CARLSBAD, Calif., Sept. 29 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (Nasdaq: IMNR) today announced the initiation of a Phase II
clinical study designed to evaluate the use of REMUNE(R), an immune-based
therapeutic vaccine, for treatment of HIV-infected patients who have not been
treated previously with antiretroviral drugs. The study, which will enroll
patients at several medical centers in Italy, is designed to utilize
state-of-the-art immunology methods to assess the magnitude of HIV-specific
immune responses to REMUNE in drug-naive patients. The goal of the study is
to generate data to aid in the design of future registration trials that would
determine the ability of REMUNE to slow HIV disease progression and delay the
need for antiretroviral agents.
"Long-term antiretroviral therapy, while effective, is associated with the
development of drug resistance and drug-related toxicity that has negative
effects on the quality of life," explained Andrea Gori, M.D., of the
University of Milan's Luigi Sacco Hospital, who is the study's principal
investigator. "Using immune-based therapeutics such as REMUNE to delay
antiretroviral therapy could be an important step in improving patient care."
This study is another milestone for The Immune Response Corporation, which
has recently improved its financial position and revised its clinical
development strategy under the leadership of a new management team. The new
Italian study is a randomized, controlled trial that will enroll 50 male and
female HIV-infected patients who have never received antiretroviral therapy.
As announced in June, the Company has also commenced a Phase II study in Spain
designed to explore the potential for REMUNE to help HIV-infected patients
maintain control of the virus following interruption of antiretroviral
therapy.
"The launch of this new study is an important step in the execution of our
clinical development strategy," noted Georgia Theofan, Ph.D., Vice President
of Clinical Development. "We intend to explore the utilization of REMUNE in
distinct patient populations where we believe it has the potential to offer
clinical advantages in the context of current treatment strategies. We expect
this study to generate data that we can use in discussions with the regulatory
authorities and advisors to plan future registration trials."
About The Immune Response Corporation and REMUNE(R)
The Immune Response Corporation is a biopharmaceutical company dedicated
to treating and preventing HIV and AIDS through the development of
immune-based therapeutic vaccines such as REMUNE, its lead product candidate.
The Company was co-founded by medical pioneer Dr. Jonas Salk, who was
instrumental in the formulation of REMUNE, which is currently in Phase II
clinical development.
HIV, the human immunodeficiency virus, is the virus that causes AIDS, a
condition that slowly destroys the body's immune system, making it vulnerable
to infections. REMUNE is designed to induce a specific immune response to the
HIV virus. It is comprised of HIV-1 virus that has been chemically killed and
inactivated so that it is non-infectious, plus an adjuvant that helps enhance
the body's immune response to the virus. More than 60 million people have
been infected with HIV since it was first recognized in 1981, and
approximately 40 million people around the world are living with HIV today.
This news release contains forward-looking statements. 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 REMUNE, the uncertainty of
successful completion of any such clinical trials, whether REMUNE will be
effective as either a preventive or therapeutic vaccine, whether future trials
will be conducted and whether the results of such trials will coincide with
the results of REMUNE in preclinical trials. These risks, among others, are
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,
2002, and subsequent Quarterly Reports on Form 10-Q. The Company undertakes
no obligation to publicly release the results 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:
The Immune Response Corporation
(Investors) - Kathy Lane, (760) 771-2236 or info@imnr.com
(Media) - Gwen Rosenberg, (858) 759-0759
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
CONTACT:
Investors, Kathy Lane, +1-760-771-2236,
info@imnr.com, or Media, Gwen Rosenberg, +1-858-759-0759, both of
The Immune Response Corporation
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