Immunotherapy With BHT-3009 Alone or Combined With Atorvastatin in Patients With Multiple Sclerosis

Inclusion Criteria

• •Definite diagnosis of multiple sclerosis by the McDonald criteria.
• •Patients with relapsing remitting MS or secondary progressive MS are eligible.
• •1-5 gadolinium enhancing (Gd+) lesions on the first Screening MRI or relapse in the previous 2 years, or disease worsening in the previous 2 years
• •Clinically stable for \> 1 month before screening evaluation and during screening. Patients who are stable on approved therapy are eligible only if they have intolerable side effects or other medical reasons for discontinuing approved therapy.
• •Off interferon for \> 1 month before screening evaluation.
• •Off immunosuppressive and cytotoxic therapy (e.g. mitoxantrone, cladrabine) \>12 months or \> 6 months with CD4 count \> 400.
• •EDSS ≥ 2.5 and \< 7.0.
• •Female or male, age \> 18 years.
• •Able to give informed consent.
• •WBC and platelets in normal range, hemoglobin \> 10.0 g/dl.
• •AST, ALT, bilirubin \< upper limit of normal.
• •Creatinine \< upper limit of normal.
• •CPK \< upper limit of normal.