activity in cancer patients with advanced solid tumors who had failed prior treatments with chemotherapy.

Data from this trial were presented the 97th Annual Meeting of the American Association for Cancer Research in Washington, D.C.

"The exciting data presented today, combined with the potent and selective anticancer activity of ARQ 501 seen in a broad range of preclinical models, provide a strong rationale for initiating a phase 2 clinical development program," president and chief executive officer Stephen A. Hill said in a news release.

"These encouraging data also begin to define the clinical profile related to ARQ 501's novel mechanism of action."

ArQule said 64 subjects with late-stage cancer received either one or three-hour infusions of ARQ 501 as monotherapy in the dose-escalation trial. Infusions were repeated weekly, every other week or two out of three weeks.

Tumor response was evaluated according to Recist (Response Evaluation Criteria in Solid Tumors) criteria, with tumor regression or disease stabilization observed in many cancer types, including pancreatic cancer, head and neck cancer, ovarian cancer, colorectal cancer and leiomyosarcoma.

Evidence of anti-tumor activity was observed in 18 out of 38 patients, the company said.

ARQ 501, generated from ArQule's Activated Checkpoint Therapy (ACT) platform, activates E2F1-mediated checkpoint pathways, resulting in apoptosis (cell death) in cancer cells.

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

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