Ariad Pharmaceuticals Inc. (ARIA) announced Friday that it is discontinuing the Phase 3 EPIC or Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia trial of Iclusig (ponatinib) in patients with newly diagnosed chronic myeloid leukemia. The company said the decision was made in the interest of patient safety based on a recent assessment of data in the clinical trial.
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.
"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 Clackson, president of research and development and chief scientific officer at ARIAD.
The company noted that patients in the EPIC trial are being removed from treatment and will be transferred to the care of their physician.
The company 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.
Iclusig is commercially available in the U.S. and EU for patients with resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia.
The company stated that it continues to work with health authorities to make appropriate changes to the Iclusig product labeling to reflect the recently announced safety findings from the pivotal PACE trial that was the basis of its marketing approvals.
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