Activase alteplase tPA: Phase III data; marketed

GNE terminated its U.S. Phase III ATLANTIS trial (Alteplase ThromboLysis for Acute Noninterventional Therapy in Ischemic Stroke) after an independent Data Safety Monitoring Board concluded from an interim analysis that the trial had an extremely small statistical chance to show clinical benefit (see Technology Briefing, BioCentury Part I). The trial had enrolled 575 of a planned 1000 patients. Patients were treated with Activase or placebo within 5 hours of ischemic stroke. The trial will remain blinded until all enrolled patients have been followed for 3 months. ...