Forest desmoteplase
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Forest is initiating a Phase IIb/III study of its stroke agent desmoteplase "to confirm expanded nine-hour treatment window seen in two Phase II studies," the company says Feb. 7. Current treatment (Activase) has a three-hour window. The Desmoteplase in Acute Ischemic Stroke (DIAS2) parallel-design, dose-ranging study will enroll over 150 patients. Data from the DEDAS study, presented at the International Stroke Conference Feb. 4, showed that the novel plasminogen activator improved clinical outcome after 90 days versus placebo, Forest says, although the trial was not powered to show statistical differences. Desmoteplase is derived from the saliva of vampire bats...