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
Prior to the IND submission D-Pharm successfully completed the program
outlined at the pre-IND meeting held with the FDA in
The planned 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 in over 100 clinical
"I am especially pleased with this achievement since bringing DP-b99 from
design to Phase III really reflects the company's ability to adapt and mature
along with our lead product. I look forward to agreement on the SPA and
commencing our Phase III trial with DP-b99 under IND" said
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.
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: firstname.lastname@example.org
SOURCE D-Pharm Ltd