Teitelbaum R Arnon and M Sela Weizmann Institute of Science Rehovot Israel 2007 Elsevier Ltd All Rights Reserved

8.14.1 Introduction 173

8.14.2 Preclinical Studies 174 The Beginning 174 The Chemistry of Copaxone 175 Studies in Experimental Animal Models 175

8.14.3 Clinical Investigations 175 Early Clinical Trials 176 Clinical Studies Leading to Food and Drug Administration Approval 176 Bornstein study 176 Phase III studies 176 Recent Clinical Studies 176 Open-label extension of the American phase III trial 176 Meta-analysis of the double-blind, placebo-controlled clinical trials 177 Magnetic resonance imaging studies 178 Study of primary progressive multiple sclerosis 178 Oral study 178 Comparative studies 178 Safety and Tolerability 179

8.14.4 The Immunopharmacology of Glatiramer Acetate 179 Immunological Properties of Glatiramer Acetate 179 Binding to major histocompatibility complex molecules 179 Inhibition of T-cell responses by glatiramer acetate 179 Induction of antigen-specific T-regulatory cells 179 Effect of glatiramer acetate on antigen-presenting cells 180 Neuroprotective effects of glatiramer acetate 180 Immunological Effects of Glatiramer Acetate in Multiple Sclerosis Patients 181 Antibody response 181 T-cell response to glatiramer acetate in naive multiple sclerosis patients 181 T-cell response to glatiramer acetate in treated multiple sclerosis patients 181 Proposed mechanism of action of glatiramer acetate-specific immunomodulation 182

8.14.5 Concluding Remarks 182 References 183

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