AEGiS-PRn: Data Safety Monitoring Board Recommends Completion of a Phase II Remune Trial in Spain of Patients Infected With HIV PRNewswireImportant note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
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Data Safety Monitoring Board Recommends Completion of a Phase II Remune Trial in Spain of Patients Infected With HIV

PRNewswire - November 4, 1999


CARLSBAD, Calif., Nov. 4 /PRNewswire/ -- The Immune Response Corporation (Nasdaq: IMNR) today announced that an independent Data Safety Monitoring Board (DSMB) composed of European and U.S. scientists recommended that the trial in Spain of Remune(TM) (trial 2102) in patients infected with HIV continue to its conclusion. This decision followed review of efficacy data from the trial concerning viral load (the amount of HIV detected in the blood) and CD4 helper T-cell counts (immune cells selectively destroyed by HIV).

Professor Edwardo Fernandez-Cruz, Head of the Division of Clinical Immunology at University General Hospital "Gregorio Maranon" in Madrid, and Principal Investigator of the Spain trial commented, "We are encouraged by evidence of the development of strong immune responses specifically against HIV, including helper T-cell proliferation and cytotoxic T-cell activity." T-cells are believed to play an important role in controlling HIV infection, Professor Fernandez-Cruz explained, because other researchers have noted an association of strong T-cell immune responses in individuals who are infected with HIV but remain AIDS-free for long periods of time (long-term nonprogressors). It has become clear that treatment with antiretroviral drugs alone may not prevent the rebound of HIV in some chronically infected patients, and stimulation of the immune system specifically against HIV may be a key to the long term control of HIV replication, Professor Fernandez-Cruz added. Professor Fernandez-Cruz presented immunological data from the trial (which will remain blinded until its conclusion) at The 4th International Symposium of AIDS in Madrid, Spain, November 4-5, 1999.

"Given the DSMB's decision to continue the trial to completion, we are hopeful that this trial will indicate that Remune has clinical utility," said Dennis J. Carlo, Ph.D., President and CEO of The Immune Response Corporation. "This trial is examining the effects of Remune added to antiretroviral therapy on preventing treatment failure in chronically infected individuals. The Company believes that while antiviral drugs interrupt the reproduction process of HIV within infected cells, Remune may stimulate the immune system to destroy HIV-infected cells, an ability that is lost soon after infection with HIV," added Dr. Carlo.

The Remune (2102) study in Spain is a double blind placebo-controlled trial which enrolled 242 HIV infected patients not taking antiretroviral drugs (ARTs) prior to time of enrollment. The efficacy of Remune administered in combination with ARTs will be assessed by comparing the time to increases in viral load (above 5000 copies/mL) and decreases in CD4 helper 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 proliferation, chemokine and cytokine production (antiviral messengers of the immune system) and cytotoxic T-cells (T-cells that kill infected CD4 cells), are also being monitored. The trial, being conducted at 13 clinical centers throughout Spain, is expected to conclude in the latter part of 2000.

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 including a pivotal registration trial launched in September with Agouron Pharmaceuticals, Inc., the Company's partner for development and commercialization of Remune.

The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, focusing on developing immune-based therapies to induce specific T-cell responses for the treatment of HIV and autoimmune diseases. In addition, the Company is working on cancer vaccines and gene therapy.

NOTE: The Immune Response Corporation news releases are available at no charge through PR Newswire's 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 this number 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 this clinical trial or any 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, 1998 and subsequent Forms 10-Q. The Company undertakes no obligation to publicly release the result 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 Immune Response Corporation

CONTACT: Creighton W. Lawhead, Vice President, Head of Commercial Affairs and Investor Relations of The Immune Response Corporation, 760-431-7080/

Web Site: http://www.imnr.com/
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