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news.D-Pharm has completed enrollment in its phase IIb clinical trial of DP-b99, a unique neuroprotective drug that addresses the array of damaging processes occurring in the brains of stroke patients.
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The phase IIb trial results are expected to be available towards the end of 2006 following completion of the three month follow-up period.
“Patient enrolment into stroke trials is notoriously difficult to plan, therefore, I’m very satisfied that we’ve managed to complete enrolment without major delays,” said Dr Gilad Rosenberg, D-Pharm’s VP of clinical development.
The double blind, placebo controlled, multi-center, international trial is designed to reconfirm the efficacy and beneficial effect of DP-b99 previously observed in stroke patients, as well as to strengthen and extend the safety data obtained from the phase IIa study.
The study enrolled patients with ischemic stroke accompanied by language dysfunction, visual field defect or inattention with a baseline NIH Stroke Scale score of seven to 20. Patients were recruited in 25 centers in Germany, Israel and latterly also in South Africa.
In addition to confirming safety and efficacy, 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.