CARLSBAD, Calif., July 11 /PRNewswire/ -- The Immune Response Corporation
(Nasdaq: IMNR) announced today that the principal investigator Professor
Eduardo Fernandez-Cruz, M.D., Ph.D., presented new virological findings from
the Phase II clinical trial (STIR 2102) completed in Spain with REMUNE(TM)
(HIV-1 Immunogen), an investigational immune-based therapy. Professor
Fernandez-Cruz is Head of the Department of Clinical Immunology at the
University General Hospital "Gregorio Maranon" in Madrid, Spain.
The study results, presented at the 1st International AIDS Society
Conference on HIV Pathogenesis and Treatment in Buenos Aires, Argentina, were
analyzed by Dr. Fernandez-Cruz and his colleagues, the Company and three
outside consultants engaged by the Company to independently review the data
using the intent-to-treat principle. Statistical analyses included the
information from patients in both the treatment phase (patients who remained
on stable ART [AZT plus ddI] treatment) and the follow-up phase (patients who
switched from ART treatment to a three drug HAART regimen [3TC, D4T, and
Indinavir]). Treatment plus follow-up observation times showed a protective
effect of REMUNE on time to virological failure when compared to placebo
(Hazard Ratio = 0.66, p= 0.054). Regression analysis (Cox Proportional
Hazards Model) which stratified the primary endpoint on baseline viral load
(above and below 10,000 copies/ml) and CD4 (above and below 400 cells per
cubic mm) increased the differences showing a significant effect of REMUNE
(Hazard Ratio = 0.63, p= 0.036) on time to virologic failure. Patients who
remained on stable ART (AZT plus ddl) treatment, showed no difference in time
to virologic failure between treatment and placebo groups.
The intent-to-treat principle dictates that data from every patient
enrolled in the study, at all timepoints, be included in the analysis. Viral
load is the amount of HIV detected in the blood. The hazard ratio is a ratio
of the probability of developing an endpoint in the treatment group, compared
to the probability of developing an endpoint in the placebo group. Therefore,
a hazard ratio that lies between 1 and 0 demonstrates a protective effect of
treatment. For example, a hazard ratio of 0.5 denotes the probability of
developing an endpoint in the treatment group is one-half of the probability
of developing an endpoint in the placebo group.
As reported by the Company on June 1, 2001, the independent Data and
Safety Monitoring Board (DSMB) met earlier to review the results of this
study. At the time, however, the DSMB did not have available to it the
intent-to-treat analysis. The Company now anticipates that the DSMB will
evaluate these data presented by Dr. Fernandez-Cruz.
"The results from this trial have identified for the first time that
REMUNE can exert a significant effect on viral load in immunocompetent chronic
HIV-1 infected patients," said Dr. Fernandez-Cruz. "We are encouraged by
these findings and believe that this study has yielded important information
for the future development and application of therapeutic vaccination in HIV-1
infection."
The study, conducted at 13 major clinical centers throughout Spain, was a
multicenter, double-blind, placebo-controlled, randomized trial of 243
antiviral naive patients with chronic HIV infection with CD4+ T cells between
300-700 cells/mL. Viral load measured at study entry ranged in this
population from less than 10,000 copies/mL to greater than 100,000 copies/mL.
The efficacy of REMUNE, 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 ART or HAART plus
REMUNE or either therapy plus placebo. The maximum time each patient received
ART was 36 months and HAART was 24 months. Patients were allowed to switch to
HAART for virologic failures or medical reasons (toxicity) associated with
previous ART therapy. Study results indicated that REMUNE was shown to be
safe and well tolerated.
REMUNE, an HIV-specific immune-based therapy under development, is a
proprietary formulation of modified, killed HIV that is designed to stimulate
T cells to produce an immune response to HIV-specific antigen. It is hoped
that this enhanced immune response will help to control infection and
consequently slow the progression to AIDS.
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: 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 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, 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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Related links:
http://www.imnr.com
CONTACT:
Media, Jakob Jakobsen of Ogilvy Public
Relations Worldwide, 310-407-7910, for Immune Response
Corporation; or Investors, Kathy Lane, 760-771-2236, for Immune
Response Corporation
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