Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple Sclerosis

Exclusion Criteria

• •1. Diagnosis of Secondary Progressive MS, Primary Progressive MS or Progressive Relapsing MS.
• •2. Normal baseline brain MRI.
• •3. History of any clinically significant autoimmune disease: inflammatory bowel disease, diabetes, lupus or severe asthma.
• •4. Current or prior malignancies (excluding non-melanoma skin carcinoma or in situ carcinoma of the cervix that has been adequately treated.)
• •5. Significant organ dysfunction, including cardiac, renal (eGFR ≤ 60 ml/min.), liver, central nervous system, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dL; ALT or AST ≥ 1.5x the upper limit of normal), history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to enrollment.
• •6. Steroid therapy within 60 days prior to enrollment, with the exception of corticosteroids or ACTH for relapse treatment during the course of the study.
• •7. Known allergy to Gadolinium-DTPA
• •8. Therapy with any immunomodulatory drugs within 3 months prior to enrollment, including but not limited to interferons, glatiramir acetate, BG-12, teriflunomide, laquinimod and IV immunoglobulin.
• •9. Treatment at any time with immunosuppressive drugs such as cladribine, total lymphoid irradiation, monoclonal antibody treatment, mitoxantrone, Tysabri, fingolimod, cytoxan, methotrexate.
• •10. Participation in any investigational therapy within one year prior to enrollment, unless given approval by PI.
• •11. Known or suspected current or past alcohol or drug abuse within one year prior to enrollment.
• •12. Any medical, psychiatric or other condition that could result in a subject not being able to comply with protocol requirements.