Open-Label Baseline vs. Treatment Trial Evaluating the Safety, Tolerability and Effect on MRI Lesion and Immunology Parameters of CGP 77116 in Patients With Multiple Sclerosis Mark

This trial will evaluate safety, tolerability and effect on cranial magnetic resonance imaging (MRI) and immune response of CGP 77116 in patients with the demyelinating autoimmune disease, multiple sclerosis (MS). The purpose of the trial is to assess whether CGP 77116 modifies inflammatory disease activity as measured by MRI and immunological techniques, and to facilitate dose selection for future pivotal trials in progressive and relapsing-remitting MS. CGP 77116 is an altered peptide ligand (APL) designed around an immunodominant epitope of human myelin basic protein (MBP) corresponding to amino acids 83-99, for the treatment of multiple sclerosis (MS). Substitution of a key T cell receptor contact residue with alanine results in a non-stimulatory peptide analogue. Recent evidence suggests that a T cell-mediated immune response against immunodominant myelin protein peptides such as MBP (83-99) is involved in MS pathogenesis (1). MS results when the immune system is unable to keep autoreactive T cells from entering the central nervous system where they initiate demyelination of myelin sheaths. By targeting MBP autoreactive T cells, CGP 77116 may downregulate the MBP-specific immune response and lead to amelioration of MS.