ARQULE INITIATES CLINICAL DEVELOPMENT OF ARQ 501

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ArQule has announced the enrollment and successful dosing of the first patient in a Phase II clinical trial of ARQ 501 in combination with gemcitabine to treat pancreatic cancer.

The company expects to enroll approximately 60 to 70 patients with treatment-naive, unresectable pancreatic adenocarcinoma in this single-arm, open-label trial, which will be conducted at multiple investigator sites in the U.S. and abroad. The primary endpoint of the trial is the Objective Response Rate (ORR), as measured by RECIST (Response Evaluation Criteria in Solid Tumors) criteria.