The Immune Response Corporation Announces New Phase II NeuroVax Study;

    Business Editors/Health/Medical Writers
    BIOWIRE2K

    CARLSBAD, Calif.--(BUSINESS WIRE)--March 1, 2005--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 a new Phase II study to investigate the long-term safety, mechanism-of-action, and utility of a quarterly dosing regimen of NeuroVax(TM), an investigational T-cell receptor (TCR) peptide vaccine for multiple sclerosis. NeuroVax(TM) is an immune-based therapy designed to specifically down-regulate the body's destructive immune responses observed in MS patients to alleviate the impact of the disease.
    "The NeuroVax(TM) data we've seen thus far lead us to believe that it may have a clinical benefit for MS patients and we are excited to begin this new Phase II study to provide additional important information about the therapy's mechanism-of-action and long-term safety," said John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation.
    Last year, the Company presented data demonstrating that NeuroVax(TM) produced a peptide-specific immune response in 94 percent of the patients treated in a Phase I/II clinical trial in MS. A separate open-label rollover study has now completed enrollment and is currently following those patients to evaluate the long-term safety of NeuroVax(TM). The new Phase II study announced today will build on the knowledge acquired in these studies and seek to further understand the mechanism-of-action of NeuroVax(TM) and explore possible dosing regimens.
    "This new Phase II study is designed to examine the durability of the immunological responses we've seen in patients receiving NeuroVax(TM)," said Georgia Theofan, Ph.D., Vice President of Clinical Development at The Immune Response Corporation. "We may be able to successfully maintain these responses with a quarterly dosing regimen which would be an important benefit to patients."
    The new open-label study will ultimately enroll 40 patients with relapsing remitting or secondary progressive multiple sclerosis, of which approximately 30 will be rollover patients from a previous study. Patients in this new study will receive three monthly NeuroVax(TM) injections followed by three quarterly injections. Enrollment is expected to be completed by spring 2005 and results are expected in 2006.
    The Company's strategy for the development of NeuroVax(TM) includes not only the expansion and completion of the current and new Phase II trials, but also the initiation in summer 2005 of a large placebo controlled trial designed with magnetic resonance imaging (MRI) and clinical endpoints to examine the clinical benefit of NeuroVax(TM). The Company also intends to search for a corporate partner to help take this program to commercialization.
    NeuroVax(TM) is composed of a mixture of three T Cell Receptor (TCR) peptides selected to represent three over-expressed TCR families in MS patients (BV5S2, BV6S5, and BV13S1) combined with an adjuvant to improve immune response rates. While the first completed controlled study was not designed to evaluate clinical benefit, the investigators observed a trend favoring decreased MRI activity, an important diagnostic marker for MS, among patients who responded to NeuroVax(TM) immunologically.

    About Multiple Sclerosis and NeuroVax(TM)

    Multiple sclerosis (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, T-cells that then attack the myelin and are largely responsible for disease progression. The Company postulates that a vaccine 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 reaction.

    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 multiple sclerosis (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 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, 2003, and its subsequent Quarterly Reports 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.

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CONTACT: The Immune Response Corporation Michael K. Green, 760-431-7080 (Investors) info@imnr.com or Sam Brown Inc. Corporate Communication Laura Silver, 310-551-9940 (Media) silver@sambrown.com

KEYWORD: CALIFORNIA INDUSTRY KEYWORD: PHARMACEUTICAL BIOTECHNOLOGY MEDICAL PRODUCT SOURCE: The Immune Response Corporation

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