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www.fdanews.com/articles/61395-d-pharm-enrolls-acute-stroke-patients-for-dp-b99-trial

D-PHARM ENROLLS ACUTE STROKE PATIENTS FOR DP-B99 TRIAL

August 2, 2006

D-Pharm has completed enrolment in its Phase IIb trial of DP-b99, a neuroprotective drug that addresses several damaging processes that occur in the brains of stroke patients. Results are expected to be available toward the end of 2006 after the three-month follow-up period.

The double-blind, placebo-controlled, multicenter trial is designed to reconfirm the efficacy and beneficial effect of DP-b99 previously observed in stroke patients, as well as to strengthen and extend the safety data obtained from the Phase IIa study. The study enrolled patients with ischemic stroke accompanied by language dysfunction, visual field defect or inattention with a baseline NIHSS score of seven to 20. Patients were recruited in 25 centers in Germany, Israel and South Africa. In this trial DP-b99 will be administered intravenously, once daily over four days, with the first administration occurring up to nine hours following stroke onset. D-Pharm expects this study to clearly define the optimal patient population and therapeutic window for DP-b99.