FDA Clearance To Increase Dose Level In Cethrin Phase I/IIa Clinical Trial
U.S. Food and Drug Administration has authorized an increase in the dose level of Cethrin to 9mg in Alseres Pharmaceuticals's ongoing Phase I/IIa clinical study for the treatment of acute spinal cord injury (SCI).
In April, the Company announced that dosing at the 9mg level had begun in Canadian trial sites under a Canadian Clinical Trial Application.
Patients with acute SCI are enrolled in the open label study at sites across Canada and the United States. Previous dose groups included in the study were 0.3mg, 1mg, 3mg and 6mg. 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) rating scale. That means 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 four times the conversion rate seen with the standard of care reported in the literature (6.7%, Burns, J. Neurotrauma, 2003). When subgroups of patients treated with Cethrin are analyzed, patients with cervical injuries exhibit a more pronounced response compared to patients with thoracic injuries, showing a conversion rate that is six to seven times greater than the full patient group treated with the standard of care reported in the publication above. In patients with cervical injuries, the interim efficacy data also suggest that the response rate observed is dose dependent at the doses tested to date.
"We are pleased that the FDA has authorized the use of the 9mg dose of Cethrin and allowed the continuation of this trial at the Company's U.S. clinical trial sites," commented Mark Hurtt, Alseres' Chief Medical Officer. "We believe that this action will further support our efforts to design a well-controlled Phase IIb/III clinical study in the coming months."
By the end of the third quarter, the Company plans to meet with regulatory authorities to review its plans for its proposed Phase IIb/III clinical study. If agreement with regulatory authorities can be reached in a timely manner, the Company expects to begin the Phase IIb/III clinical study by the end of the year or early 2008.
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.