The Immune Response Corporation Initiates Phase I/II Clinical Trial for
Multiple Sclerosis
Combination Vaccine Targeting Aberrant T Cells to Be Tested for Ability
To Increase Anti-Inflammatory Immune Responses
CARLSBAD, Calif., Nov 14, 2000 /PRNewswire via COMTEX/ -- The Immune Response
Corporation (Nasdaq: IMNR) 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 is a multi-center, three arm, randomized study involving 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 Freund's
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.
T cells are a component of the body's immune system that ordinarily destroy
infected cells, but sometimes go awry and cause an autoimmune disease. MS, which
affects more than one million individuals worldwide, is an example of an
autoimmune disease in which misdirected T cells of the immune system damage the
myelin sheath of the central nervous system. All approved therapies for MS are
only partially effective and often cause side-effects. "There is a real need for
novel treatments for MS that are highly effective and well tolerated," said
Dennis Bourdette, M.D., Oregon Health Sciences University, who will be the
primary investigator for this clinical study.
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.
Arthur Vandenbark, Ph.D., Portland VA Medical Center, co-inventor of the
technology, stated, "By combining three TCR peptides associated with MS, we hope
to target a larger MS patient population, and believe that this will enhance
immunologic and clinical response rates with our therapeutic vaccine approach." |
