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Rehovot-based Pharmaceutical Firm Advised to Extend the Study of Its Neuroprotective Drug
Based in Rehovot's Industrial Science Park Israeli "D-Pharm announced today that its 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. DP-b99 is a unique neuroprotective drug that addresses the array of damaging processes occurring in the brains of stroke patients.
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 has 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 favourable." said Dr Gilad Rosenberg, D-Pharm's VP, Research and Clinical Development.
The interim trial data review was blinded and the patients were split into groups A or B without disclosure of active drug or placebo designation. No differences were found between the two groups with respect to adverse events and no difference was observed between sub-populations for serious adverse events. Both groups were comparable for most baseline characteristics , including mean NIH Stroke Scale score. The Board evaluated clinical, laboratory and electrocardiographic data. The rate, nature and distribution of adverse events were similar in both groups.
The current Phase II study aims to recruit 150 acute stroke patients in more than 20 centres in Germany and Israel. The study results are expected to be available in the summer of 2006.
DP-b99 is administered intravenously over 4 days with the first administration up to 9 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 patient population and therapeutic window for DP-b99.
Stroke is the leading cause of neurological disability worldwide and reflects a considerable unmet need in effective acute stroke therapy, which DP-b99 aims to address..."
Source: D-Pharm Announces the Second Recommendation of an Independent Safety Monitoring Board to Continue the Phase II Study of DP-b99 in Acute Stroke Patients. PRNewswire (7 March 2006) [FullText]
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 has 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 favourable." said Dr Gilad Rosenberg, D-Pharm's VP, Research and Clinical Development.
The interim trial data review was blinded and the patients were split into groups A or B without disclosure of active drug or placebo designation. No differences were found between the two groups with respect to adverse events and no difference was observed between sub-populations for serious adverse events. Both groups were comparable for most baseline characteristics , including mean NIH Stroke Scale score. The Board evaluated clinical, laboratory and electrocardiographic data. The rate, nature and distribution of adverse events were similar in both groups.
The current Phase II study aims to recruit 150 acute stroke patients in more than 20 centres in Germany and Israel. The study results are expected to be available in the summer of 2006.
DP-b99 is administered intravenously over 4 days with the first administration up to 9 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 patient population and therapeutic window for DP-b99.
Stroke is the leading cause of neurological disability worldwide and reflects a considerable unmet need in effective acute stroke therapy, which DP-b99 aims to address..."
Source: D-Pharm Announces the Second Recommendation of an Independent Safety Monitoring Board to Continue the Phase II Study of DP-b99 in Acute Stroke Patients. PRNewswire (7 March 2006) [FullText]
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