REHOVOT, Israel, October 31, 2011–/PRNewswire/–
D-Pharm Ltd (TASE: DPRM) today announced that the interim Report for the study of DP-b99 MACSI expected in March, 2012. The report will be based on an analysis of the futility of the data obtained from patients that completed the first 350 following the period of the ride. D-Pharm's Board of Directors and Steering Committee approved this step after MACSI approval is received from the u.s. Food and Drug Administration (FDA) for the Division of Neurology products, and it is evident that this will not prejudice the Special Protocol assessment agreement (SPA) given by the FDA in April 2010.
The study enrolled patients MACSI 770, with recruitment in more than 150 clinical sites in North America, Europe, South America, South Africa and Israel. Protocol, recently published in the International Journal of Stroke, FDA agrees with the United States under a special protocol assessment procedure (SPA) and program development of DP-b99 has been given the status of the tracked by the United States FDA.
DP-b99 is a broad spectrum of neuroprotective drugs which uniquely addresses the brain damage the process array in stroke patients. Preclinical and clinical phases I and II studies show the efficacy and safety profile that is profitable for the DP-b99. In a Phase IIb trial in patients with ischemic stroke 150, DP-b99 doubled the number of patients who recover from ischemic strokes. DP-b99 may be provided in a nine-hour therapeutic window.