D-Pharm Completes Pre-IND Meeting With The FDA For Treatment Of Acute Stroke With DP-b99

Main Category: Stroke
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharmacy / Pharmacist
Article Date: 05 Mar 2008 - 0:00 PDT

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D-Pharm announced that it has held its Pre-IND (Investigational New Drug) meeting with the FDA to discuss the forthcoming IND submission for DP-b99, a novel drug to aid recovery following acute stroke. The Pre-IND meeting focused on the proposed plans for the Phase III clinical program and the discussion included clinical trials to date, preclinical pharmacology, toxicology data and the FDA requirements and suggestions for the IND submission. DP-b99 is a unique drug protecting brain cells in stroke patients, discovered and developed by D-Pharm.

Alex Kozak, PhD, President and CEO of D-Pharm, said "The positive and constructive feed-back we've received from the FDA is most encouraging. With a number of uncertainties in the developmental program removed we may now follow a clear path towards an IND application for a pivotal Phase III study towards the end of this year. This is good news for D-Pharm and for stroke patients."

Most recently, D-Pharm successfully completed a Phase IIb trial for DP-b99 in 150 ischemic stroke patients. Results from this study will be published shortly in the peer reviewed journal, Stroke. DP-b99 statistically significantly increased by two-fold the percentage of patients that completely recovered from ischemic stroke. In addition, DP-b99 has at least a 9hr therapeutic window and may be safely administered in this patient population.

D-Pharm has commenced preparations for the pivotal Phase III trial, including manufacturing of the drug, certain customary studies and IND submission. The Phase III trial is expected to commence in 2009 and to recruit about 750 moderately severe acute stroke patients in North America, Europe and Asia. D-Pharm will be seeking a suitable CRO for the next study with DP-b99.

About Stroke

Every year approximately 750,000 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 mean lifetime cost resulting from an ischemic stroke is estimated at $140,000 per patient. 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 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 and DP-VPA, a novel drug for treatment of epilepsy, bipolar disorder and migraine prophylaxis, currently in Phase II 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 Ltd
http://www.dpharm.com

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