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ARIAD Pharma Reveals Changes In Clinical Development Program Of Iclusig

ARIAD Pharmaceuticals, Inc. (ARIA) reported its review results of updated clinical data from the pivotal PACE trial of Iclusig and actions that it is taking certain consultations with the U.S. Food and Drug Administration or FDA.

The company said the patient enrollment in all trials of Iclusig is being paused, and would be resumed with expected changes in dose and other modifications.With the aid of this action, the FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig. Patients who are currently receiving Iclusig in studies would continue on therapy, and reductions in Iclusig dose from 45 mg daily would be implemented on a trial-by-trial basis for those whose Iclusig treatment is ongoing.

The Iclusig dose in patients who are now enrolled in the EPIC study would be reduced to 30 mg daily unless they have achieved a major molecular response or reach one in the future, in which case the dose would be reduced further to 15 mg daily.

The PACE trial data showed continued efficacy after dose reduction. Out of the 270 chronic-phase patients in the pivotal study, 190 patients dose reduced to either 30 mg or 15 mg. Of 110 patients who initially achieved a major cytogenetic response, more than 90% of these patients maintained this response after a median follow up of 19 months, despite dose reduction, ARIAD Pharmaceuticals added.

The company's shares are currently down by more than 50% in the pre-market trading, following this news.

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