D-Pharm has reported enrollment of patients with acute ischemic stroke into its Phase III clinical study of DP-b99 (MACSI) at the Wolfson Medical Center, Israel.
The MACSI trial involves numerous medical centers in the US, Canada, Europe, Israel, South Africa, South Korea and Brazil. DP-b99 is D-Pharm’s product developed for protection of brain cells suffering from restricted blood and oxygen supply (ischemia).
The company said that the trial is expected to compare the stroke outcome in a group of patients treated with placebo (an inactive substance) to patients treated with 1mg/kg/day of DP-b99 for 4 consecutive days. The study is expected to enroll, in total, 770 patients at 120 – 140 clinical sites worldwide.
Recently D-Pharm met with the FDA to discuss the special protocol assessment (SPA) and will continue the dialog with the FDA towards the final agreement. The company also said that for the global development of DP-b99, D-Pharm will collaborate with its partners Yungjin Pharmaceuticals in S. Korea and Wanbang Biopharmaceuticals in China.
Gilad Rosenberg, VP of clinical development at D-Pharm’s, said: “We’re very pleased that this important clinical milestone has been achieved on schedule. The challenge is now to effectively activate the additional clinical sites to ensure a patient recruitment rate sufficient to complete the study on time, as planned.”