A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination

Sponsor:

Brief Summary:

Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study
of NeuroVax™ vs. Incomplete Freund’s Adjuvant ( I F A) placebo. 150 subjects with Secondary
Progressive SPMS.

Criteria

Inclusion Criteria:

– Ages Eligible for Study: 18 Years to 70 Years

– Genders Eligible for Study: Both

– Accepts Healthy Volunteers: No Criteria

– Subject is between 18 and 70 years of age, inclusive.

– Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary
Progressive course.

– Expanded Disability Status Scale (EDSS) >=score 3.5 (Appendix B).

– Two or more documented clinical relapses of MS in the preceding 24 months OR one
documented clinical relapse of MS in the preceding 1 2 months prior to screening .

– Laboratory values within the following limits:

– Creatinine 1 . 5 x high normal.

– Hemoglobin

Exclusion Criteria:

– Subjects currently prescribed Campath or Lemtrada

Locations

CRO, San Diego, California, United States, 92129