Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
PRNewswire - November 3, 1999
Lymphocyte proliferation, the replication of T lymphocytes (specialized immune cells) in response to an antigen, is an immunologic marker measured during disease progression as an indicator of immune health.
"This data would appear to support the premise on which REMUNE is based, that improved immune health may lead to the control of HIV infection," said Dr. Ronald Moss, The Immune Response Corporation's executive director of medical and scientific affairs, who presented for the Company at a symposium entitled "Immune-Restoration and Immune-Based Therapies: Implications for Concomitant Therapy and Individualized Patient Care." Viral load, or the amount of HIV RNA in the plasma (cell-free portion of the blood), is a very good indicator of disease progression in the body. "The lower the viral load, the more favorable the prognosis for the patient," Dr. Moss explained. HIV RNA is the genetic material, or the chemical "blueprint," that HIV uses to make more virus.
The data Dr. Moss presented were based on results from a recently concluded 120-week study that involved 2,500 HIV-infected individuals. Patients were allowed to follow any regimen of antiviral therapy and switch antiviral drugs as needed. In a random, pre-selected cohort (n=252), lymphocyte proliferation was significantly higher (p<0.05) for individuals who received Remune plus adjuvant (a general immune stimulant) compared to an adjuvant control group.
Patients infected with HIV typically do not show a lymphocyte proliferative response due to the impairment of their immune system, and are unable to mount an attack against the virus. Following treatment with Remune, the data suggest that lymphocyte proliferative responses specifically against HIV may have been restored in these patients. Furthermore, the observed HIV-specific lymphocyte proliferation was associated with control of the virus measured in the plasma of patients. Viral load was significantly lower (p<0.05) in Remune treated patients compared to the control group at multiple timepoints over the 120-week period. Additionally, there was a significant increase in CD4 cells (p<0.05) in patients treated with Remune.
"The patients in this study were allowed to follow any antiviral drug regimen and switch drugs as often as needed, a situation not typical of most clinical studies in which patients must follow a strictly prescribed regimen. The fact that we still observed significant decreases in viral load for patients treated with Remune against such a background of unrestricted drug therapy is very encouraging in its potential relevance to a real-life clinical situation," Dr. Moss commented.
"We are very pleased with these results that we believe support the scientific validity of REMUNE, our immune-based approach to combating HIV infection," said Dr. Dennis J. Carlo, President and CEO of The Immune Response Corporation. "Our partner, Agouron Pharmaceuticals, Inc., recently initiated a pivotal trial where reduction in a patient's viral load, among other indicators, will help determine REMUNE's efficacy in treating HIV."
The data presented today were derived from a trial discontinued by the Company based on the recommendation of an independent Data Safety Monitoring Board (DSMB). The DSMB made its recommendation believing that the trial would not be able to demonstrate a statistically significant difference in the number of patient deaths between treatment groups (IMNR press release May 17, 1999).
The 2,500 patient trial (Trial 806) was a multicenter, double-blind, Phase III adjuvant-controlled study in subjects with HIV infection and CD4 T lymphocytes between 300 and 549 cells, regardless of concomitant HIV therapies.
The Immune Response Corporation believes that the results reported at this meeting are consistent with the clinical development pathway for Remune which has been developed in collaboration with Agouron Pharmaceuticals, Inc. involving planned or on-going trials to examine the effect of Remune on antiviral drug failures after discontinuation of HAART. Highly active antiviral therapy (HAART) involves the use of antiviral drugs,such as protease inhibitors, that interrupt the reproduction process of HIV within infected cells.
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 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 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 the data presented indicate that Remune is having an effect on control of HIV infection, support the scientific validity of Remune or are consistent with the clinical development pathway for Remune, whether any 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 that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Remune(TM) is a registered 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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Always watch for outdated information. This article first appeared in 1999. This material is designed to support, not replace, the relationship that exists between you and your doctor.
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