Reopro Ischemic Stroke Trial Halted
This article was originally published in The Pink Sheet Daily
Executive Summary
Centocor and Lilly are permanently discontinuing a Phase III study of Reopro (abciximab) for acute ischemic stroke after the study's independent Safety & Efficacy Monitoring Committee confirmed concerns about intracranial hemorrhage that previously prompted the firms to suspend enrollment
Centocor and Lilly are permanently discontinuing a Phase III study of Reopro (abciximab) for acute ischemic stroke after the study's independent Safety & Efficacy Monitoring Committee confirmed concerns about intracranial hemorrhage that previously prompted the firms to suspend enrollment. Patient enrollment in the Abciximab in Emergent Stroke Treatment Trial-II was put on hold in September (1 (Also see "Centocor/Lilly’s Reopro Phase III Ischemic Stroke Study Suspended" - Pink Sheet, 4 Oct, 2005.)). "The new recommendation comes after the SEMC reviewed additional efficacy and safety data on most of the 808 enrolled patients to help determine if the benefit-risk profile warranted continuing the study," the firms said in a joint statement Oct. 28. Reopro is currently approved as adjunct therapy in certain percutaneous coronary interventions. |