Alseres Pharmaceuticals Announces 12 Month Interim Results from the Phase I/IIa Cethrin(R) Clinical Trial in Acute Spinal C...(ously announced plans for the Cethrin Ph...),Health

Date:5/12/2008

ously 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 patie
'/>"/>

SOURCE Alseres Pharmaceuticals, Inc. Copyright©2008 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5
Related medicine technology :

1. Alseres Pharmaceuticals Enters Agreement to Amend Cethrin(R) License to Lower Milestone Payments and Royalty Rates
2. Alseres Pharmaceuticals Expands Sites for the First Stage of the ALTROPANE(R) Phase III Clinical Trial Program
3. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
4. Alseres Pharmaceuticals Concludes Enrollment in the Cethrin(R) Phase I/IIa Clinical Trial in Acute Spinal Cord Injury
5. Alseres Pharmaceuticals Initiates the ALTROPANE(R) POET-2 Phase III Clinical Trial Program
6. Alseres Pharmaceuticals Announces Expansion of the Cethrin(R) Acute Spinal Cord Injury (SCI) Phase I/IIA Clinical Trial
7. Vion Pharmaceuticals Announces Initiation of Clinical Trial of Cloretazine(R) (VNP40101M) in Combination with Cytarabine
8. Arena Pharmaceuticals, Inc. Announces Initiation of Phase 1 Clinical Trial of Drug Candidate Under Partnership with Taisho Pharmaceutical Co., Ltd.
9. Poniard Pharmaceuticals Completes Enrollment of Phase 2 Picoplatin Trial in Colorectal Cancer
10. Cadence Pharmaceuticals Reports First Quarter 2008 Financial Results and Provides Clinical Program Update
11. Champions Biotechnology and Concordia Pharmaceuticals Complete Service Agreement and Begin Preclinical Evaluation of Oncology Drugs