Friday, April 07, 2006

The Immune Response Corporation's NeuroVax(TM) Restores FOXP3+ T-Cell Levels Believed to Help in Multiple Sclerosis; Oral Presentation at American Ac


06.04.2006 16:21:00
The Immune Response Corporation (OTCBB:IMNR) announced that its T-cell receptor peptide vaccine candidate, NeuroVax(TM), induces increased FOXP3 expression resulting in re-establishment of normal levels of the FOXP3+ regulatory T-cells believed to be important in controlling the development of multiple sclerosis (MS). Results of the recently completed open-label trial in MS patients were presented yesterday by Dr. Dennis Bourdette, Oregon Health andSciences University (OHSU) Department of Neurology Chair, during an oral presentation at the 58th Annual Meeting of the American Academyof Neurology in San Diego, CA.

"NeuroVax(TM) is a promising candidate for development as a novel vaccine for treating patients with MS," said Dr. Bourdette, who is also a member of the Company's Scientific Advisory Board guiding the development of NeuroVax(TM). "The TCR peptide vaccine works by down-regulating the pathogenic T-cells causing the MS. Our clinical findings indicate that NeuroVax(TM) induces strong, disease-specific immune responses in essentially all the MS patients treated. The findings indicate that an important part of the strong disease-specific immune response induced by NeuroVax(TM) is the stimulation of FOXP3+ regulatory T-cells. This exciting approach could play an important role in the treatment of MS."

About the Study

This one-year open-label trial enrolled 25 patients who received monthly injections of NeuroVax(TM). Seventeen of these were newly-enrolled patients, and showed statistically lower baseline levels of FOXP3+ mRNA measured by RT-PCR (p=0.03) and FOXP3 protein expression by Western blot (p=.02) when compared with healthy controls. Following immunization of these MS patients withNeuroVax(TM), 14/17 patients at 52 weeks demonstrated increased FOXP3+mRNA expression over baseline (p=0.01) and FOXP3 protein expression as a group was also statistically increased over baseline (p=0.02). In a number of patients, FOXP3 message and protein expression became higher than those in healthy controls. These data indicate that a key portion of the strong immune responses induced in patients given NeuroVax(TM) include increases in expression of FOXP3, a marker which is associatedwith the activity of CD4+CD25+ regulatory T-cells. NeuroVax(TM) thus may be boosting an important immune regulatory network which may be clinically beneficial for MS patients.

"These exciting findings on the regulatory mechanism of how NeuroVax(TM) can be influencing the pathogenic T-cells causing MS, coupled with our earlier MRI data that suggest NeuroVax(TM) may decrease the number of total new Gadolinium enhancing lesions, are the basis for the design of a Phase II study that will be initiated later this year in Eastern Europe and the United States that will test the clinical benefit of NeuroVax(TM) by assessing its effect on MRI and relapse rates," commented Dr. Joseph O'Neill, President and Chief Executive Officer of The Immune Response Corporation.

About Multiple Sclerosis

MS is an autoimmune disease in which the immune system mistakenly attacks normal tissues of the central nervous system. It afflicts approximately 400,000 people in the United States and more than 2.5million worldwide (source: National MS Society). The disease is caused by activation of a specific subset of the patient's own white bloodcells, pathogenic T-cells, which then attack a fatty tissue called myelin that surrounds and protects nerve fibers and creates 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.

Autoimmune diseases such as MS may result from the failure of normal immune regulatory mechanisms to prevent proliferation of pathogenic T-cells. Specifically, The Immune Response Corporation'sresearch indicates that MS patients have diminished levels of FOXP3 message and protein expression levels in peripheral T-cells. Thisobservation is the first to link a defect in functional peripheral immunoregulation to an established genetic marker, FOXP3, which previously has been shown to be involved in maintaining immune tolerance and repressing the development of autoimmune diseases such as MS.

About The Immune Response Corporation

The Immune Response Corporation (OTCBB:IMNR) is animmuno-pharmaceutical company focused on developing products to treat autoimmune and infectious diseases. The Company's lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment ofMS and IR103 for the treatment of HIV infection. Both of these therapies are in Phase II clinical development and are designed to stimulate pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.

NeuroVax(TM), which is based on the Company's patented T-cellreceptor (TCR) peptide technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax(TM) has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all patients treated and appears to work by enhancing levels of FOXP3+Treg cells that are able to down-regulate the activity of pathogenicT-cells that cause MS. Increasing scientific findings have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoidarthritis (RA), psoriasis and Crohn's disease. In addition to MS, the Company has open Investigational New Drug Applications (IND) with the FDA for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.

IR103 is based on the Company's patented whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE(R), the Company's first generation HIV product candidate. IR103 is a more potent formulation that combines its whole-inactivated antigen with asynthetic Toll-like receptor (TLR-9) agonist to create enhanced HIV-specific immune responses. The Company is currently testing IR103in two Phase II clinical studies as a first-line treatment for drug-naive HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines.

NeuroVax(TM) and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time. Please visit The Immune ResponseCorporation at www.imnr.com for more information.

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 avariety 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 its product candidates, 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 its product candidates 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 its product candidates in preclinical trials and/or earlier clinical trials. A more extensive set of risks is set forth in The ImmuneResponse Corporation's SEC filings including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2005. TheCompany 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.

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

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