REHOVOT, Israel, October 31, 2011 /PRNewswire/ --
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.
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.
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.
D-Pharm (http://www.dpharm.com) is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics, and has generated a rich pipeline of patent protected proprietary products. D-Pharm's pipeline includes advanced clinical stage products, DP-b99 for treatment of ischemic stroke patients and DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and prophylaxis of migraine. DP-VPA, a prodrug of valproic acid, is in Phase II clinical development. DP-460 is in preclinical development intended as an oral, disease-modifying therapy for Alzheimer's disease. Other mimics of bioactive lipids, LipidoMimetix, are at an earlier developmental stage for cancer.
D-Pharm was established in 1993 at the initiative of 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%).
Statements in this press release that are not historical facts are forward-looking information, as defined in the Securities Law, based on information available to D-Pharm at the time of this press release. The estimations could, some or all, be unrealized, or could be realized in significantly different ways than expected.
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SOURCE D-Pharm Ltd