D-Pharm Submits Investigational New Drug Application
Application and Special Protocol Assessment to the FDA for Phase III Trial of DP-b99 in Acute Stroke Patients
REHOVOT, Israel, May 6 /PRNewswire/ -- D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients. D-Pharm plans to initiate the trial later this year following FDA review of the IND and SPA. Recently, D-Pharm also obtained Scientific Advice from the European Medicines Agency (EMEA) on the development strategy for DP-b99 in Europe.
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.
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 sites in North America, Europe, South Africa and Israel.
"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 Alex Kozak, PhD, CEO and President of D-Pharm.
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.
National Stroke Association’s mission is to reduce the incidence and impact of stroke by developing compelling education and programs focused on prevention, treatment, rehabilitation and support for all impacted by stroke.