ArQule enrolls, doses first patient in phase 2 trial of ARQ 501 for pancreatic cancer

By Lisa Kerner

Charlotte, N.C., June 20 - ArQule, Inc. enrolled and dosed the first patient in its phase 2 clinical trial of ARQ 501 in combination with gemcitabine to treat pancreatic cancer.

Up to 70 patients with treatment-naive, unresectable pancreatic adenocarcinoma are expected to be enrolled in the single-arm, open-label trial at multiple U.S. sites and abroad.

Patients will receive separate infusions of 800 mg/m2 of gemcitabine and 400 mg/m2 of ARQ 501 once weekly in four-week cycles.

The primary endpoint of the study is the Objective Response Rate as measured by Recist (Response Evaluation Criteria in Solid Tumors) criteria, according to ArQule.

"With the dosing of the first patient in this combination therapy trial, we now are actively enrolling patients in two phase 2 studies with ARQ 501," president and chief executive officer Stephen A. Hill said in a company news release.

ArQule is also selecting sites for a monotherapy trial with ARQ 501 in head and neck cancer as well as planning a combination study with ARQ 501 and a taxane in ovarian cancer to begin later this year, officials said.

The company's lead product, ARQ 501, is generated from its Activated Checkpoint Therapy (ACT) platform being developed with Roche. ACT compounds target cancer cells through activation of checkpoint pathways, leading to cell death.

Based in Woburn, Mass., ArQule researches and develops small-molecule cancer therapeutics.

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