The Immune Response Corporation Announces Completion of Remune Studies

    Pharmaceutical Writers/Biotech Writers
    BIOWIRE2K

    CARLSBAD, Calif.--(BUSINESS WIRE)--Jan. 11, 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), announces that the Company has completed two Phase II clinical trials, one in Italy and one in Spain, investigating its lead HIV immune-based therapeutic REMUNE(R) in HIV-positive subjects.
    "With the conclusion of these studies, we are delighted to end the year having met all of our stated REMUNE(R) related milestones," said John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation. "We are currently in the process of auditing and analyzing the data from these two trials. Once finalized, we will submit the data to the FDA as part of ongoing discussions regarding next steps in the REMUNE(R) clinical program. We will also submit for publication in peer-review journals and presentation at scientific conferences."
    The trial in Spain, called REMIT, included 39 patients who had previously received REMUNE(R) in an open label study, who were then randomized to receive blinded REMUNE(R) or Incomplete Freud's Adjuvant (IFA) during REMIT, and a comparative control group of 19 subjects. This trial was designed as an exploratory Phase II trial with multiple endpoints to give the Company more information on the potential role of REMUNE(R) during antiretroviral treatment interruption. All patients interrupted their antiretroviral therapy regimens, and were followed for 48 weeks. Endpoints included time to virologic rebound and time to re-initiate antiretroviral therapy. An independent Data Safety Monitoring Board (DSMB) reviewed the preliminary unblinded results of the study, and concluded that long-term use of REMUNE(R) posed no safety concerns.
    "We are encouraged by the preliminary results of this study, which suggest that long-term exposure to REMUNE(R) may be of benefit in particular subjects. We look forward to the final analysis of the data," said Dr. Louis Aledort, The Mary Weinfeld Professor of Clinical Research at Mount Sinai Hospital, New York, and a member of the DSMB.
    Study IR101-215, a multi-center, randomized study, conducted in Italy, investigated 51 antiretroviral-naive patients over 28 weeks following treatment with REMUNE(R), IFA or saline. Preliminary analysis of the final data suggest that REMUNE(R) can induce HIV-specific T cells that are believed to be important in the control of HIV, and may also stabilize total CD4+ T-cell counts. These results confirm preliminary data that were presented last year. A rollover study to IR103, which combines REMUNE(R) with Amplivax(TM), an immunostimulatory oligonucleotide adjuvant, is planned.
    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.

    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, NeuroVaxTM, 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), NeuroVaxTM 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), NeuroVaxTM 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), NeuroVaxTM 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. Amplivax(TM) is a trademark of Hybridon, Inc.

--30--CB/la*

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

KEYWORD: CALIFORNIA ITALY SPAIN INTERNATIONAL EUROPE INDUSTRY KEYWORD: PHARMACEUTICAL BIOTECHNOLOGY MEDICAL PRODUCT SOURCE: The Immune Response Corporation

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