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Alseres Pharmaceuticals Concludes Enrollment in the Cethrin(R) Phase I/IIa Clinical Trial in Acute Spinal Cord Injury
Date:1/7/2008

rietary protein that inactivates the action of Rho, a key enzyme that prevents axon regeneration and recovery after SCI. It has been granted Orphan Drug Status in the U.S. In February 2005, enrollment began in an open-label, non-placebo-controlled, dose-escalating Phase I/IIa trial in subjects with acute SCI at sites in the United States and Canada. The trial assessed 5 dose levels of Cethrin from 0.3 mg to 9 mg in both thoracic and cervical injuries.

The trial design includes a number of post-treatment evaluations of the subjects for safety and efficacy for up to one year after treatment. The efficacy measurements assess changes in subjects' sensory and motor functions, as well as overall recovery as measured by the American Spinal Injury Association, or ASIA, Impairment Scale. The ASIA Impairment Scale is used to score subjects within five categories from A to E, with A being complete impairment with no sensory or motor function below the site of injury and E being normal. Grades B through E designate increasing levels of motor and sensory function. The subjects in the Cethrin Phase I/IIa trial suffered a complete thoracic or cervical SCI and were thus classified as an A on the ASIA Impairment Scale at the time of enrollment in the trial.

The 6-month interim data on 37 of these subjects treated with doses of up to 6 mg indicate that 27% of the Cethrin treated subjects improved from ASIA A to ASIA B or better. This is more than 400% greater than the conversion rate seen with the standard of care in a similarly designed study reported by Burns and colleagues in the Journal of Neurotrauma. 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.
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SOURCE Alseres Pharmaceuticals, Inc.
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