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

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.

Study Overview

• Status: Terminated
• Conditions: Clinically Isolated Syndrome; Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Biological: Tovaxin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Cullman, Alabama, United States, 35058
      • North Central Neurology Associates, PC
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Hope Research Institute
    • Phoenix, Arizona, United States, 85013
      • Xenoscience - 21st Century Neurology
  • California
    • Berkeley, California, United States, 94705
      • Alta Bates Summit Medical Center - East Bay Physicians Medical Group
  • Colorado
    • Colorado Springs, Colorado, United States, 80919
      • Patricia A Fodor, PC
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Neurology
    • Pompano Beach, Florida, United States, 33060
      • Neurological Associates
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Medical College of Georgia - Department of Neurology
  • Illinois
    • Northbrook, Illinois, United States, 60062
      • Consultants in Neurology, Ltd.
  • Indiana
    • Fort Wayne, Indiana, United States, 46805
      • Allied Physicians Inc
  • Kansas
    • Lenexa, Kansas, United States, 66214
      • MidAmerica Neuroscience Institute
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Associates in Neurology
  • Michigan
    • Saginaw, Michigan, United States, 48604
      • St Mary's of Michigan - Field Neuroscience Institute
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Ayres & Associates Clinical Trials
  • New York
    • Albany, New York, United States, 12205
      • Upstate Clinical Research, LLC
    • Mineola, New York, United States, 11501
      • Winthrop University Hospital - Clinical Trials Unit
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Neurology Consultants of the Carolinas, PA
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
  • Ohio
    • Akron, Ohio, United States, 44302
      • Neurology & Neuroscience Associates, Inc.
    • Columbus, Ohio, United States, 43221
      • Neurological Research Institute
    • Dayton, Ohio, United States, 45408
      • Neurology Specialists, Inc
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence St. Vincent Medical Center - Northwest MS Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Houston, Texas, United States, 77030
      • The Maxine Mesinger MS Clinic/Baylor College of Medicine
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology
    • San Antonio, Texas, United States, 78229
      • Integra Clinical Research, Llc
  • Washington
    • Kirkland, Washington, United States, 98101
      • MS Center at Evergreen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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	Time Frame
Evaluate Changes in Rate and Severity of Multiple Sclerosis (MS) Progression	Annually
Evaluate Changes in Annualized Relapse Rate	Annually

Collaborators and Investigators

• Sponsor: Opexa Therapeutics, Inc.
• Investigators: Principal Investigator: Edward J Fox, MD, PhD, Central Texas Neurology Consultants

Publications and helpful links

General Publications

• Zhang J. T-cell vaccination in multiple sclerosis: immunoregulatory mechanism and prospects for therapy. Crit Rev Immunol. 2001;21(1-3):41-55.
• Zhang J. T-cell vaccination for autoimmune diseases: immunologic lessons and clinical experience in multiple sclerosis. Expert Rev Vaccines. 2002 Oct;1(3):285-92. doi: 10.1586/14760584.1.3.285.
• Zhang JZ, Rivera VM, Tejada-Simon MV, Yang D, Hong J, Li S, Haykal H, Killian J, Zang YC. T cell vaccination in multiple sclerosis: results of a preliminary study. J Neurol. 2002 Feb;249(2):212-8. doi: 10.1007/pl00007867.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 3, 2008
• First Submitted That Met QC Criteria: January 4, 2008
• First Posted (Estimate): January 16, 2008

Study Record Updates

• Last Update Posted (Estimate): March 15, 2016
• Last Update Submitted That Met QC Criteria: February 16, 2016
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Autologous; Tovaxin; T-cell vaccine (TCV)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 2007-00