D-Pharm Ltd announced enrolment of patients with acute ischemic stroke into its phase-III clinical study of DP-b99 (MACSI). The first patient has been enrolled 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 most advanced product developed for protection of brain cells suffering from restricted blood and oxygen supply (ischemia).
The MACSI study is as international, multicenter, randomized, double-blind, placebo-controlled phase-III clinical trial. The trial will compare the stroke outcome in a group of patients treated with placebo (an inactive substance) to patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. The study is expected to enrol, in total, 770 patients at 120 – 140 clinical sites worldwide.
Recently D-Pharm met with the US FDA to discuss the Special Protocol Assessment (SPA) and will continue the dialog with the FDA towards the final agreement.
Dr Gilad Rosenberg, D-Pharm’s V P Clinical Development stated, “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.”
For the global development of DP-b99, D-Pharm Ltd will collaborate with its partners Yungjin Pharmaceuticals in S Korea and Wanbang Biopharmaceuticals in China. Stroke is a leading cause of serious long-term disability and the second most common cause of death worldwide. The number of acute ischemic stroke patients in the US, Western Europe and Japan is around 1.5 million; including the territories of S. Korea and China may almost double this figure.
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 is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics and has generated a rich pipeline of patent protected proprietary products.