PAION, FOREST TO RESUME STROKE STUDY
Paion announced that the independent data monitoring committee (DMC) for the company's DIAS-2 Phase III study met and informed the steering committee, Paion and its development partner for desmoteplase, Forest Laboratories, that it has reviewed the cumulative data from the study provided by the companies and recommended that patient enrollment resume with no modification of the protocol. The DMC reviewed data from 170 randomized patients. The DIAS-2 study is evaluating Paion's drug candidate desmoteplase in patients with acute ischaemic stroke. The companies expect that enrollment will be completed by the end of 2006 and that study results will be available by the middle of 2007.
"We are reassured by the DMC's recommendation and are looking forward to complete the study as an important milestone in the development of this potentially breakthrough stroke medication," Paion CEO Wolfgang Soehngen 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.