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The Immune Response Corporation Announces REMUNE(R) Restores HIV-1-Specific Activity of CD4+ and CD8+ T Cells, Similar to Anti-HIV Immune Responses Seen in Long-Term Nonprogressors

 - Results Published in September Issue of Journal of Experimental Medicine -

    CARLSBAD, Calif., Sept. 28 /PRNewswire-FirstCall/ -- An investigational
treatment called REMUNE(R) (HIV-1 Immunogen) appears to boost both
HIV-1-specific CD4+ and HIV-1-specific CD8+ T cell lymphocyte activity in
chronically HIV-1 infected patients.  The results are published in the
September 20th issue of the Journal of Experimental Medicine (vol 200, pgs.
701-712).
    REMUNE(R) is being developed by The Immune Response Corporation
(Nasdaq: IMNR), a biopharmaceutical company dedicated to becoming a leading
immune-based therapy company in HIV and multiple sclerosis.
    "These results provide additional evidence that REMUNE(R) can induce the
types of immune responses that could potentially show a benefit in delaying
disease progression in HIV-infected subjects," said John N. Bonfiglio, Ph.D.,
Chief Executive Officer of The Immune Response Corporation.  "Ability to
generate both CD4+ and CD8+ HIV-1 specific immune responses is observed in
long-term nonprogressors, who are a small percentage of HIV-positive patients
that are able to live with the HIV virus for extended periods of time without
progressing to AIDS."
    "The ability to emulate this immunologic profile with an HIV therapeutic
vaccine is one of the goals of the ongoing research in this area.  It may be
an important indicator of clinical utility that REMUNE(R) can induce these
responses.  We are continuing to study this important aspect of REMUNE(R),"
continued Dr. Bonfiglio.
    T-lymphocytes include subsets of CD4+ cells and CD8+ cells and play an
important role in the progression of HIV-1 and other viral infections.
However, the interaction between these subsets of cells is poorly understood.
The current study sheds light on this interaction and indicates that restoring
CD4+ T cell responses with REMUNE(R) enhances HIV-1-specific CD8+ T cell
proliferation.
    The researchers led by Marcus Altfeld, M.D., with the Massachusetts
General Hospital and Division of AIDS, Harvard Medical School, recruited
35 HIV-1 infected individuals.  Of those, 18 had recent primary HIV-1
infection; an additional 7 had a long-term non-progressive disease course, and
10 individuals had chronic progressive HIV-1 infection.  HIV-1 specific
responses were evaluated in these individuals, and compared with responses
observed in T cells that had previously been obtained from subjects
participating in a clinical study of REMUNE(R).
    By measuring responses in individuals at different stages of the disease,
the researchers demonstrated that HIV-1-specific CD8+ T cells proliferated
rapidly in acute infection, but lost this ability as viral replication
progressed and was not observed in individuals with chronic infection.  This
response was maintained, however, in individuals with long-term nonprogressive
disease, and appeared to be dependent on interluken-2 (IL-2) secretion by CD4+
T helper cells.
    Samples derived from patients in a previous REMUNE(R) study were similarly
analyzed.  Five patients had received REMUNE(R) and five had received IFA
placebo.  The results showed that both HIV-1-specific CD4+ T cells and CD8+ T
cells proliferated in the REMUNE(R) group but not in the controls.  They also
demonstrated significantly higher HIV-specific IL-2 production by CD4+ T cells
in REMUNE(R) treated individuals than in the controls (p=0.05).  These results
suggest that in vivo augmentation of CD4+ T cell response with REMUNE(R) can
restore HIV-1 specific CD8+ T cell lymphoproliferative immune responses in
vivo via a mechanism involving CD4+ production of IL-2.
    REMUNE(R) is in Phase II development by The Immune Response Corporation
and is not approved by any regulatory agencies in any country at this time.
The authors of this paper have not received research funding support from the
company for this study.  Inquiries related to the paper should be directed to
Marcus Altfeld, M.D., at Massachusetts General Hospital in Boston.

    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 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 http://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.

     MEDIA CONTACT:
     Laura Silver, Sam Brown Inc. Corporate Communications
     310-551-9940
     silver@sambrown.com

     INVESTOR RELATIONS CONTACT:
     Kathy Waller, Financial Relations Board
     312-266-7800
     kwaller@financialrelationsboard.com

     AT THE COMPANY:
     Michael K. Green, Chief Financial Officer
     760-431-7080
     info@imnr.com


SOURCE The Immune Response Corporation




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  • http://www.imnr.com
    CONTACT:
    media, Laura Silver of Sam Brown Inc.
    Corporate Communications, +1-310-551-9940, silver@sambrown.com;
    or investor relations, Kathy Waller of Financial Relations Board,
    +1-312-266-7800, kwaller@financialrelationsboard.com; or Michael
    K. Green, Chief Financial Officer of Immune Response Corporation,
    +1-760-431-7080, info@imnr.com