Principal Investigator Reports 'Study Links Strong HIV-Specific
Immune Responses With Control of Virus'
BARCELONA, Spain, July 11 /PRNewswire-FirstCall/ --
Before a global audience at the XIV International AIDS Conference,
The Immune Response Corporation (Nasdaq: IMNR) announced today that data from
a Phase II clinical trial (STIR - 2102) of REMUNE(R) was presented by
Dr. Eduardo Fernandez-Cruz, head of Department of Clinical Immunology at the
University General Hospital "Gregorio Maranon" in Madrid, Spain, and lead
researcher on the study, which shows that treatment with the therapeutic
vaccine stimulated HIV-specific immune responses correlated with control of
virus in a three-year, 243-subject, double-blind, adjuvant-controlled trial.
The independent research team, led by Dr. Fernandez-Cruz, stated in the
study's released abstract, that "therapeutic vaccination induces a decrease of
immune system activation, an increase of HIV-specific helper T-cell activity,
an increase in killer cells and induces a positive impact on the control of
virus."
"This is the first opportunity this data set has been presented to the
global AIDS community and we believe the findings are promising," said
Dr. Dennis Carlo, president and chief executive officer of The Immune Response
Corporation.
In the overall study -- which was conducted from 1997-2001 -- patients
receiving a combination of REMUNE(R) and antiviral medication demonstrated a
delay in the time to reach virologic failure compared to the control group
(Cox stratification model, p<0.05) as previously reported (see company press
release dated February 28, 2002). The potential efficacy of REMUNE(R),
administered in combination with ART or HAART, was assessed by comparing the
time to increases in viral load and decreases in CD4+ T cell counts between
patient groups that received antiretroviral therapy plus REMUNE(R) or either
therapy plus placebo. Study results indicated that REMUNE(R) was shown to be
safe and well tolerated.
"In a pre-specified group of 54 subjects, a significant lymphocyte
proliferative helper T-cell immune response was observed in the REMUNE(R)
treated group compared to controls (P<0.05). Lymphocyte Proliferation Assays
(LPAs) were performed to determine the immune system's ability to recognize
and respond to HIV," said Dr. Fernandez-Cruz. "LPAs involve testing the
efficiency of the immune system by exposing a blood sample to HIV proteins and
monitoring the intensity of the helper T-cell response."
Furthermore, higher levels of cytotoxic T cells (killer cells) were
observed in the REMUNE(R) group compared to the control group (P<0.05).
Cytotoxic T cells recognize and kill virus-infected cells. Helper T-cells and
cytotoxic T cell activity correlated (r=0.44, P<0.05). Additionally, killer
cell activity correlated with control of virus in the REMUNE(R) treated group
(r=-0.58, P<0.05).
"We were pleased to confirm the hypothesis that immunity can be boosted in
chronic HIV infection," said Dr. Fernandez-Cruz. "Furthermore, the inducement
of cytotoxic T cells that correlate with the control of virus is extremely
important."
"We believe this is the most comprehensive study to date on REMUNE(R)'s
ability to impact on immunological and virological markers," said Dr. Ronald
Moss, vice president of medical and scientific affairs of The Immune Response
Corporation.
As previously reported, the primary endpoint was met for this
double-blind, placebo-controlled, three-year study to determine the effect of
REMUNE(R) on the maintenance of virologic suppression in 243 HIV infected
subjects on antiviral therapy (see also the company's press release dated
August 30, 2001).
Co-founded by medical pioneer Dr. Jonas Salk and based in Carlsbad,
Calif., The Immune Response Corporation is a biopharmaceutical company
developing immune-based therapies designed to treat HIV, autoimmune diseases
and cancer. The Company also develops and holds patents on several
technologies that can be applied to genes in order to increase gene expression
or effectiveness, making it useful in a wide range of therapeutic applications
for a variety of disorders. Company information is available at
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 Company will successfully raise
proceeds from financing activities sufficient to fund additional trials and
development of REMUNE(R), whether clinical trials of REMUNE(R) will be
successfully completed, and whether REMUNE(R) will be approved for marketing
or be successfully commercialized. These and other 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, 2001 and
report on Form 10-Q for the quarter ended March 31, 2002. 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(R) is a registered trademark of The Immune Response Corporation.
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
CONTACT:
media, James Lee of The Lee Strategy Group,
+1-310-229-5771, fax +1-310-229-5772, jlee@leestrategy.com, for
The Immune Response Corporation; or investors, Kathy Lane of The
Immune Response Corporation, +1-760-771-2236, fax
+1-760-771-2140, info@imnr.com
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