ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) today announced that it is discontinuing the Phase 3 EPIC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) trial of Iclusig® (ponatinib) in patients with newly diagnosed chronic myeloid leukemia. ARIAD and the U.S. Food and Drug Administration mutually agreed that the trial should be terminated because arterial thrombotic events were observed in patients treated with Iclusig. This decision was made in the interest of patient safety based on a recent assessment of data in the clinical trial.
"Our decision to stop the EPIC trial at this time is based on our current evaluation of the safety data in the trial since it was placed on partial clinical hold last week,"stated Timothy P. Clackson, Ph.D., president of research and development and chief scientific officer at ARIAD. "We believe that this is in the best interests of patient safety and the overall development of Iclusig."
Patients in the EPIC trial are being removed from treatment and will be transferred to the care of their physician. ARIAD announced in early September that fifty percent of patients, or approximately 264 patients, had been enrolled in the EPIC trial by that time. Final enrollment is 307 patients.