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.
Subscribe to our email newsletter
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.