REHOVOT, Israel, June 14, 2011 /PRNewswire/ --

D-Pharm Ltd., (TASE: DPRM) announced today publication, on-line, in the International Journal of Stroke the protocol for its ongoing, Phase III, Membrane Activated Chelator Stroke Intervention (MACSI) study. In this study, DP-b99 is being tested for safety and for the ability to improve outcome in moderately severe acute ischemic stroke patients. The article is available on-line at the following link and will appear in the journal''s August, 2011 print edition.

Dr. Gilad Rosenberg, D-Pharm''s V.P. of Clinical Development commented; "DP-b99 is the most advanced industry-developed neuroprotective agent in clinical development. Benefitting from the MACSI Steering Committee''s many years of experience in clinical stroke research, we have gone to a great effort to include an innovative trial design that incorporates many of the lessons learned from past studies."

The MACSI study is one on the largest randomized, double blind, placebo-controlled Phase III stroke studies currently ongoing. Its primary objective is to evaluate the safety and therapeutic effects of intravenous 1.0mg/kg/day DP-b99, initiated within nine-hours of stroke onset in patients with moderately severe hemispheric acute ischemic stroke. The primary efficacy outcome is the mRS score at day 90 which will be compared between treatment groups using a 'shift', or distribution, analysis.

The MACSI study is enrolling 770 patients, with recruitment in over 100 clinical sites in North America, Europe, South America, South Africa and Israel. The protocol, now published, 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.

According to the MACSI protocol, a Data Safety Monitoring Board (DSMB), should periodically review safety data from patients enrolled into the study. The DSMB, which includes independent experts in stroke, neurology and biostatistics, recently recommended to the MACSI Steering Committee that the study continue in its present design without changes to the protocol.