D-Pharm Receives FDA Clearance to Commence a Phase III Trial of DP-b99 in Acute Stroke Patients
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
Prior to the IND submission D-Pharm successfully completed the program
outlined at the pre-IND meeting held with the FDA in
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.
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
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 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.
For further information please contact: Tami Horovitz, PhD. Tel: +972-8-9385100 Fax: +972-8-9300795 Email: email@example.com
SOURCE D-Pharm Ltd