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news.D-Pharm, a clinical stage biopharmaceutical company, has submitted investigational new drug application and special protocol assessment packages to the FDA for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients.
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D-Pharm plans to initiate the trial later in 2009 following FDA review of the investigational new drug (IND) application and special protocol assessment (SPA). Recently, D-Pharm also obtained scientific advice from the European Medicines Agency on the development strategy for DP-b99 in Europe.
The planned Phase III trial is a randomized, double-blind, placebo-controlled study designed to compare the effect on ischemic stroke outcome between a placebo group and a group of patients treated with 1mg/kg/day of DP-b99 for four 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.
Alex Kozak, CEO and president of D-Pharm, said: “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.”