Ariad Pharmaceuticals Inc. said Friday that it is discontinuing the Phase 3 EPIC trial of Iclusig in patients with newly diagnosed chronic myeloid leukemia because of the company’s current evaluation of the trial’s safety data.
The announcement comes about a week after the company said that it had stopped enrolling patients in ongoing clinical trials of its leukemia drug because new data showed an increased number suffered blood clots and heart problems in an earlier study. Ariad’s shares fell nearly 66 percent on the news. While one trial of Iclusig is being halted, more than 10 other studies of the drug are ongoing.
In Friday’s press release, Ariad said that the company and the Food and Drug Administration mutually agreed that the trial should be terminated because arterial thrombotic events were observed in patients treated with Iclusig.
The release included a statement from Timothy P. Clackson, Ariad’s president of research and development and chief scientific officer.
“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,” Clackson said. “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, the company’s release said.
While one trial of Iclusig is being halted, more than 10 other studies of the drug are ongoing. The studies look at different potential uses of the drug, including different types of patients and different types of cancer.
The ongoing trials are on what it is called “partial clincical hold.” While on partial clinical hold, those studies continue, but no new patients are being enrolled in them.
Iclusig was approved by the FDA in December as a treatment for chronic myeloid leukemia for patients who do not respond or cannot tolerate existing front-line treatments. The drug remains on the market. Iclusig had been used primarily for patients who had failed one or two of the other targeted therapies for CML.
One ongoing trial is studying the use of Iclusig as a first line treatment for patients with chronic myeloid leukemia.
If approved as a front-line treatment, Iclusig could be also prescribed for newly diagnosed patients who haven’t been treated previously. Such a label would greatly increase Iclusig’s market potential.
During a Friday morning conference call with investors, Ariad executives said Iclusig’s label will have to be revised. The FDA’s December approval of Iclusig required the drug to have a so-called black-box label, which warns doctors of potential serious side effects.
One analyst on the call asked whether it’s likely that Iclusig will be removed from the market.
Clackson replied, “We don’t believe a removal from the market is being contemplated.”
Chris Reidy can be reached at email@example.com.