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D-Pharm Submits Investigational New Drug Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients
Date:5/6/2009

l 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.

About DP-b99

DP-b99 is a unique neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients and emerged from D-Pharm's proprietary Membrane Activated Chelator (MAC) platform technology. D-Pharm successfully completed extensive testing of DP-b99 in pre-clinical and then in Phase I and Phase II clinical studies. Both preclinical and clinical studies indicate a favorable efficacy and safety profile for DP-b99. In the recently completed Phase IIb trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that completely recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window.

About Stroke

Every year approximately 780,000 Americans have a new or recurrent stroke. The second most common cause of death worldwide, stroke is also the leading cause of serious long-term disability; 15% to 30% of stroke survivors experience permanent disability. According to the American Heart Association, the estimated direct and indirect cost in 2009 of stroke in the US is $68.9 billion. Other than tissue plasminogen activator (tPA), which must be administered 3 hours after stroke, there are no FDA approved medicines for this indication.

About D-Pharm Ltd.

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 acute ischemic stroke patients and DP-VPA, a novel dr
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SOURCE D-Pharm Ltd
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