A Phase II Study of NeuroVax™, a Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Sponsor:
Immune Response BioPharma, Inc.
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. 200 subjects with Secondary
Progressive SPMS
of NeuroVax™ vs. Incomplete Freund’s Adjuvant ( I F A) placebo. 200 subjects with Secondary
Progressive SPMS
Criteria
Inclusion Criteria:
– Subject is between 18 and 50 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
Locations
- CRO, San Diego, California, United States, 92129
