A new, higher dose of Copaxone (glatiramer acetate injection) shows promising results in the treatment of patients with relapsing-remitting multiple sclerosis (RRMS).
A 9-month, randomized, double-blind, parallel-group phase II study of 90 patients comparing a 40 mg dose of Copaxone to the currently approved 20 mg dose showed a 38% greater reduction in mean cumulative number of gadolinium (Gd)-enhancing lesions as measured by magnetic resonance images (MRI) of the brain in patients taking the higher dose compared with those taking the 20 mg dose. In addition, patients taking Copaxone 40 mg experienced a reduced mean on-trial relapse rate of 77% when compared to annual relapse rate prior to entry, as compared to 62% with Copaxone 20 mg, according to a release from Teva.
These study results were announced at this year's 58th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, CA, April 1-8, 2006.
Data from this study demonstrated that Copaxone 40 mg was well-tolerated with a safety profile similar to the currently available 20 mg dose. The efficacy and safety of the approved 20 mg dose of Copaxone have been well established by three pivotal trials and over a decade of experience and clinical research.
"Following these results, we are planning to conduct a large-scale Phase III study designed to confirm the higher efficacy of Copaxone with the increased dose. The Phase III study is expected to be launched in the second half of 2006," said Israel Makov, President and Chief Executive Officer of Teva Pharmaceutical Industries Ltd.