November 2005
COPAXONEŽ may repair nerve damage in MS patients
KANSAS CITY, Mo. (November 15, 2005) -- Clinical research data published in the December issue of Multiple Sclerosis provided evidence that COPAXONEŽ (glatiramer acetate injection) may offer protection from axonal injury and induced neuronal metabolic recovery in patients with relapsing remitting multiple sclerosis (RRMS).
In a pilot study of 18 RRMS patients using brain imaging techniques, COPAXONEŽ was found to produce significant increases in n-acetylaspartate/creatine (NAA/Cr) ratio, an indicator of neuron and axon integrity, compared to four untreated control patients after one year of treatment. This increase was maintained at two years of follow-up. Additionally, patients treated with COPAXONEŽ showed a significant 50 percent reduction in relapses compared to baseline (p<0.001) while relapse rate in the untreated group remained unchanged.
"The increases in NAA/Cr ratios with COPAXONEŽ suggested sustained beneficial effects on cerebral axonal recovery. We believe this indicates a potential for improved electrical conduction pathways in the brain, supporting the emerging concept that, centrally, COPAXONEŽ may be acting as a neuroprotective agent," said Omar Khan, M.D., associate professor of neurology and director of experimental therapeutics/clinical research, Multiple Sclerosis Center, Wayne State University. "This data is of critical significance because axonal transection is a well-known feature of active MS lesions and represents an irreversible stage of the disease process," said Dr. Khan.
Twenty-two treatment-naďve RRMS patients were included in the study. Baseline neurological assessments and magnetic resonance spectroscopy imaging (MRSI) scans were performed. Eighteen patients were treated with COPAXONEŽ (glatiramer acetate injection) and followed for two years with neurological assessments every six months and MRSI scans annually. Due to needle phobia, four patients elected to remain untreated and were followed using the same assessment and MRSI schedule. NAA/Cr ratio measurements were obtained in a selected volume of interest (VOI) within the brain and included normal-appearing white matter (NAWM) within the VOI.
In the COPAXONEŽ group, the NAA/Cr levels within the VOI were significantly increased by 9.1 percent at year one and by 10.7 percent at year two, compared to baseline (p=0.03 for both assessments). Conversely, in the untreated group, a 5.5 percent decrease in NAA/Cr levels was observed in the VOI at year one (p=0.04) and an 8.9 percent decrease at year two (p=0.03). COPAXONEŽ patients also demonstrated a 5.4 percent and 7.1 percent increase in NAA/Cr ratios within the NAWM at years one and two, respectively (p=0.04 for both). Untreated patients had a two percent (p=n.s.) and 8.2 percent (p=0.03) decrease in NAA/Cr ratios within the NAWM at year one and two, respectively.
"We recognize our study contains limitations, such as the number of patients, open-label design, and the MRS technique of evaluating NAA levels," stated Dr. Khan. "However, our recently presented three-year data showed sustained improvements in NAA/Cr ratios which clearly demonstrated a long-term clinical benefit and showed that COPAXONEŽ treatment may lead to neuronal recovery," said Dr. Khan.
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About COPAXONEŽ
Current data suggest COPAXONEŽ (glatiramer acetate injection) is a selective MHC class II modulator. COPAXONEŽ is indicated for the reduction of the frequency of relapses in relapsing remitting multiple sclerosis. The most common side effects of COPAXONEŽ are redness, pain, swelling, itching, or a lump at the site of injection, weakness, infection, pain, nausea, joint pain, anxiety, and muscle stiffness.
COPAXONEŽ Demonstrated Protection
COPAXONEŽ is now approved in 44 countries worldwide, including the United States, Canada, Mexico, Australia, Israel, and all European countries. In Europe, COPAXONEŽ is marketed by Teva Pharmaceutical Industries Ltd. and sanofi-aventis. In North America, COPAXONEŽ is marketed by Teva Neuroscience. Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies in the world. Close to 90 percent of Teva's sales are in North America and Europe. The company develops, manufactures, and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system. Teva Pharmaceuticals USA and Teva Neuroscience, Inc. are subsidiaries of Teva Pharmaceutical Industries Ltd. Teva Neuroscience, Inc. markets COPAXONEŽ. COPAXONEŽ is a registered trademark of Teva Pharmaceutical Industries Ltd.
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