CARLSBAD, Calif., June 1 /PRNewswire/ -- The Immune Response Corporation
(Nasdaq: IMNR) announced today that an independent Data Safety Monitoring
Board (DSMB) has evaluated the results from a phase II clinical trial
(STIR 2102) completed in Spain with REMUNE(TM) (HIV-1 Immunogen), an
investigational immune-based therapy. The results indicated that the study
did not meet the primary endpoint (i.e. time to increase to 5,000 copies/ml
of viral load [the amount of HIV detected in the blood] or a 50% decrease in
CD4+ T cells/ml or a decrease to less than 250 CD4+ T cells/ml while on
antiretroviral therapy [ART]). The primary endpoint analysis revealed no
significant difference between the control group 41% (50/121) and the REMUNE
group 30% (35/118) p=0.20.
The DSMB also noted however, that their study included a subgroup analysis
that seemed to indicate that REMUNE may have had a positive effect on viral
load in patients that are more immunocompetent. The DSMB recommended further
studies with REMUNE in such patients.
Results from this trial will be presented by the principal investigator
Professor Eduardo Fernandez-Cruz, M.D., Ph.D., on June 25, 2001, at the Sixth
European Conference on Experimental AIDS Research in Edinburgh, Scotland.
Professor Fernandez-Cruz is Head of the Department of Clinical Immunology at
the University General Hospital "Gregorio Maranon" in Madrid, Spain.
"The treatment of HIV infection is remarkably complex and there is an
increasing need for new immune based therapies. The results of this trial may
have identified the patient population that is potentially immunologically
capable of responding to an immune based therapy in which therapeutic
vaccination with REMUNE may exert a positive impact on viral load," said Dr.
Fernandez-Cruz.
The study conducted in 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 antiretroviral therapy (ART), was assessed by
comparing the time to increases in viral load and decreases in CD4 T cell
counts between patient groups that received ART plus REMUNE or ART plus
placebo. The trial was conducted at 13 major clinical centers throughout
Spain.
REMUNE, an HIV-specific immune-based therapy under development, is a
special preparation 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. REMUNE is the subject of
investigation in several clinical trials including a trial sponsored by
Agouron Pharmaceuticals, Inc. and The Immune Response Corporation.
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: 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 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 The Immune Response Corporation
 back to top
Related links:
http://www.imnr.com
Company News On-Call:
http://www.prnewswire.com/comp/434675.html or fax,
800-758-5804, ext. 434675
CONTACT:
Media, Jakob Jakobsen, Ogilvy Public
Relations Worldwide, 310-407-7910; Investors, Kathy Lane,
760-771-2236; or Laura Hansen, Ph.D., Susan E. Atkins &
Associates, 858-860-0266
|
