Published on January 3, 2010 at 11:13 PM
D-Pharm Ltd (TASE:
DPRM) announced enrollment 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 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.
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.
SOURCE D-Pharm Ltd
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Posted in: Drug Trial News | Medical Condition News
Tags: Alzheimer's Disease, Bipolar Disorder, Brain, Brain Cell, Cancer, Epilepsy, Lipids, Migraine, Placebo, Prophylaxis, Stroke