D-Pharm announces expected date of interim report for the DP-b99 Acute Ischemic Stroke Study, MACSI

D-Pharm Ltd., (TASE: DPRM) announced today that the interim report for the DP-b99 MACSI study is expected in February, 2012. The report will be based on the futility analysis of the data obtained from first 350 patients that complete the follow up period. D-Pharm’s Board of Directors and the MACSI Steering Committee approved this move after consent was received from the US Food and Drug Administration (FDA) Division for Neurology Products, and it was confirmed that this would not prejudice the Special Protocol Assessment (SPA) agreement granted by the FDA in April 2010.
The MACSI study is enrolling 770 patients, with recruitment in over 150 clinical sites in North America, Europe, South America, South Africa and Israel. The protocol, published recently in the International Journal of Stroke, was agreed with the U.S. FDA under the Special Protocol Assessment (SPA) procedure and the DP-b99 development program has been granted Fast Track status by the U.S. FDA.
About DP-b99
DP-b99 is a unique broad-spectrum neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients. Both preclinical and clinical Phase I and II studies indicate a favorable efficacy and safety profile for DP-b99. In the Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window.
About Stroke
Every year around 1.5 million people in the U.S., Western Europe and Japan suffer an acute stroke. Stroke is a leading cause of death in the western world and around 50% of stroke survivors suffer from some form of severe disability. According to the American Heart Association (AHA) the annual economic burden of stroke in the U.S. was around $70B in 2009. Currently, between 2-5% of stroke patients receive tissue plasminogen activator (tPA), the only drug currently approved for treatment of acute stroke in the U.S.