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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Sclerosis, Relapsing-Remitting, Clinically Isolated Syndrome

Intervention / Treatment
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* Biological: Tovaxin


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tovaxin, open-label<br>Tovaxin; 30-45 million autologous myelin reactive T cells | Biological: Tovaxin<br>* 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required.<br>* Other names: T Cell Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Changes in Number of Combined Unique Active Lesions on Brain Magnetic Resonance Imaging (MRI) | This extension study was discontinued due to financial constraints of the company. Of the 38 patients dosed, 32 did not complete all 5 doses. Of the 6 patients that completed the 5 doses, 5 patients did not have a Wk 52 MRI and therefore, no efficacy results are summarized as there is no comparison data. | Annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression |  | Annually | 
| Evaluate Changes in Annualized Relapse Rate |  | Annually | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tovaxin, Autologous, T-cell vaccine (TCV)