A review of the clinical efficacy profile of copolymer 1: new U.S. phase III trial data.

Copolymer 1 (Copaxone) is a mixture of synthetic peptides composed of four amino acids. It has been shown to alter positively the natural history of multiple sclerosis by both reducing the relapse rate and affecting disability. A recently completed, large-scale, phase III, multicenter, double-blind study confirmed the therapeutic benefit shown in previous pilot studies. Side effects were mild and the daily subcutaneous treatment was well tolerated. Laboratory studies have shown that copolymer 1 prevents or modifies experimental allergic encephalomyelitis in several mammalian species. It induces immunologic suppressor cells, which are deficient in multiple sclerosis, and competitively inhibits the effect of central nervous system myelin antigens, thought to be important in the pathogenesis of multiple sclerosis. Copolymer 1 joins interferon beta in ushering in a new era of well-tolerated treatments for multiple sclerosis.