ARIAD Pharmaceuticals Inc. announced the initiation of the randomized Phase 3 trial of ponatinib, its investigational pan-BCR-ABL inhibitor, in adult patients with newly diagnosed chronic myeloid leukemia (CML). The EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial is designed to provide definitive clinical data to support regulatory approval of ponatinib in treatment-naïve CML patients. The efficacy of ponatinib will be assessed in comparison to imatinib based on evaluation of the primary endpoint of major molecular response (MMR) rate at 12 months. ARIAD expects to complete patient enrollment in the trial by the end of 2013.
“The start of the EPIC trial represents an important milestone in the development of ponatinib in CML and builds on the strong clinical data that we have obtained to date in patients with more advanced disease. We have designed the EPIC trial with comprehensive and well-aligned input from key opinion leaders and regulatory authorities in the United States, Europe and Japan and anticipate strong interest from investigators and their patients,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD.
Dr. Berger added, “The treatment of newly diagnosed CML patients has shifted in recent years to the use of second-generation BCR-ABL inhibitors. The EPIC trial will evaluate whether ponatinib – a pan-BCR-ABL inhibitor – produces anti-leukemic responses in these newly diagnosed patients and potentially prevents the emergence of resistance mutations seen with other tyrosine kinase inhibitors.”
Date: July 27, 2012
Source: ARIAD Pharmaceuticals Inc.
Filed Under: Drug Discovery
