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news.Israeli biopharmaceutical company D-Pharm has announced that its neuroprotective compound for the treatment of acute ischemic stroke patients met its phase IIb trial goals.
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The phase IIb placebo controlled trial to assess the drug, DP-b99, was completed in December 2006.
The study enrolled 150 ischemic stroke patients with signs of cortical involvement and NIH Stroke Scale (NIHSS) score of 7-20. DP-b99 (1mg/kg/day) or placebo was administered within 1-9 hours of stroke-onset as a four-day course of once-daily two hour infusions with a 90-day follow-up.
According to D-Pharm, the day 90 recovery rate in the DP-b99 treated group was two times higher than in the placebo group. D-Pharm said that these phase IIb trial results show that DP-b99 doubled the chances of recovering from an ischemic stroke, has at least a 9 hour therapeutic window and is safe.
The company is now planning to commence a pivotal phase III study of DP-b99 in 2008.