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The Immune Response Corporation Announces Publication of Study Suggesting That REMUNE(TM) Induces HIV-1 Specific T Helper Immune Responses That Correlate With Control of Virus

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Hallo an Alle

Hier ist die Antwort:The Immune Response Corporation Announces Publication of Study Suggesting That REMUNE(TM) Induces HIV-1 Specific T Helper Immune Responses That Correlate With Control of Virus

CARLSBAD, Calif., April 23 /PRNewswire Interactive News Release/ -- The
Immune Response Corporation (Nasdaq: IMNR) announced the publication of data
today that suggest REMUNE(TM) (HIV-1 Immunogen), an investigational
immune-based therapy, induces HIV specific (T helper cells) immune responses
that correlate with control of virus (viral load, the amount of HIV in the
bloodstream) in HIV-positive individuals. An analysis of a protocol defined
random cohort from a Phase 3 study showed that patients treated with REMUNE
demonstrated a statistically significant reduction in viral load at multiple
time points throughout the trial, regardless of concomitant antiretroviral
drug therapy. The results of the study appear in the April edition of HIV
Medicine (http://www.BlackwellScientific.com), the official Journal of the European
AIDS Clinical Society and the British HIV Association.
The protocol defined random cohort involved 252 HIV-positive individuals
who received injections of either REMUNE or a placebo (Incomplete Freund`s
Adjuvant) in addition to un-restricted anti-retroviral drug use. A
2500-patient, multi-center, double-blind, adjuvant-controlled, clinical
endpoint Phase 3 study begun in 1996 included this cohort study that was
designed to determine the relationship between viral load (amount of virus in
the blood) and HIV-specific immunity.
Viral load was measured as HIV-1 plasma RNA levels every 12 weeks, more
frequently than in other patients in the larger study (whose viral load was
measured every 24 weeks). In the REMUNE treated group, a significantly
greater decline in viral load (p<0.05) at multiple time points was observed.
These differences in viral load were not significant for the first two
time-points but were observed at week 36 (p=0.01), and were maintained at
weeks 48 (p=0.02), 60 (p=0.02), 84 (p=0.001), 96 (p=0.004), and 120 (p=0.03).
The authors believe that the apparent 36-week "lag time" between the initial
treatment with REMUNE and a significant reduction in viral load may suggest
that the immune system requires a period of time after immunization to
organize specific immune forces against the virus. Lymphocyte Proliferation
Assays (LPAs) were also performed on blood samples taken every 24 weeks. LPAs
are a common measure of the ability of the immune system to respond to HIV via
T helper cells. LPA test results indicated that HIV-specific T helper cell
immune responses were generated only in the REMUNE treated group (p<0.0001).
In the REMUNE treated group, LPA to HIV antigens after immunization (24 weeks)
correlated with the amount of virus in the blood (week 24, r=-0.32, p=0.002;
week 48, r=-0.42, p=0.001; week 72, r=-0.29, p=0.05; week 96, r=-0.35,
p=0.003; week 120, r=-0.53, p=0.001).
"Since many of these patients were taking potent antiretroviral drugs and
were permitted to switch drugs ad lib, we expected to see a decrease in viral
load in both the placebo group and the REMUNE group," said John Turner, M.D.,
of the Graduate Hospital (Philadelphia, PA) and principal author of the study.
"The data indicate, however, that patients treated with REMUNE tended to
exhibit an even greater decrease in viral load when compared to the placebo
group. The random cohort was sampled every three months for viral load. I
believe that it is possible that the less frequent viral load sampling on the
larger cohort which was obtained every six months (including a majority of the
435 patients on potent antiretroviral therapies at the beginning of the
study), where little difference between the treatment groups was observed,
impacted on the ability to detect effects of immunization on viral load. This
is most likely due to the multiple antiviral drug switching which occurred
during this trial. Most importantly, there was a correlation between the
induced HIV specific T helper immune responses and control of the amount of
virus in the blood. These findings further support the plausibility of the
results in the random cohort. As the leading enrolling investigator in study
806, I am pleased that the details of this important information have been
peer reviewed by HIV clinical experts and are now available to the HIV and
scientific communities."
"Most HIV-positive individuals lose the ability to recognize and respond
to HIV soon after becoming infected despite treatment with antiretroviral
drugs. The LPA results indicate that REMUNE may restore HIV specific T helper
immune responses," said Dr. Turner. "This is significant because HIV-1
specific immune responses, as shown by other investigators, are associated
with the ability to control the level of virus in the blood in HIV-positive
individuals who do not progress to AIDS. We observed for the first time a
correlation between vaccine-induced HIV specific T helper responses in chronic
HIV infection and control of virus."
The 252 HIV-positive individuals involved in the published study were a
randomly selected subset from a larger 2500-patient, multi-center,
double-blind, adjuvant-controlled Phase 3 clinical study begun in 1996. All
participants in the study were asymptomatic and had CD4 cell counts of
300-549cc/mm(3). There were no prerequisites as to the use of antiretroviral
drug therapy; patients were allowed to take any combination of drugs and to
switch combinations throughout the duration of the trial. Patients were
randomized to receive intramuscular injections of either REMUNE or a placebo
(Incomplete Freund`s Adjuvant) once every 12 weeks for 120 weeks. The trial
was discontinued in May of 1999 when an independent data safety monitoring
board determined that the trial would not reach statistical significance on
the primary endpoints of progression to AIDS related illnesses or death (see
Company Form 8-K dated May 14, 1999 and filed with the SEC on July 6, 1999).
The trial was designed for a 6% per year rate of progression to AIDS or death
as endpoints. During the trial, because of the fewer than expected clinical
events, the endpoint definition was modified to include non-AIDS defining
events. When the trial was stopped it was determined that the actual rate of
progression to AIDS or deaths was <1% per year.
REMUNE is currently the subject of several clinical trials, including a
Phase 2 trial being conducted in Spain and a Phase 3 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 for approval of REMUNE.

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. 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.


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