The Immune Response Corporation (Nasdaq:IMNR), a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and multiple sclerosis (MS), announced today that clinical research conducted by the Company in association with Oregon Health & Science University (OHSU) has indicated that FOXP3, a specific genetic marker on T-cells known to be involved in maintaining immune tolerance and regulation of autoimmune diseases, is significantly reduced in patients with MS compared to healthy controls. These findings, published in the July issue of the Journal of Neuroscience Research, are significant to the Company because this deficiency of FOXP3 in MS patients is likely linked to deficient numbers of regulatory T-cells (also known as Treg cells). The Company believes that induction of these Treg cells is important to the mechanism of action for NeuroVax(TM), the Company's peptide immune-based therapy.

Autoimmune diseases such as MS may result from the failure of tolerance mechanisms to prevent expansion of pathogenic T-cells. This paper establishes that MS patients have abnormalities in FOXP3 message and protein expression levels in peripheral Treg cells. This observation is the first to link a defect in functional peripheral immunoregulation to an established genetic marker, FOXP3, previously shown to be involved in maintaining immune tolerance and preventing development of autoimmune diseases. Diminished FOXP3 levels indicate impaired immunoregulation by Treg cells that may contribute to MS.

"Our research has demonstrated for the first time that MS patients have abnormalities in FOXP3 expression levels. This exciting discovery may allow us to track these cells and determine if immune-based therapies like NeuroVax(TM) can increase the level of Treg cells needed to inhibit inflammation caused by myelin-reactive T-cells thought to cause or worsen MS," said Arthur A. Vandenbark, Ph.D., Senior Research Career Scientist at the VA Medical Center, and Professor of Neurology and Molecular Microbiology and Immunology at Oregon Health & Science University in Portland, Ore., and lead immunologist for this study. "We are continuing our ongoing clinical trials with NeuroVax(TM) and hope that these new findings will help better identify its therapeutic mechanism-of-action."

"Preliminary data obtained in collaborative studies with OHSU indicate that NeuroVax(TM) may indeed induce increased levels of FOXP3 leading to increased production of specific Treg cells which would, in theory, control MS symptoms," said Richard Bartholomew, Ph.D., Executive Director of Research and Development of The Immune Response Corporation. "This important research provides more information about NeuroVax(TM)'s mechanism-of-action and builds upon our earlier studies. It is our strong belief that immune-based therapies, like NeuroVax(TM), can fill a need for safe and effective MS treatments."

The published data was part of a clinical study conducted at OHSU under the Company's FDA-registered investigational new drug (IND) application, and was partially funded by a grant from The Immune Tolerance Network. Blood was obtained from 19 healthy volunteer donors and 19 volunteer MS patients who were enrolled to begin participation in an ongoing open-label clinical trial with NeuroVax(TM). T-cell subpopulations were analyzed for FOXP3 expression by using realtime polymerase chain reaction (PCR) to quantitate FOXP3 message and by Western blots to quantitate FOXP3 protein expression.

About Multiple Sclerosis and NeuroVax(TM)

MS is an autoimmune disease in which the immune system, the body's principal defense against foreign substances such as bacteria, mistakenly attacks normal tissues of the central nervous system. It afflicts approximately 400,000 people in the United States and more than 2.5 million worldwide. Specifically, the disease results in damage to a fatty tissue called myelin that surrounds and protects nerve fibers, creating scarring (sclerosis) that interferes with the normal transmission of nerve impulses. This damage, in turn, leads to a variety of chronic and highly individual and unpredictable neurological symptoms, ranging from movement and balance problems to vision impairment. The disease is largely caused by activation of a specific subset of the patient's own white blood cells, pathogenic T-cells, which then attack the myelin and are largely responsible for disease progression.

The Company postulates that an immune-based therapy containing TCR peptides with Incomplete Freund's Adjuvant (IFA) stimulates regulatory T-cells capable of suppressing these autoreactive pathogenic T-cells. NeuroVax(TM), which combines three TCR peptides with IFA, was designed to increase the likelihood of this immune correction. The Company also intends to search for a corporate partner to help take this program to commercialization.

About OHSU

Oregon Health & Science University, located in Portland, Ore., includes the schools of dentistry, medicine, nursing and science and engineering; OHSU Hospital and Doernbecher Children's Hospital; numerous primary care and specialty clinics; multiple research institutes; and several outreach and community service units.

About The Immune Response Corporation

The Immune Response Corporation (Nasdaq:IMNR) is a biopharmaceutical company dedicated to becoming a leading immune-based therapy company in HIV and MS. The Company's HIV products are based on its patented whole-killed virus technology, co-invented by Company founder Dr. Jonas Salk to stimulate HIV immune responses. REMUNE(R), currently in Phase II clinical trials, is being developed as a first-line treatment for people with early-stage HIV. We have initiated development of a new immune-based therapy, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II clinical trials in Canada and the United Kingdom.

The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVax(TM), which is currently in Phase II clinical trials and has shown potential therapeutic value for this difficult-to-treat disease.

Please visit The Immune Response Corporation at www.imnr.com

This news release contains forward-looking statements. Forward-looking statements are often signaled by forms of words such as should, could, will, might, plan, projection, forecast, expect, guidance, potential and developing. Actual results could vary materially from those expected due to a variety of risk factors, including whether the Company will continue as a going concern and successfully raise proceeds from financing activities sufficient to fund operations and additional clinical trials of REMUNE(R), NeuroVax(TM) or IR103, the uncertainty of successful completion of any such clinical trials, the fact that the Company has not succeeded in commercializing any drug, the risk that REMUNE(R), NeuroVax(TM) or IR103 might not prove to be effective as either a therapeutic or preventive vaccine, whether future trials will be conducted and whether the results of such trials will coincide with the results of REMUNE(R), NeuroVax(TM) or IR103 in preclinical trials and/or earlier clinical trials. These risks, among others, are set forth in The Immune Response Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2004 and its subsequent Quarterly Reports filed on Form 10-Q. The Company undertakes no obligation to update the results of these forward-looking statements to reflect events or circumstances after today or to reflect the occurrence of unanticipated events.

REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.

Source: Business Wire

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