Copaxone® (glatiramer acetate)

Parent company: Teva Neuroscience, Inc.

• Given through daily subcutaneous injections; dosage is 20 mg.
  
  
• Approved for RRMS and CIS.
  
  
• Copaxone has been shown to significantly reduce the annual relapse rate in RRMS and reduce the risk of people with CIS developing clinically definite MS (CDMS) at two years.
  
  
• Copaxone is a synthetic polypeptide that mimics myelin basic protein, a key component of the myelin sheath (the protective covering of the nerves) that is damaged in MS. This therapy appears to decrease immune-system T cells that damage myelin, and may decrease inflammation by favorably shifting the balance among T-cell subtypes as well as by affecting several interleukins. (Interleukins are a type of cytokine, which are small proteins that may stimulate or inhibit the function of other cells.) Copaxone may also induce lymphocytes (immune-system cells produced to fight infection and disease) to produce factors that enhance the survival of cells that produce myelin, and may have a neuroprotective action that prevents damage to axons (nerve fibers).
  
  
• An international European study was conducted to determine whether immediate treatment with Copaxone is better than delayed treatment in preventing conversion to clinically definite MS (CDMS). This study has shown that, over five years, early treatment with Copaxone reduced the risk of converting to CDMS by 41 percent. These results establish the importance of initiating treatment with Copaxone as early as possible to protect patients from the accumulation of disease activity.
  
  
• Primary-relapsing MS (PRMS) is the least common form of MS. This has a disease onset of gradual worsening with subsequent relapses. There has been some debate as to whether it is justified to categorize PRMS separately from primary-progressive MS (PPMS) in terms of clinical course and prognosis. A sub-analysis of the PROMISE study of 943 patients with PPMS (which failed to show that Copaxone was effective in this group), evaluated differences in baseline characteristics and disability progression between patients with PPMS and PRMS. It showed that some PPMS patients will ultimately convert to PRMS. Although the numbers of PRMS patients analyzed in this study were small, the results suggested that disease progression is more rapid in this clinical sub-group.

Combination and Comparative Studies:

• The COMBI Rx trial is still ongoing. It is comparing the combination of Avonex plus Copaxone to Copaxone alone and Avonex alone. No data have as yet been reported.
  
  
• A Phase II trial to study the effect of combining Copaxone and estriol (a naturally-occurring estrogen hormone) in RRMS on relapse rate is continuing. The study will evaluate relapse rate, severity of relapses, and changes in the EDSS. If successful, this clinical trial could lay the groundwork for a larger, more definitive trial that might lead to a new oral treatment option for women with MS. A pilot trial was encouraging.