Tuesday November 14, 7:02 am Eastern Time
SOURCE: The Immune Response Corporation
CARLSBAD, Calif., Nov. 14 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR - news) 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."
The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific immune responses for the treatment of HIV, autoimmune diseases, and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection.
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This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including the uncertainty of successful completion of clinical trials, and those risks set forth from time to time in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 1999 and subsequent Forms 10-Q. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
SOURCE: The Immune Response Corporation