Ariad falls on EPIC's end

Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) fell $1.83 (41%) to $2.67 on Friday after discontinuing the confirmatory Phase III EPIC trial evaluating Iclusig ponatinib in newly diagnosed leukemia patients due to arterial thrombotic events observed in patients treated with the drug. Ariad said the decision was based on an analysis of safety data from the trial that was conducted after FDA placed a partial clinical hold last week on all trials of Iclusig. EPIC had enrolled 307 patients of a planned 500.

Ariad plummeted 66% to $5.83 last Wednesday on FDA's partial hold, which came after two-year follow-up data from the pivotal Phase II PACE trial showed longer use of Iclusig was associated with an increase in treatment-emergent serious arterial thrombotic events. PACE evaluated Iclusig in heavily pretreated patients. Data from the trial were the basis for accelerated approval for Iclusig; the two-year follow-up data are required to secure full approval (see BioCentury Extra, Oct. 9). ...