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Department of Neurology

Tovaxin

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Subcutaneous Tovaxin™ in Subjects with Clinically Isolated Syndrome or Relapsing-Remitting Multiple Sclerosis

Study Duration
Enrollment is scheduled to begin the end of September 2006 and continue until all subjects are enrolled at all sites and continue 62 weeks after the entry of the last subject.

Key Inclusion Criteria

  1. Provides signed, informed consent and is willing to participate in and comply with all study procedures.
  2. Male and female subjects aged 18 to 55 years.
  3. Presence of Myelin Reactive T cells at screening visit
  4. Subjects who have experienced a CIS suggestive of central nervous system demyelination within 12 months of the screening visit and have a positive MRI that fulfills the Barkhof Criteria   
  5. Diagnosis of MS within the past 10 years [according to the McDonald criteria (2005), and with a clinical course consistent with RR-MS as defined by Polman et.al.106 with at least 1 medically documented clinical relapse within the 12 months prior to screening or 2 medically documented relapses within the 24 months prior to screening or at least 1 gadolinium-enhancing lesion consistent with MS on the screening MRI. The interval between the relapse and screening is to start at the time of relapse onset. A relapse is defined as objective neurological signs and/or symptoms documented in the medical record and of at least 24 hours duration and determined by the investigator or the treating physician as consistent with an MS relapse.
  6. Screening and baseline EDSS score between 0.0 and 5.5, inclusive.

Key Exclusion Criteria

  1. Unable to produce MRTC line.
  2. Ongoing, disease-modifying treatment for MS during the last 30 days, including cyclosporine, azathioprine, methotrexate, subcutaneous or oral glatiramer acetate, interferon beta, intravenous immunoglobulin, plasmapheresis, cytapheresis, cyclophosphamide, natalizumab, and 60 days for mitoxantrone and any prescription corticoidsteroid.
  3. Diagnosis of progressive-relapsing, secondary progressive or primary progressive MS or other serious neurological disease.
  4. Planned pregnancy, currently pregnant or breastfeeding.
  5. Females of childbearing potential who are not using a medically accepted means of contraception
  6. History of cancer, with the exception of treated squamous and basal cell carcinoma of the skin, and cervical carcinoma in situ, unless approved individually by the sponsor.
  7. HIV positive.
  8. A clinically significant infectious illness requiring medical treatment within 30 days prior to randomization.
  9. Medical history of alcohol or substance abuse within the previous 2 years (i.e. illegal drugs, prescription and over-the-counter medications causing significant emotional, physical and social  problems) requiring medical treatment.
  10. Participation in any other investigational study within 30 days prior to randomization.
  11. Any prior treatment with total lymphoid irradiation, cladribine, T-cell, or T-cell receptor vaccination.
  12. Any other significant medical condition that, in the opinion of the investigator, would significantly decrease study compliance, jeopardize the safety of the subject, or affect the validity of the trial results.
  13. If a subject has a relapse between Screening and Baseline, the subject must complete a new Screening visit at least 8 weeks after the disease has stabilized.

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