ARIAD Reaches 50% Patient Enrollment In Late-stage EPIC Trial Of Iclusig

(RTTNews) - ARIAD Pharmaceuticals, Inc. (ARIA) Wednesday 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 or 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.

The primary endpoint is major molecular response rate or MMR at twelve months. Key secondary endpoints include MMR at five years and molecular response or MR at three months.

An interim analysis of efficacy will be performed in the third quarter of 2014 based on the patients so far enrolled. Two hundred and sixty-four patients have been enrolled in the EPIC trial, and full patient enrollment of approximately 500 patients in the trial is expected by the end of 2013.

Harvey Berger, CEO of ARIAD, said, "Depending on the outcome of the interim analysis, we may be able to file for regulatory approval of Iclusig in this front-line setting approximately six months earlier than currently planned."