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Results show promising neurological recovery in severely-injured, acute cervical spinal cord injury patients treated with Cethrin
HOPKINTON, MA, USA | May 12, 2008 | Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) today announced 12-month interim data from its Phase I/IIa clinical trial of Cethrin, a proprietary recombinant protein that is being investigated for its potential to restore motor and sensory function after spinal cord injury, or SCI. The trial enrolled a total of 48 patients of which 37 have reached the final 12 month follow up evaluation. The data for these first 37 patients indicate that at 6 and 12 months after treatment, 38% (5 of 13) of cervical injury patients showed marked recovery of motor and sensory function after treatment as measured by a 2-grade or better improvement in the American Spinal Injury Association, or ASIA, Impairment Scale. Analysis of the data by dose group indicates that Cethrin doses of 1 and 3 mg appear to be the most beneficial for cervical patients with 43% (3 of 7) showing the same 2-grade or better recovery of motor and sensory function.
"The safety and efficacy observations of the Cethrin trial continue to be encouraging. Many patients have shown a degree of improvement far above the expected outcome," commented Dr. Mark Hurtt, Alseres' Chief Medical Officer. "The interim results of the Phase I/IIa study have helped identify what we believe will be the most effective dose range to carry into our Phase IIb trial later this year."
Based on these results, Alseres intends to move forward with its previously announced plans for the Cethrin Phase IIb trial in acute spinal cord injury in the second half of 2008. This trial will be a double-blind, randomized, placebo-controlled, multi-center, Phase IIb trial in up to 100 patients with acute cervical SCI at up to 80 sites in the United States, Canada, Europe and other selected countries.
A total of 48 patients with acute SCI were enrolled in the Phase I/IIa open label study at nine sites across Canada and the United States. An escalating dose of Cethrin (0.3, 1, 3, 6 or 9 mg) was administered to the injured spinal cord during spinal decompression surgery. Neurological outcomes were measured using the ASIA Impairment Scale, or AIS. Evaluations were completed at 0, 1.5, 3, 6 and 12 months after treatment. Only patients who suffered a complete thoracic or cervical SCI (classified as grade A on the ASIA Impairment Scale) were enrolled in the trial.
The ASIA Impairment Scale is used to grade patients 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. Patients classified as AIS C have regained sensory and partial motor function and those classified as D often regain the ability to walk with assistance. A component of this scale is the assessment of change in Motor Score. The measurement is made by assessing five muscle groups in each arm and leg on a 0-5 point scale for a total of 100 motor points. Using this assessment, the total change in motor function can be measured. The Clinical Guidelines Panel Report issued by the International Campaign for Cures of spinal cord injury Paralysis, or ICCP, indicates that a cervical, AIS A-injured patient is likely to improve 10 ASIA motor points during the first year after SCI.
The following outcomes were demonstrated in the 12-month interim data on the first 37 acute spinal cord injury patients who received doses up to 6 mg:
-- There were no serious adverse events related to Cethrin.
-- The data from 6 and 12 months showed 38% (5 of 13) of cervical injury
patients showed a 2-grade or better AIS grade improvement.
-- Subgroup analysis appears to indicate a dose related response in the cervical patient group with 43% (3 of 7) of the cervical patients from the 1 and 3 mg dose groups demonstrating improvement of at least 2 AIS grades. Two of these three patients improved 3 levels from AIS grade A to AIS grade D.
-- Subgroup analysis of 12-month mean motor score changes showed improvement in both the 1 and 3 mg dosage groups in the cervical-injured patients with mean motor score changes of 16.3 points in the 1 mg and 27.3 points in the 3 mg doses.
-- Analysis of individual dose groups over time using both ASIA Impairment Scale grade and ASIA Motor Score changes suggest that the most effective Cethrin doses are 1 and 3 mg for cervical patients.
Patients in the cervical and thoracic 9 mg dose cohort are still being assessed and their data will be reported when it is available.
About Cethrin(R)
Cethrin is a recombinant protein drug that is being investigated for its potential to restore motor and sensory function after spinal cord injury. 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 Alseres Pharmaceuticals, Inc.
Alseres Pharmaceuticals, Inc. (ALSE) is engaged in the development of therapeutic and diagnostic products primarily for disorders in the central nervous system (CNS). The Company maintains a world-class intellectual property position in the field of regenerative therapeutics. The Company's energy and focus is reflected in several important initiatives. Cethrin, a recombinant-protein-based drug designed to promote nerve repair after acute spinal cord injury, demonstrated positive interim results in a Phase I/IIa clinical trial. The Company's research and pre-clinical programs include, Inosine for the treatment of spinal cord injury and stroke, Oncomodulin for the treatment of ocular injury and disease and research programs directed at a number of regenerative therapies including bone repair. The Company has a robust molecular imaging development program targeting diagnosis of Parkinson's disease and potentially dementia. The Company's lead molecular imaging product candidate is Altropane which is in Phase III clinical trials for the diagnosis of Parkinsonian Syndromes including Parkinson's Disease. The Company has research collaborations with Harvard Medical School and Children's Hospital Boston.
SOURCE: Alseres Pharmaceuticals, Inc. |
