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www.fdanews.com/articles/68031-arqule-enrolls-first-patient-in-phase-ib-ii-trial-of-arq-501-gemcitabine

ArQule Enrolls First Patient in Phase Ib/II Trial of ARQ 501, Gemcitabine

January 26, 2005

ArQule has successfully enrolled its first patient in a Phase Ib/II combination trial of ARQ 501 and gemcitabine.

The Phase Ib component is an open-label, dose-escalation study that is being conducted at two leading clinical research sites in the U.S., enrolling patients with advanced cancer, some of whom may have previously received gemcitabine.

ArQule anticipates this component will be followed by a Phase II study exploring the use of ARQ 501 and gemcitabine in patients with advanced cancer.

The Phase Ib/II study is being conducted by ArQule as part of its strategic alliance with Roche to explore novel activators of the E2F pathway.