27 November 2000
The Immune Response Corporation announced today that it has initiated a Phase I/II clinical trial with its investigational immune-based therapy in multiple sclerosis (MS) to confirm and expand on previous clinical studies. The clinical trial will evaluate T-cell receptor (TCR) peptide vaccines for safety, the ability to increase anti-inflammatory immune responses and changes in neurologic evaluations including MRI (Magnetic Resonance Imaging). The Phase I/II trial will study 60 MS patients over a 24-week period. The trial is designed to determine whether the combination of TCR peptides (BV5S2, BV6S5 and BV13S1) in Incomplete Freunds Adjuvant (IFA) increases the anti-inflammatory immune responses versus the administration of the same TCR peptides in saline. IFA is a general immune stimulant, which is combined with the peptides to increase the immunogenicity of the peptide vaccine. Twenty-five patients will receive intramuscular injections of the three peptides in IFA, 25 patients will receive intradermal injections of the three peptides in saline, and 10 patients will receive IFA alone as the placebo control. Previous studies have investigated individual TCR peptides for vaccination in MS. Results from these studies suggested that vaccination with the peptide vaccine was well tolerated and was associated with increased proliferation of immune cells and a reduction of the T cell population believed to cause MS.