FOREST, PAION HALT PATIENT RECRUITMENT FOR STROKE STUDY

Forest Laboratories and its development partner for desmoteplase, Paion, have announced that the steering committee of the Phase IIB/III stroke study, DIAS-2, has decided in agreement with the companies to place patient recruitment temporarily on hold until further data have been analyzed. The DIAS-2 study is evaluating PAION's drug candidate 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, which was not specified further by the DMC. The DMC had notified the steering committee in its statement that no conclusion on the safety or efficacy of desmoteplase should be drawn based on this recommendation. The requested data has been processed and will be provided to the DMC, the companies said.

Desmoteplase, currently the most specific plasminogen activator, is a genetically engineered version of a clot-dissolving protein found in the saliva of the vampire bat Desmodus rotundus. Currently in Phase III trials, Desmoteplase has been successfully tested in two independent Phase II studies for the treatment of acute ischaemic stroke between three and nine hours after onset of symptoms and has received fast-track designation from the FDA.