- Results Presented at the Keystone Symposium on HIV Vaccine Development -
CARLSBAD, Calif., April 14 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (Nasdaq: IMNR), a biopharmaceutical company developing immune-
based therapies for HIV and select other diseases, announced today that
preclinical data for its newest product candidate, IR103, were presented at
the Keystone Symposium on HIV Vaccine Development held this week in Whistler,
British Columbia. The data presented showed that IR103, an immune-based
therapy comprised of a gp120-depleted HIV-1 immunogen (REMUNE(R)) and a
second-generation immunostimulatory oligonucleotide adjuvant (Amplivax(TM)
developed by Hybridon, Inc. (Amex: HBY)), demonstrated potent HIV-1 specific
immunogenicity. These data warrant continued development of IR103 as a
potential therapy for individuals living with HIV.
"These experimental data on IR103 support our belief in the product
candidate and its continued development," said John N. Bonfiglio, Ph.D., Chief
Executive Officer of The Immune Response Corporation. "We believe that there
is a significant role for both REMUNE(R) and IR103 in the future of HIV
treatment and we are working hard to develop a focused clinical program that
will demonstrate their utility, while progressing towards commercial
availability. We plan to start human clinical safety trials with IR103 later
this year."
"We are excited that these data show the enhanced activity of IR103 and
are hopeful that our continued research will demonstrate a clear therapeutic
benefit to the millions of people living with HIV who need new options," said
Georgia Theofan, Ph.D., Vice President of Clinical Development at The Immune
Response Corporation. "We believe that the activities of REMUNE(R) and IR103
make them both viable candidates that will find roles in the treatment of this
devastating disease."
The data presented at this meeting were generated in a mouse model to
study the potential of inducing enhanced HIV-specific immune responses with
the combination of the REMUNE(R) immunogen and Amplivax(TM), a second-
generation immunostimulatory oligonucleotide adjuvant. The study demonstrated
that the combination, IR103, showed significant enhancement of several key
immune markers. Induction of both humoral (antibody) and cell mediated
immunity (CMI) were observed. The addition of Amplivax(TM) to REMUNE(R)
resulted in a dose-dependent enhancement of HIV-specific interferon-gamma,
IL-10, and chemokine production (RANTES, MIP-1 alpha, and MIP-1 beta), and a
decrease in IL-5 production, as well as increased production of p24
antibodies. This pattern is characteristic of the type of immune response
thought to be necessary for a therapeutic effect against HIV.
"We believe these data demonstrate the validity of our approach to the
treatment of HIV and give us a clear signal to continue the development of
REMUNE(R) and IR103 for treatment of HIV-1 infection. We are currently
generating additional data on these vaccines which will be presented at
scientific meetings later this year," continued Dr. Bonfiglio. "Additionally,
the clinical data being generated from our NeuroVax(TM) multiple sclerosis
program adds both depth and diversity to our pipeline."
The Keystone Symposia, an independent nonprofit organization based in
Colorado, was originally established in 1972 as the UCLA Symposia on Molecular
and Cellular Biology and was renamed in 1997. With approximately
45 conferences held per year; each range in length from 3 to 5 days attracting
an average of 250 participants per meeting, the Keystone Symposia are designed
to serve as a catalyst for the advancement of biomedical and life sciences by
connecting scientists within and across disciplines. Each meeting consists of
invited speakers presenting data on the most recent scientific achievements in
a variety of fields.
About The Immune Response Corporation
The Immune Response Corporation (Nasdaq: IMNR) is developing immune-based
therapies (IBT) for HIV and select other diseases. The Company's HIV products
are based on its patented whole-killed virus technology, co-invented by
Company founder, Dr. Jonas Salk, to stimulate HIV immune responses.
REMUNE(R), currently in Phase II, is being developed as a first-line treatment
for people with early-stage HIV. The Company has initiated development of a
new IBT, IR103, which incorporates a second-generation immunostimulatory
oligonucleotide adjuvant.
The Immune Response Corporation is also developing an IBT for multiple
sclerosis (MS), NeuroVax(TM), which is currently in Phase II and has shown
potential therapeutic value for this difficult-to-treat disease.
Please visit The Immune Response Corporation on the World Wide Web at
http://www.imnr.com
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 REMUNE(R), NeuroVax(TM) 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
REMUNE(R), NeuroVax(TM) 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
REMUNE(R), NeuroVax(TM) or IR103 in preclinical trials and/or earlier clinical
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, 2003, and any subsequent Quarterly
Reports 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. Amplivax(TM)
is a trademark of Hybridon, Inc. (Amex: HBY)
MEDIA CONTACT:
Laura Silver, Sam Brown Inc. Corporate Communications
310-551-9940
silver@sambrown.com
INVESTOR RELATIONS CONTACT:
Kathy Waller, Financial Relations Board
312-266-7800
kwaller@financialrelationsboard.com
AT THE COMPANY:
Michael K. Green, Chief Financial Officer
760-431-7080
info@imnr.com
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
CONTACT:
Media, Laura Silver of Sam Brown Inc.
Corporate Communications, +1-310-551-9940, silver@sambrown.com,
or Investor Relations, Kathy Waller of Financial Relations Board,
+1-312-266-7800, kwaller@financialrelationsboard.com, both for
The Immune Response Corporation; or Michael K. Green, Chief
Financial Officer of The Immune Response Corporation,
+1-760-431-7080, info@imnr.com
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