ARIAD Pharma (ARIA) Hits Halfway Mark in Iclusig Phase 3 Enrollment

September 4, 2013 7:42 AM EDT
ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA) announced enrollment of fifty percent of the patients planned in its randomized Phase 3 trial of Iclusig® (ponatinib) in adult patients with newly diagnosed chronic myeloid leukemia (CML). The trial, formally known as EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia), is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients.

An interim analysis of efficacy -- focused on the primary endpoint of major molecular response rate (MMR) at twelve months -- will be performed in the third quarter of 2014 based on the patients enrolled to date. Approximately 264 patients have been enrolled in the EPIC trial, and full patient enrollment of approximately 500 patients in the trial is anticipated by the end of 2013.

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