Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Monday October 26, 1998
Forty-three individuals were randomly assigned to two groups, each of which received four weeks of treatment with HAART. For the remainder of the study, one group received HAART plus REMUNE while the other group received HAART plus an adjuvant (placebo). Consistent with interim 20 week results presented in July at the 12th Worlds Aids Conference in Geneva, Switzerland, at 32 weeks the group receiving HAART plus REMUNE had significantly higher lymphocyte proliferative responses to native p24 (p=0.0002), gp120-depleted HIV-1 (p=0.0005), and whole BaL HIV (p=0.007) antigens, while the group receiving HAART plus placebo did not develop significantly higher lymphocyte proliferative responses. These results continue to suggest that REMUNE may significantly enhance an HIV-1 specific immune response to the strain of the virus most commonly found in the U.S. (BaL-Clade B).
The HAART plus REMUNE treated group also experienced significant increases in production of MIP-1 beta, a beta-chemokine associated with viral load suppression, (p=0.007) and skin test reactivity to HIV antigens, (p=0.006) compared to the HAART plus placebo group. In addition, 87% (13/15) of subjects receiving HAART plus REMUNE reached HIV plasma RNA levels of "<1 copy/ml" (OD=background) at 32 weeks compared to 50% (6/12) of those receiving HAART plus placebo (p=0.09).
The Company believes that REMUNE may stimulate the immune system against the virus and also may stimulate specific antiviral substances, such as chemokines, which are produced by the immune system and may naturally protect T cells from HIV infection. By utilizing an immune-based therapy such as REMUNE, it may be possible to augment the natural immune system against the virus and further optimize the effects of antiviral drug therapy.
In clinical trials conducted to date with REMUNE, with or without antiviral drug therapy, the most frequently reported side effects include local transient pain, soreness and redness at the site of injection, muscle aches, fatigue and headache.
REMUNE is an immune-based therapy currently in development by The Immune Response Corporation and Agouron Pharmaceuticals, Inc. for the treatment of HIV infection.
The Immune Response Corporation is a biopharmaceutical company based in Carlsbad, California, developing immune-based therapies to induce specific T cell responses for the treatment of HIV, autoimmune diseases and cancer. The Company is conducting clinical trials for its immune-based therapies for HIV, rheumatoid arthritis, psoriasis, multiple sclerosis, colon cancer and brain cancer and preclinical studies for melanoma and prostate cancers. In addition, the Company is developing a targeted delivery technology for gene therapy which is designed to enable the intravenous injection of genes for delivery directly to the liver. The Company's gene therapy program is currently focused on diseases of the liver and is in preclinical studies for the treatment of hemophilia and hepatitis.
NOTE: The Immune Response Corporation news releases are available at no charge through the company's automated attendant 800 number at 800-491-0153. News releases are also available 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 materially from those expected due to a variety of risk factors, including whether these results will be predictive of clinical outcomes, the uncertainty of successful completion of clinical trials of REMUNE(TM), and those risks 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, 1997. 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.
SOURCE: The Immune Response Corporation
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