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Alseres Pharmaceuticals' Announces Expansion of the Cethrin(R) Acute Spinal Cord Injury (SCI) Phase I/IIA Clinical Trial
Date:9/24/2007

ommented Dr. Mark Hurtt, Alseres' Chief Medical Officer. "The inclusion of 9 mg cervical subjects will increase our understanding of the encouraging efficacy data for Cethrin at lower doses, and provide additional safety data to support the Phase IIb/III clinical study, expected to begin patient enrollment in early 2008."

About Cethrin(R)

Cethrin is a recombinant protein drug intended to facilitate the re-growth of axons during the critical period immediately after a major injury to the spinal cord. Following an SCI, about two-thirds of patients undergo decompression/stabilization surgery. During surgery, Cethrin is delivered by a single application to the injured region of the spinal cord. Cethrin has been designated as an Orphan Drug by the FDA.

About the Cethrin(R) Phase I/IIa Clinical Trial

Patients with acute SCI are enrolled in the open label study at sites across Canada and the United States. Dose groups included in the study are 0.3mg, 1mg, 3mg, 6mg and 9mg. All patients enrolled in the trial have "complete" spinal cord injuries, referred to as "ASIA A" as assessed under the American Spinal Injury Association (ASIA) Impairment Scale. This means that each study participant suffered a complete thoracic or cervical injury (i.e. having no sensory or motor function below the level of the SCI). ASIA grades are designated from A through E, with 'A' designating complete SCI and 'E' being normal. Grades 'B' through 'D' designate increasing levels of motor and sensory improvements.

Interim results reported to date on the thirty-seven patients enrolled in the first four dose groups indicate that Cethrin is well tolerated. The interim efficacy analysis in these groups indicates that Cethrin treated patients experience a frequency of post-treatment conversions from ASIA A to ASIA B or greater which is up to four times the conversion rate seen with the standard of care reported in the literature (6.7%, Burns et al., J. Neurotrauma, 2003). Whe
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SOURCE Alseres Pharmaceuticals
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