Alseres completes enrollment in Phase I/IIa spinal cord injury trial

The subjects in the Cethrin Phase I/IIa trial suffered a complete thoracic or cervical spinal cord injury (SCI) and were thus classified as an A on the American Spinal Injury Association (ASIA) Impairment Scale at the time of enrollment in the trial. The six month interim data on 37 of these subjects treated with doses of up to 6mg indicate that 27% of the Cethrin treated subjects improved from ASIA A to ASIA B or better. When subjects with cervical injuries who were treated with Cethrin were analyzed separately, about 46% of the subjects exhibited a conversion rate from ASIA A to ASIA B or better. Moreover, about 18% of subjects overall and 38% of subjects with cervical injuries improved to ASIA C or better over the six months the hallmark of which is recovery of some motor function. In subjects with cervical injuries, the interim efficacy data also suggest that the response rate observed is dose-dependent at the doses up to 6mg.

Alseres intends to move forward with its previously announced plans for the placebo-controlled, Cethrin Phase IIb trial in acute spinal cord injury at sites in the US, Canada, Europe and other countries in 2008.

Mark Pykett, president and COO of Alseres, said: “Interim reported data have demonstrated encouraging safety and efficacy results over a 30-fold dose range. We look forward to the initiation of the Phase IIb trial in the first half of 2008.”