A steering committee has put a phase IIB/III study of desmoteplase on hold until further data have been analyzed. The study is evaluating the effects of desmoteplase in patients with acute ischemic stroke.
The steering committee followed a recommendation by the independent Data Monitoring Committee (DMC). The DMC had requested additional data in order to facilitate the evaluation of a potential safety signal.
Desmoteplase, the most specific plasminogen activator known today, is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus.
Currently in phase III, Desmoteplase has been successfully tested in two independent phase II studies for the treatment of acute ischemic stroke between 3 and 9 hours after onset of symptoms and has received fast-track designation from the FDA.
Earlier this week the FDA rejected Forest's application for a new antibiotic.