- Vaccines' Ability to Strengthen Key Elements of the Immune System Holds
Promise for New Approach to HIV Treatment -
CARLSBAD, Calif., Feb. 15 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (OTC Bulletin Board: IMRP) today announced preliminary Phase II
study results suggesting that both REMUNE(R) and IR103, its first and
second generation HIV vaccine candidates, stabilize CD4+ T-cell counts
compared with placebo in HIV patients who have not started antiretroviral
(ARV) therapy. The 36-week data are from a year-long multi-center safety
and immunogenicity study expected to conclude in 2008.
CD4+ T-cells, also known as helper T-cells, are key elements of the
immune system and are specifically attacked and killed by the HIV virus.
CD4+ count is a critical marker of HIV disease progression that is used in
clinical decision-making. Unlike currently available drugs that attack the
virus, REMUNE(R) and IR103 are designed to stimulate the body's own immune
system to better fight the virus by boosting T-cell activity.
"What is important and encouraging here is that the stabilization of
CD4+ counts mirrors what we observed in an earlier 28-week study, presented
last year at the Conference on Retroviruses and Opportunistic Infections,
and suggests that this effect is reproducible and can be sustained for at
least 36 weeks," said Dr. Joseph O'Neill, President and CEO of The Immune
Response Corporation. "IRC is committed to rigorous science and we look
forward to the full 52-week trial results to help inform our future
planning."
The goal of The Immune Response Corporation's research program is to
deliver important clinical advances for patients suffering from devastating
diseases. The Company's investigational vaccines for HIV and multiple
sclerosis are highly targeted, potentially less toxic medicines that seek
to harness the body's own defenses to control and prevent disease. This
approach may prove valuable in the discovery of novel immune-based
therapies for a host of autoimmune and infectious diseases.
The concept of an immune based treatment for HIV, pioneered by
REMUNE(R), has attracted the interest of researchers, physicians, and
patients around the world. Immune Responses' approach, which uses a
whole-inactivated virus, may offer particular advantages in that it exposes
the immune system to all of the core HIV proteins. "These data lend
credence to the hypothesis that exposing HIV infected patients to an
inactivated form of HIV, together with an appropriate adjuvant, could
stimulate HIV specific immune responses and thereby prevent or retard
further decline in immune function," said Dr. Peter Salk, a member of the
Company's Scientific Advisory Board. "Should this approach to HIV treatment
ultimately demonstrate clinical benefit it would be of great importance in
the global fight against the HIV/AIDS pandemic."
About the Study
The trial (IR103-112) is a randomized, double-blind, multi-center
safety study being conducted in Italy. The objective of the study is to
examine the safety and the ability of REMUNE(R) and various doses of IR103
to generate HIV-specific immune responses in antiretroviral-naïve HIV
infected subjects compared to placebo.
Patients in this interim analysis received either REMUNE(R) (n=10),
IR103 0.1 mg (n=11), IR103 0.5 mg (n=11), IR1031.0 mg (n=11), or saline
(n=12) every 12 weeks via intramuscular injection. CD4+ cell counts were
measured at baseline and at weeks 4, 12, 24 and 36. While the data will not
be statistically analyzed until completion of the trial, the data show a
trend toward stabilization of CD4+ count in the immunized patients as
compared to placebo at weeks 24 and 36.
No substantive difference in effect on CD4+ count was seen between
REMUNE(R) and IR103 and no impact on viral load was detected at this point
in the trial as compared to placebo.
Immunologic results from this initial cohort of 55 patients will be
analyzed when they complete 52 weeks in the study. These data are expected
to be submitted for presentation at a medical congress in mid 2007.
About The Immune Response Corporation
The Immune Response Corporation (OTC Bulletin Board: IMRP, formerly
IMNR) is an immuno-pharmaceutical company focused on developing products to
treat autoimmune and infectious diseases. The Company's lead immune-based
therapeutic product candidates are NeuroVax(TM) for the treatment of
multiple sclerosis (MS) and REMUNE(R) and IR103 for the treatment of HIV
infection. These therapies are in Phase II clinical development and are
designed to stimulate disease pathogen-specific immune responses aimed at
slowing or halting the rate of disease progression.
