REHOVOT, Israel, April 15, 2010 /PRNewswire-FirstCall/ -- D-Pharm Ltd (DPRM: TASE) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for a pivotal phase 3 trial (MACSI) of its neuroprotective agent DP-b99 in acute ischemic stroke patients. The SPA agreement letter indicates that "the design and planned analysis of the study adequately address the objectives necessary to support a regulatory submission" of the drug for marketing approval, a New Drug Application (NDA).
Dr. Gilad Rosenberg, D-Pharm's VP Clinical Development commented: "The FDA thoroughly reviewed this protocol and issued an SPA agreement letter - the same FDA that will have to eventually rule whether DP-b99 may receive marketing authorization in the USA. Their agreement to the protocol attests to the adequacy of the MACSI trial design, and confirms that the MACSI results, if positive, will be able to support a New Drug Application submission. As such, the SPA agreement represents an auspicious development of major significance."
About the Phase 3 MACSI Trial
The MACSI trial is a double blind, randomized, placebo controlled, parallel group, multicenter and multinational phase 3 pivotal study to compare, using mRS "Shift Analysis" at Day 90, the therapeutic effects of 1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo, in subjects with moderately severe, likely hemispheric, acute ischemic stroke. Treatment will be initiated within nine hours of acute ischemic stroke onset. The safety and tolerability of DP-b99 will be assessed, as well as post-stroke recovery according to mRS and NIHSS Day 90 scores.
The study will enroll 770 patients, with recruitment started at some of the 140 clinical sites in Europe, USA, Canada, Brazil, South Africa, Israel and South Korea.
About the SPA
Special Protocol Assessment (SPA) is an instrument of the FDA for evaluating protocols and reaching agreement with sponsors on the design of clinical trials that can be used for drug approval. In our case, it applies to a clinical protocol for a trial from which the data will form the primary basis for a claim of efficacy. In general, the SPA can significantly reduce development time since the design of the pivotal protocol has been approved in advance by the Regulator.
DP-b99, by virtue of its ability to modulate pathological levels of zinc in the vicinity of membranes, is a multi-targeted compound for the treatment of stroke that addresses an array of brain damaging processes occurring in stroke patients. DP-b99 represents a family of proprietary Membrane Activated Chelator (MAC) compounds that have potential efficacy in the treatment of a wide variety of neurodegenerative disorders.
D-Pharm successfully completed extensive testing of DP-b99 in pre-clinical and then in Phase 1 and Phase 2 clinical studies. Both preclinical and clinical studies indicate a favorable efficacy and safety profile for DP-b99. In the Phase 2b trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that completely recovered from ischemic stroke. The first patient was enrolled into the MACSI study, on schedule, in December 2009.
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.
About D-Pharm Ltd.
D-Pharm (http://www.dpharm.com) is a technology-driven biopharmaceutical company focused on the discovery and development of innovative proprietary drugs for the treatment of central nervous system disorders and cancer. D-Pharm is a leader in design and development of lipid-like medicine and its products are new chemical entities (NCEs) derived from its proprietary platform technology. The drug development pipeline includes two products in advanced stages of clinical development: DP-b99 (Ph. 3) for treatment of acute ischemic stroke patients and DP-VPA (Ph. 2) for treatment of epilepsy, bipolar disorder and prophylaxis of migraine; and preclinical drug-candidates for Alzheimer's disease and cancer.
Contact: Tami Horovitz D-Pharm Ltd. firstname.lastname@example.org Tel: +972-89385100
SOURCE D-Pharm Ltd