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news.D-Pharm's independent safety monitoring board has issued a second recommendation to continue the ongoing phase II study of its neuroprotective agent DP-b99 in acute stroke patients.
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DP-b99 is a unique neuroprotective drug that addresses the array of damaging processes occurring in the brains of stroke patients. After a number of failed trials for neuroprotective medicines, the positive decision of the safety board in this case is encouraging.
It is notoriously difficult to progress a stroke drug through clinical testing due to the acute nature of stroke treatment and associated safety concerns.
The safety monitoring board, which includes experts in neurology, cardiology and clinical pharmacology, reviewed the safety data of 107 subjects enrolled into the study, and recommended the study continue in its present design.
“The current review of the safety monitoring board concurs with previous safety evaluations of DP-b99 in patients. It is encouraging to observe that as the enrolment continues and the number of study subjects grows DP-b99’s safety profile remains favorable.” said Dr Gilad Rosenberg, D-Pharm’s VP of research and clinical development.
The current phase II study aims to recruit 150 acute stroke patients in more than 20 centers in Germany and Israel. The study results are expected to be available in the summer of 2006.