Data Presented at the Federation of Clinical Immunology Societies (FOCIS)
1st Annual Meeting in Boston, Massachusetts May 4-7, 2001
CARLSBAD, Calif., May 21 /PRNewswire/ -- The Immune Response Corporation
(Nasdaq: IMNR) announced today data from preliminary interim clinical results
from an ongoing Phase II trial indicating that treatment with REMUNE(TM)
(HIV-1 Immunogen), an investigational product, appears to induce both allo and
HIV specific cell mediated immune responses. Allo (allo-geneic) immune
responses are directed to Human Leukocyte Antigens (HLA) and are associated
with development of both CD4+ T helper and CD8+ Cytotoxic T cell (CTL) immune
responses. Recently other researchers have proposed allo-antigen immunization
as an additional strategy for HIV-1 vaccination. Professor Eduardo Fernandez-
Cruz, M.D., Ph.D., Head of the Department of Clinical Immunology at the
University General Hospital "Gregorio Maranon" in Madrid, Spain and Principal
Investigator in the study STIR 2102 trial of REMUNE in Spain, presented data
at the Federation of Clinical Immunology Societies (FOCIS) 1st Annual Meeting
in Boston, Massachusetts (published in Clinical Immunology, Volume 99, April
2001).
The data analyzed a subset of 66 HIV-infected patients from a double
blind, adjuvant controlled, randomized Phase II trial of REMUNE (STIR 2102)
conducted in Spain. The 243 patient trial is designed to evaluate the
effectiveness of REMUNE in conjunction with antiretroviral drugs on viral load
and CD4 cells, which are the primary endpoints. The trial is being conducted
at 13 clinical centers throughout Spain and is scheduled to end in the second
quarter of 2001.
Patients treated with REMUNE plus antiretrovirals appeared to exhibit both
humoral (allo-antibodies) and cell mediated (CD4+ T helper and CD8+ Cytotoxic
T cell) allo-immune responses. In the REMUNE treated group, 74% (25/34) of
the patients exhibited anti-HLA antibodies (an allo-immune response), compared
to only 25% (8/32) of the patients who received placebo (p<0.0001).
Additionally, the REMUNE treated group demonstrated significantly higher
T helper and Cytotoxic CD8+ T cell responses to allo-antigens compared to the
placebo group (p<0.05). "Allo-antigens presented together with HIV-1 antigens
in a single vaccine may potentially further stimulate the generation of HIV
specific immune responses," said Professor Fernandez-Cruz. "REMUNE treated
patients who elicited allo-antibodies demonstrated higher HIV-1 specific
immune responses than patients without allo-antibodies."
"These data are the first to indicate that treatment with a therapeutic
vaccine, REMUNE, can enhance allo-immune responses along with HIV specific
immune responses," said Professor Fernandez-Cruz. "Allo and HIV specific
immune responses are lost early in HIV-1 disease and the ability to restore
them may be important for control of HIV-1."
Previously (13th International AIDS Conference in Durban, South Africa,
See Press Release, July 13, 2000), Professor Cruz had presented data from the
same study that REMUNE treated subjects appeared to have enhanced HIV specific
T helper and functionally active CD8+ T cells also known as "killer cells"
which are capable of killing cells infected with HIV.
"Although several previous trials have indicated that REMUNE induces HIV-
specific immune responses, this is the first time that we have seen
stimulation of allo-responses as well," Professor Fernandez-Cruz noted. "If
the ability to restore allo-responses does in fact relate to the ability to
generate and potentiate anti-HIV immune responses, then treatment with REMUNE
may offer a 'two-mechanism attack' against the virus by stimulating both HIV-
specific and allo-immune responses."
REMUNE is currently the subject of several clinical trials, including a
Phase II trial being conducted in Spain and a Phase III trial sponsored by the
Company's partner Agouron Pharmaceuticals, Inc. (a Pfizer company) to evaluate
REMUNE's effect on viral load when administered in combination with potent
antiviral drug therapy. Impact on viral load is now a measure of efficacy
that is accepted by the Food and Drug Administration.
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. 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 preclinical data can be replicated in
clinical trials, whether if initiated clinical trials will be successfully
concluded and whether a preventative vaccine 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, 2000 and subsequent
Form 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
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CONTACT:
Investors, Kathy Lane, 760-771-2236, or
Media, Laura Hansen, Ph.D., 858-860-0266, both of The Immune
Response Corporation
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