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New Data Confirmed Antibodies to Copaxone® Do Not Impact Its Established and Sustained Long-Term Efficacy in Multiple Sclerosis

Jerusalem, Israel, September 28, 2006 - New data presented today at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that antibodies to COPAXONE® (glatiramer acetate injection) developed in all patients with multiple sclerosis (MS) treated with COPAXONE®, but did not interfere with the efficacy of the drug. Over a mean treatment period of more than six years, patients in this cross-sectional study who were continuously treated with COPAXONE® experienced only a minimal increase in their EDSS score, indicating that the long-term efficacy of the drug was not compromised by treatment-related antibodies.
Studies have shown that neutralizing antibodies (Nabs) develop in 5 percent to 45 percent of all MS patients treated with interferon beta (IFN-β). The presence of Nabs to IFN-β may negatively alter the therapeutic effectiveness of this class of disease modifying drugs which includes IFN-β-1a SC (Rebif®), IFN-β-1b SC (Betaseron®), and IFN-β-1a IM (Avonex®). Patients who test positive for NAbs are more likely to have reduced therapeutic benefits from their interferon beta treatment (measured by the reduction in relapse rate, the reduction in disability progression and the disease activity as evidenced by brain magnetic resonance

"Neutralizing antibodies against IFNs are therefore an important issue for MS management, as their development appear to diminish their clinical efficacy," said Professor Dimitrios Karussis, Department of Neurology, Hadassah University Hospital, Ein-Karem, Jerusalem. "Our data confirms that antibodies to COPAXONE® which develop in all patients do not neutralize the drug's biological activity and do not compromise its established sustained long term effectiveness." he added.
Recent guidelines on Nabs to beta interferons, produced by the European Federation of Neurological Societies (EFNS), recommend that all people with MS being treated with IFN-β be screened after 12 and 24 months of treatment to determine the existence of anti-IFN-β Abs, and that those who have persistently high levels of NAbs after re-testing 3-6 months after the first results, should have their interferon beta treatment discontinued. Furthermore, it is recommended that since NABs are cross-reactive, switch from one IFN preparation to another is of no clinical benefit.

About the Study
Patients in this study (n=126) who had received COPAXONE® (glatiramer acetate injection) from 2 years to 15 years were surveyed to determine levels and types of antibodies to COPAXONE® and to correlate these parameters with treatment outcomes. Serum samples were collected from study participants, and were analyzed for the presence of antibodies to COPAXONE® using ELISA E (enzyme-linked immunosorbent assay) methodology. Clinical data, including the current and previous Expanded Disability Status Scale (EDSS) scores, and the relapse rates, were also collected at the time the serum samples were taken.

Over the mean COPAXONE® treatment period of 6.65 years, sera from only six patients demonstrated minimal in vitro neutralizing activity. In addition, patients were clinically stable for the whole COPAXONE® treatment period, showing a minimal mean increase in EDSS score of 0.65 (mean annual increase = 0.10 per patient). Despite mean disease duration of 10.75 years, the majority of patients (77 percent) surveyed had an EDSS score of less than 4.0, a stage at which they were still fully ambulatory.

In order to further study the subject of NABs to IFNs, Teva Neuroscience, Inc., recently initiated the first-ever study designed to....MORE

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