PRNewswire - Tuesday November 21, 2000

The DSMB issued a statement regarding their recommendation: "The DSMB is satisfied with the conduct and analysis of the study." "Based on the results so far, the DSMB feels that the study might yield pivotal information for the (future) development of and application of immunotherapy in HIV-1 infection." The DSMB also indicated that the immunological plausibility of the findings strengthen the data.

The DSMB decided that, "In the interest of solidifying the findings, the DSMB recommends to continue the study, as protocolled, for another 6 months." The DSMB for the Phase II Spain trial is composed of European and U.S. scientists who are experts in HIV/AIDS.

Dr. Eduardo Fernandez-Cruz, Professor of Clinical Immunology at the University General Hospital of Madrid, the Principal Investigator for the trial, commented on the DSMB's recommendation. "The DSMB has reviewed the efficacy data so far in Study STIR-2102 and has recommended completing the study in order to solidify the current findings." In addition, Dr. Cruz stated, "I am hopeful that the significant immunological results observed in STIR-2102, that were previously reported, among other places, at the 13th International AIDS Conference, will confirm the hypothesis that it is possible by immunization with REMUNE (HIV-1 Immunogen) to achieve long term control of HIV-1 virus. These immunological markers include T helper responses, cytokine and chemokine production, and killer T cell activity (CTL)."

The REMUNE study in Spain is a double blind, placebo-controlled trial with 243 patients enrolled with chronic HIV infection. This is the first prospective study to examine the effect of Remune on viral load and CD4 T cells. The efficacy of REMUNE, administered in combination with antiretroviral therapy (ART), will be assessed by comparing the time to increases in viral load and decreases in CD4 T cell counts between patient groups that received ART plus REMUNE or ART plus placebo. Several immunological markers of HIV disease progression, such as T cell helper activity, chemokine and cytokine production (molecules of the immune system which play an antiviral role) and killer T cells (cells that kill infected T cells), are also being monitored to better understand the mechanism of action of REMUNE. The trial is being conducted at 13 major clinical centers throughout Spain.

REMUNE is an immune-based therapy under development that is designed to be used alone or in combination with existing antiviral drug therapies for HIV and is intended to treat HIV-infected individuals and prevent or delay the progression to Acquired Immune Deficiency Syndrome (AIDS). REMUNE is the subject of investigation in several clinical trials with Agouron Pharmaceuticals, Inc. (a Pfizer company), the Company's partner for development and commercialization of REMUNE.

The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific immune responses for the treatment of HIV, autoimmune diseases and cancer. In addition, the Company is developing a targeted non-viral delivery technology for gene therapy, which is designed to enable the delivery of genes directly to the liver via intravenous injection.

NOTE: News releases are available through PR Newswire Company News On-Call fax service. For a menu of available news releases or to retrieve a specific release made by The Immune Response Corporation, please call 800-758-5804, extension 434675. Please retain these numbers for future reference. Company information can also be located on the Internet Web Site: http://www.imnr.com.

This news release contains forward-looking statements. Actual results could vary materially from those expected due to a variety of risk factors, including, but not limited to, whether additional clinical trials will be successfully concluded and whether REMUNE will be approved for marketing or be successfully commercialized. Those factors are discussed more thoroughly in The Immune Response Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended December 31, 1999 and subsequent Forms 10-Q. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

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

SOURCE: The Immune Response Corporation
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