Open Label Extension of Prior TERMS Study to Treat Relapsing Forms of Multiple Sclerosis

An Open-Label Extension Study to Evaluate the Safety, Tolerability and Efficacy of Subcutaneous Tovaxin in Subjects Previously Treated in the TERMS Study 2005-00

The purpose of this study is to further evaluate the safety and efficacy of Tovaxin in the treatment of relapsing forms of multiple sclerosis.

The subjects with positive myelin-reactive T cells (MRTC) in their blood during the previous TERMS study will immediately be eligible for Tovaxin production and treatment in this open label extension study. The MRTC negative subjects will be monitored quarterly for safety, MRTC reactivity, paraclinical and clinical effect. Subjects who become MRTC positive during the monitoring phase will then be eligible for Tovaxin production and treatment in this study.

Inclusion Criteria:

• Subjects who completed the TERMS study and received at least 1 study treatment injection
• Signed and dated statement of informed consent

Exclusion Criteria:

• Pregnancy or breastfeeding
• Experienced a serious adverse drug reaction with confirmatory relationship to Tovaxin in the TERMS study.
• Withdrew from TERMS study and did not continue participating in the remaining 52-week core TERMS study assessments.
• Non-compliant with TERMS study.
• Diagnosis of progressive-relapsing, secondary progressive or primary progressive Multiple Sclerosis (MS) while enrolled in the TERMS study.
• Medical, psychiatric or other conditions that compromise the subject's ability to give informed consent, to understand the patient information, to comply with the study protocol, or to complete the study.
• Any significant change in the subject's medical condition after enrollment in the TERMS study which would have lead to his/her exclusion from participation in that study.