The safety monitoring board, which includes experts in neurology, cardiology and clinical pharmacology, reviewed the safety data of the first 62 subjects enrolled into the study, and has recommended the study continue in its present design.
“In the last two decades a very high proportion of failures in stroke trials have been due to safety issues,” said Alex Kozak, Chief Executive of D-Pharm. “Our goal is to develop an effective drug to protect brain cells after stroke that causes no further harm to patients. With today’s decision, DP-b99 has passed an important juncture of its clinical development.”
This favorable judgment confirms the results of D-Pharm’s previous DP-b99 phase IIa study in stroke, in which the safety profile of DP-b99 did not significantly differ from that of placebo.
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.
DP-b99 is administered intravenously over four days with the first administration up to nine hours following stroke onset. The patient group is stratified into those treated within six hours and within nine hours following stroke onset. D-Pharm expects this study to clearly define the optimal therapeutic window for DP-b99.