Forest/Paion's desmatoplase trial continues

US drugmaker Forest Laboratories and its development partner for desmoteplase, Aachen, Germany-based Paion AG, say that the Independent Data Monitoring Committee for their DIAS-2 Phase IIb/III study has recommended the resumption of patient enrollment into it with no modification of the protocol.

At this meeting, the IDMC reviewed data from 170 subjects randomized into the study, which is evaluating Paion/Forest's drug candidate in patients with acute ischemic stroke. The companies continue to expect that enrollment will be completed by the end of 2006 and that study results will be available by the middle of 2007.

According to the firms, desmoteplase is the most specific plasminogen activator known today. It is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. Currently in Phase III development, desmoteplase has been successfully tested in two independent Phase II studies for the treatment of acute ischemic stroke between three and nine hours after onset of symptoms and has received fast-track designation from the US Food and Drug Administration.