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Ariad Pharmaceuticals Inc Announces Analysis of Cardiovascular Risk Profile of Patients from Pivotal PACE Trial of Iclusig (Ponatinib)

Saturday, 1 Jun 2013 09:00am EDT 

Ariad Pharmaceuticals Inc announced results of evaluation of the cardiovascular risk profile of Philadelphia-positive (Ph+) leukemia patients treated with Iclusig\ (ponatinib) in the pivotal PACE trial. Serious arterial thrombotic (AT) events can be a complication of BCR-ABL tyrosine kinase inhibitor (TKI) therapy in Ph+ leukemias. In the single-arm, PACE trial, serious AT events, including cardiovascular, cerebrovascular and peripheral vascular events, occurred in 34 of 449 patients (8%). This analysis showed that patients who experienced serious ATs while on study more commonly had a history of pre-existing cardiac disease and a higher prevalence of baseline cardiovascular risk factors prior to enrollment than in those patients who did not experience these events. Of 34 patients with serious AT events reported in the PACE trial, 21 had cardiovascular events and 14 had cerebrovascular or peripheral vascular events. Pre-existing cardiac disease was present in 15 of 21 patients (71%) who had cardiovascular events and 6 of 14 patients (43%) who had cerebrovascular or peripheral vascular events on study. Further, 30 patients (88%) had at least one pre-existing cardiovascular risk factor, 14 patients (41%) had pre-existing ischemic cardiac disease, and 19 patients (56%) were at least 65 years of age. 

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