CARLSBAD, Calif., Aug. 30 /PRNewswire/ -- As announced by The Immune
Response Corporation (Nasdaq: IMNR) on July 11, 2001, it was anticipated that
the independent Data Safety Monitoring Board (DSMB) would be meeting again to
evaluate the results of the Phase II clinical trial (STIR 2102) completed in
Spain with REMUNE(R) (HIV-1 Immunogen), an investigational immune-based
therapy to treat HIV infection, in light of data as reported by Dr. Eduardo
Fernandez-Cruz, the principal investigator of the trial.
The DSMB met recently to review the final analysis of the STIR 2102 trial
as defined by the statistical plan of the trial protocol. The DSMB has
advised that the analysis first reported by the DSMB and announced by the
Company on June 1, 2001, was insufficient, as it only included the treatment
time, but not the complete follow up time of all patients, and did not include
the intent-to-treat analysis. In addition, at its recent meeting, the DSMB,
among other things, reviewed the reports of the three outside statisticians
engaged by the Company, with the DSMB's concurrence, to independently review
the data and noted that these statisticians concurred that the most
appropriate primary analysis was the Cox regression model stratified by
baseline viral load in an intent-to-treat analysis.
After reviewing the data provided by the STIR 2102 protocol and the
reports and views of the protocol statistician and the three outside
statisticians, the DSMB expressed its view that REMUNE shows a positive impact
on controlling virus and the study had met its primary endpoint (p=0.034).
As previously announced on July 11, 2001, the results of the study were
presented at the 1st International AIDS Society Conference on HIV Pathogenesis
and Treatment in Buenos Aires, Argentina. The results were analyzed by Dr.
Fernandez-Cruz and the protocol statistician, the Company and the three
outside statisticians 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 virologic
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; the same analysis, stratified on baseline viral load
without CD4, also showed a significant effect of REMUNE on time to virologic
failure (Hazard Ratio = 0.63; p = 0.034). As previously reported, the
analysis of patients who remained on stable ART (AZT plus ddi) treatment
showed no difference in time to virologic failure between treatment and
placebo groups (Hazard Ratio = 0.80; p = 0.34); however, because this method
of analysis did not include follow-up time of patients who remained on the
study on stable HAART therapy, and in light of the aforementioned analyses,
the Company believes this analysis is no longer appropriate.
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.
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 Forms 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(R) is a registered trademark of The Immune Response Corporation.
For further information, please contact: media, Jakob Jakobsen of Ogilvy
Public Relations Worldwide, +1-310-407-7910; or Allison B. Small of Susan E.
Atkins & Associates, +1-858-860-0266, for The Immune Response Corporation.
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/434675.html
CONTACT:
media, Jakob Jakobsen of Ogilvy Public
Relations Worldwide, +1-310-407-7910; or Allison B. Small of
Susan E. Atkins & Associates, +1-858-860-0266, for The Immune
Response Corporation; or investors, Kathy Lane, +1-760-771-2236,
for The Immune Response Corporation
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