Ariad Halts Iclusig Trial; Shares Plunge Over 38%

(RTTNews) - Shares of Ariad Pharmaceuticals Inc. (ARIA) plunged 38 percent Friday, after having halted a late-stage trial of Iclusig in patients with newly diagnosed chronic myeloid leukemia.

The decision was taken in tandem with the U.S. Food and Drug Administration as arterial thrombotic events were observed in patients treated with Iclusig (ponatinib).

The late-stage trial - EIPC (Evaluation of Ponatinib versus Imatinib in Chronic Myeloid Leukemia) - was a randomized, two-arm trial that sought to compare the efficacy of ponatinib with that of imatinib in adult patients with newly diagnosed CML in the chronic phase.

Patients in the trial had to be at least 18 years of age and diagnosed with CML within six months prior to enrollment. About 500 patients were to be randomized 1:1 to the standard dose of ponatinib (45 mg given orally once daily) or imatinib (400 mg given orally once daily). The primary endpoint of the trial was major molecular response at 12 months of treatment.

Iclusig is a kinase inhibitor. The drug is available in the U.S. and EU for patients with resistant or intolerant CML and Philadelphia-chromosome positive acute lymphoblastic leukemia. Ariad said it will continue to work with health authorities to make suitable changes to the Iclusig labeling.

Ariad stock is trading at $2.77, down $1.73 or 38.42%, on a volume of 38 million shares. In the last 52 weeks, the stock traded in the range of $2.62 - $24.85.