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Treatment with Copaxone Plus Minocycline Showed Substantial,Reduction of Disease Activity in Patients with Active,Relapsing-Remitting Multiple Sclerosis

ublished in the Journal of Neuroimmunology indicated that the combination of minocycline and COPAXONE(r) decreased neuron-inflammation, axonal loss and demyelination in an animal model of MS.

"COPAXONE(r) is one of the most frequently used RRMS therapies due to its proven efficacy and safety and unique presumed mechanism of action," said Metz. "In previous studies, COPAXONE(r) has shown efficacy and safety both in combination with intravenous steroids and after induction

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GA Minocycline/Page 2

with the immunosuppressant mitoxantrone; its compatibility with other compounds may make it unique among the disease modifying class of drugs and a treatment of interest for the future study of combination therapies for MS," Metz added.

About the Study

This double-blind, randomized study evaluated the safety, tolerability and efficacy of the combination of COPAXONE(r) plus oral minocycline in the treatment of RRMS patients with active disease.

Patients in this study (n=44) with one or more T1-enhancing lesions on their screening MRI were randomized to receive either COPAXONE(r) 20 mg daily plus minocycline 100 mg twice daily or COPAXONE(r) plus placebo for nine months. Patients were assessed clinically and by MRI scans at screening and months 1, 3, 8 and 9. The primary outcome was the total number of T1-enhancing lesions at months 8 and 9.

Forty patients completed the study. Groups were balanced at baseline except for greater T1-enhancing lesion number in the COPAXONE(r) plus minocycline group (median 3 versus 2; mean 7.62 versus 2.43 (p=0.07)). Despite this imbalance, treatment trended toward significance in the COPAXONE(r) plus minocycline group. At months 8 and 9, the number of T1-enhancing lesions was reduced by 63 percent (mean 1.47 versus 2.95; p=0.08) and the number of new T2 lesions was reduced by 65 percent (mean 1.84 versus 5.14; p=0.06), compared to COPAXONE(r) alone. Relapse risk rate was also non-signif
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