NeuroVax(TM), which is based on the Company's patented T-cell receptor
(TCR) peptide vaccine technology, has shown potential clinical value in the
treatment of relapsing forms of MS. NeuroVax(TM) has been shown to
stimulate strong, disease-specific cell-mediated immunity in nearly all
patients treated and appears to work by enhancing levels of FOXP3+ Treg
cells that are able to down regulate the activity of pathogenic T-cells
that cause MS. Increasing scientific findings have associated diminished
levels of FOXP3+ Treg cell responses with the pathogenesis and progression
of MS and other autoimmune diseases such as rheumatoid arthritis (RA),
psoriasis and Crohn's disease. In addition to MS, the Company has open
Investigational New Drug Applications (IND) with the FDA for clinical
evaluation of TCR peptide-based immune-based therapies for RA and
psoriasis.
REMUNE(R) and IR103 are based on the Company's patented,
whole-inactivated virus technology, co-invented by Dr. Jonas Salk and
indicated to be safe and immunogenic in extensive clinical studies of
REMUNE(R), the Company's first generation HIV product candidate. IR103 is a
second-generation formulation that combines its whole-inactivated antigen
with a synthetic Toll-like receptor (TLR-9) agonist designed to create
enhanced HIV-specific immune responses. The Company is currently testing
REMUNE(R) and IR103 in two Phase II clinical studies as a first-line
treatment for drug-naive HIV-infected individuals not yet eligible for
antiretroviral therapy according to current medical guidelines.
NeuroVax(TM), REMUNE(R) and IR103 are in clinical development by The
Immune Response Corporation and are not approved by any regulatory agencies
in any country at this time. Please visit The Immune Response Corporation
at http://www.imnr.com for additional information.
This news release contains forward-looking statements. Forward-looking
statements are often signaled by forms of words such as should, could,
will, might, plan, projection, forecast, expect, guidance, potential and
developing. Actual results could vary materially from those expected due to
a variety of risk factors, including whether the Company will continue as a
going concern and successfully raise proceeds from financing activities
sufficient to fund operations and additional clinical trials of
NeuroVax(TM), REMUNE(R) or IR103, the uncertainty of successful completion
of any such clinical trials, the fact that the Company has not succeeded in
commercializing any drug, the risk that NeuroVax(TM), REMUNE(R) or IR103
might not prove to be effective as either a therapeutic or preventive
vaccine, whether future trials will be conducted and whether the results of
such trials will coincide with the results of NeuroVax(TM), REMUNE(R) or
IR103 in preclinical trials and/or earlier clinical trials. A more
extensive set of risks is set forth in The Immune Response Corporation's
SEC filings including, but not limited to, its Annual Report on Form 10-K
for the year ended December 31, 2005, and its subsequent Quarterly Reports
filed on Form 10-Q. The Company undertakes no obligation to update the
results of these forward-looking statements to reflect events or
circumstances after today or to reflect the occurrence of unanticipated
events.
REMUNE(R) is a registered trademark of The Immune Response Corporation.
NeuroVax(TM) is a trademark of The Immune Response Corporation.
MEDIA CONTACT: INVESTOR CONTACTS:
Rachel Kessler Robert Giordano
Chamberlain Communications Group Inc. ROI Associates
(212) 389-9155 (212) 495-0201
rkessler@chamberlainpr.com rgiordano@roiny.com
COMPANY CONTACT: INVESTOR CONTACTS:
Michael K. Green, COO Gene Marbach
The Immune Response Corporation Makovsky & Company
(760) 431-7080 (212) 508-9645
info@imnr.com gmarbach@makovsky.com
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
CONTACT:
Media, Rachel Kessler, Chamberlain
Communications Group Inc., +1-212-389-9155,
rkessler@chamberlainpr.com, for The Immune Response Corporation;
or Investors, Robert Giordano of ROI Associates, +1-212-495-0201,
rgiordano@roiny.com, for The Immune Response Corporation; or
Investors, Gene Marbach of Makovsky & Company, +1-212-508-9645,
gmarbach@makovsky.com, for The Immune Response Corporation; or
Michael K. Green, COO of The Immune Response Corporation,
+1-760-431-7080, info@imnr.com
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