D-Pharm Receives FDA Clearance To Commence A Phase III Trial Of DP-b99 In Acute Stroke Patients

Main Category: Stroke
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 09 Jun 2009 - 0:00 PDT

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D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the trial in the coming months, in over 100 clinical sites in North America, Europe, South Africa and Israel.

The forthcoming Phase III trial is a randomized, double blind, placebo-controlled study (study acronym MACSI: Membrane Activated Chelator Stroke Intervention). It is designed to compare the effect on ischemic stroke outcome between a placebo group and a group of patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. D-Pharm plans to enroll 770 moderate to severely affected ischemic stroke patients worldwide, with first patients expected to be recruited in Israel and South Africa.

Dr. Gilad Rosenberg, D-Pharm's VP Clinical Development commented, "The FDA's IND procedure involved review of the entire DP-b99 data set. Following 30 days for review of our IND application, the FDA has no further questions relating to DP-b99's CMC, preclinical and clinical data package. I'm very pleased that the Agency is satisfied with our data and we can move forward with this important study without delay."

Prior to the IND submission D-Pharm successfully completed the program outlined at the pre-IND meeting held with the FDA in January 2008. The program included additional toxicity studies, a drug interaction study with rtPA, and an interaction study with warfarin in healthy volunteers, as well as scale-up and optimization of the DP-b99 manufacturing process.

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. Only about 2 to 5% of acute stroke patients are eligible for treatment with tissue plasminogen activator (tPA), the only FDA approved drug treatment for acute stroke.

$68.9 billion. Only about 2 to 5% of acute stroke patients are eligible for treatment with tissue plasminogen activator (tPA), the only FDA approved drug treatment for acute stroke.

About D-Pharm Ltd.

D-Pharm 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 drug for treatment of epilepsy, bipolar disorder and prophylaxis of migraine. 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.

Source: D-Pharm Ltd