AEGiS-PRn: Spanish Health Ministry To Conduct Trial/Treat HIV

Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.

Spanish Health Ministry To Conduct Trial/Treat HIV

PR Newswire, 810 Seventh Avenue, New York, NY 10019 - Thursday, 31 October 1996

CARLSBAD, Calif., Oct. 31 /PRNewswire/ -- The Immune Response Corporation announced today that the Ministry of Health of the Autonomous Government of Madrid, Spain will be conducting a Phase II combination therapy clinical trial using REMUNE and antiviral drugs for the treatment of HIV infection. The three year Phase II trial will be double-blind, adjuvant- controlled and involve up to 300 HIV-infected individuals with CD4 cell counts between 300-500.

The Immune Response Corporation will provide REMUNE, and the antivirals, zidovudine ("AZT") and didanosine ("ddI"), will be provided by the clinical sites where the trial is being conducted. Thirteen clinical centers from Barcelona, Madrid, Murcia, Ovieda and Sevilla are expected to participate in this clinical trial, with Dr. Eduardo Fernandez-Cruz, from the Hospital General Universitario Gregorio Maranon in Madrid, as the principal investigator.

Since AIDS is a virus induced immune suppression, this trial is designed to determine whether the combination of REMUNE and AZT plus ddI will act synergistically (e.g. AZT and ddI lowering viral load and REMUNE boosting the immune system). Therefore, the primary goal of this combination approach is to prolong the impact of AZT/ddI on viral load by increasing the immune response to HIV-infected cells. If successful, a delay in drug resistance and a prolonged duration of low levels of virus in the blood coupled with an increase in the immune response to HIV could translate into clinical benefit. This clinical trial will consist of two separate arms: (i) AZT and ddI alone, and (ii) REMUNE used with AZT and ddI.

"This clinical trial may enable Spain to further enhance its fight against HIV and AIDS while offering HIV-infected individuals an expanded course of therapy. We are hopeful that by using REMUNE in combination with these antiviral drugs an HIV-infected individual's immune system will be able to slow the progression of the disease, and also may delay the resistance often developed to the antiviral therapies," said Dennis J. Carlo, Ph.D., president and chief executive officer of The Immune Response Corporation.

The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, with technologies in four core areas: HIV, autoimmune disease, gene therapy and cancer. The company is conducting clinical trials using immune-based therapies for HIV, psoriasis, rheumatoid arthritis, multiple sclerosis and colon cancer, and preclinical studies for brain and prostate cancers. The company is also developing gene therapy treatments for cardiovascular disease, hemophilia and hepatitis.

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 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 from those expected due to a variety of risk factors, including the uncertainty of successful completion of preclinical and clinical trials, set forth from time to time 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, 1995. 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.

Keywords: HIV; CLINICAL TRIAL; CD4; AZT; IMMUNE SYSTEM; IMMUNE BASED; HEPATITIS

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