Abstract
This review article describes the process which led to the discovery and development of a synthetic amino acid copolymer which we denoted copolymer 1, known now by its brandname Copaxone and generic name glatiramer acetate (GA) for the treatment of relapsing-remitting multiple sclerosis (RRMS). The long road (28 years) from basic scientific research, through studies in the experimental animal model of multiple sclerosis (MS), experimental allergic encephalomyelitis (EAE), to phase I, II, and III clinical trials in MS patients culminating in US Food and Drug Administration (FDA) approval, is unfolded herein.The review also summarizes results from recent clinical trials and studies on the mechanism of action of Copaxone in multiple sclerosis, as well as indications for a therapeutic potential in other autoimmune diseases, graft rejection, and neurodegenerative diseases.Several properties make Copaxone unique: (1) it is the first polymeric drug in which the polymer is the active constituent; (2) it is distinct from the other currently approved drugs for the treatment of RRMS (β-interferons: IFNs) by its specific immunomodulating activity; and (3) it combines in its activity immunomodulating as well as neuroprotective effects. It is a prototype for other autoimmune therapeutic vaccines.The cumulative clinical data demonstrate that Copaxone is effective in reducing the clinical (relapse rate and disability) and magnetic resonance imaging (MRI) activity in patients with RRMS, and that it has a sustained efficacy and tolerability for over 10 years. This, together with its favorable side effects profile, makes Copaxone perceived as a first-line therapeutic option and presently one of the most widely prescribed treatments for patients with RRMS.
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