NeuroVax has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all treated patients. NeuroVax appears to work by enhancing levels of FOXP3+ regulatory T-cells (Treg cells) which may help regulate expression of pathogenic T-cells in MS patients.
“By restoring FOXP3+ Regulatory T-cell functions to levels seen in healthy individuals, NeuroVax may offer a new and highly targeted mechanism to control pathogenic T-cell activity and limit or prevent nerve tissue damage in MS patients,” said Dr Joseph O'Neill, CEO of The Immune Response Corporation.
“Additionally, NeuroVax's once-a-month dosing, attractive side effect profile and ease of manufacture could benefit the millions of MS patients in need of effective and more tolerable treatment options.”
This trial is designed to assess the safety and efficacy of NeuroVax. The primary clinical endpoint of the study is to compare the cumulative number of new gadolinium enhancing lesions, a key marker of MS disease activity, using MRI scans. Secondary objectives include additional MRI measurements, analysis of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety.