The next crucial milestone is near for the more than 15-year development of a major new ethical Israeli drug.
D-Pharm Ltd., (TASE: DPRM) announced that it will be able to determine in February if initial results for its Phase III stroke drug trial indicate enough evidence of a beneficial effect for the trial to continue.
The interim report for the DP-b99 MACSI study will be based on the futility analysis of the data obtained from the 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 FDA.
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.
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
D-Pharm was established in 1993 by Dr. Alex Kozak, President and CEO. In August 2009 the Company completed the first offering of its shares on the Tel Aviv stock exchange. The largest shareholder in the company is Clal Biotechnology Industries (46%).