NEW YORK, Oct.25 -- Forest Laboratories, Inc. and its development partner for desmoteplase, PAION AG (Aachen, Germany), today 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 upon this recommendation. The requested data has been processed and will be provided to the DMC within the next day.
What the heck is desmoteplase?
Desmoteplase is a specific plasminogen activator that is a genetically engineered version of a clot-dissolving protein found in the saliva of vampire bats. So what's that? Plamsinogen is the inactive precursor protein of plasmin which is a serine protease that dissolves blood clots in the body.
Currently in Phase III, Desmoteplase has been successfully tested in two independent Phase II studies for the treatment of acute ischaemic stroke between 3 and 9 hours after onset of symptoms and has received fast-track designation from the U.S. Food and Drug Administration.
Forest laboratories (NYSE: FRX) ended trading today down 2.7% at $48.08.
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