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

• 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.

Exclusion Criteria:

• High-dose corticosteroids (e.g. >500 mg methylprednisolone or equivalent) within previous month.
• >5 Gd+ lesions on the first Screening MRI.
• Previous vaccine therapy, stem cell transplantation or total lymphoid radiation.
• Glatiramer within previous 12 months.
• Treatment with any statin in the previous 6 months or elevated cholesterol that requires treatment with a statin.
• Pregnant or lactating women.
• Unwilling to use a medically acceptable form of birth control.
• History of positive test for HIV, hepatitis B or hepatitis C.
• Clinically significant ECG abnormalities.
• Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
• Implanted pacemakers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
• History of intolerable adverse events with statin therapy.