- Preliminary Results From Ongoing Clinical Trial in Italy Suggest REMUNE(R)
Has Activity in Drug-Naive Patients -
- Pre-Clinical Data Point to Potential of IR103 Combination to Boost
This Effect -
CARLSBAD, Calif., June 7 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (Nasdaq: IMNR), a biopharmaceutical company dedicated to becoming
a leading immune-based therapy company in HIV and multiple sclerosis (MS),
announced that research results, presented Saturday at the International
Symposium on HIV & Emerging Infectious Diseases in Toulon, France, suggest its
lead product candidate, REMUNE(R) (HIV-1 immunogen), may produce an HIV-1
specific immune response in drug-naive HIV-1 infected patients. The Company
has also produced laboratory evidence that its second product candidate,
IR103, which combines REMUNE(R) with an immunostimulatory oligonucleotide
adjuvant Amplivax(TM), generated robust HIV-1 specific immune responses in a
number of assays. Ability to generate HIV-1 specific immune responses is
thought to be an important indicator of clinical utility. Additional studies
are planned to investigate the clinical benefit of both products.
"These early clinical data from the Phase II trial in Italy represent
further evidence that REMUNE(R) can generate the HIV-specific responses many
investigators believe is necessary to be a useful therapeutic tool," said John
N. Bonfiglio, Ph.D., Chief Executive Officer of The Immune Response
Corporation. "The research models with Amplivax(TM) will help us plan our
next stage of studies for IR103 which we hope to begin shortly. Moreover,
this data demonstrates our continued progress toward our goal of achieving all
of our published milestones."
In addition to preliminary results from an ongoing Phase II clinical
trial, being conducted in Italy, in drug-naive HIV-1 infected patients, the
investigators presented findings from two research models that IR103, the
combination of REMUNE(R) with Amplivax(TM), amplified HIV-1 specific immune
activity over REMUNE(R) alone. On the basis of these encouraging laboratory
results, the Company plans to evaluate the clinical potential of IR103 to
enhance immune response by adding Amplivax(TM) to the REMUNE(R) vaccine
patients in the ongoing study are currently receiving.
"It is encouraging to have evidence from two different models that the
HIV-1 specific immune response can be enhanced with our IR103 product. Our
clinical development plans for this year will generate more data in humans
with IR103 in both drug-naive patients and patients currently on
antiretroviral therapy. These data will allow us to evaluate the clinical
opportunities for both IR103 and REMUNE(R)," said Georgia Theofan, Ph.D., Vice
President of Clinical Development at The Immune Response Corporation.
In the preclinical model, mice immunized subcutaneously with IR103 showed
significantly enhanced production of a number of key markers of HIV-specific
immune responses, including gamma interferon (IFN-g) and important chemokines
such as RANTES, MIP-1alpha, MIP-1beta and p24 antibody, when compared to those
immunized with REMUNE(R) alone. These data demonstrate the potential to
enhance both cell-mediated and humoral immunity, both of which are considered
important in mounting an effective immune response against HIV.
In the ex-vivo study, Amplivax(TM) was investigated for its ability to
enhance HIV antigen stimulation from HIV+ patients treated with antiretroviral
therapy (ART). Results showed that Amplivax(TM) increased HIV-specific cell-
mediated immune responses from patients vaccinated with REMUNE(R), as measured
primarily by IFN-g production.
Amplivax(TM) was developed by Hybridon, Inc. and has been licensed to The
Immune Response Corporation.
About The Immune Response Corporation
The Immune Response Corporation (Nasdaq: IMNR) is a biopharmaceutical
company dedicated to becoming a leading immune-based therapy company in HIV
and multiple sclerosis (MS). 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 clinical trials, 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 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.
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,
for The Immune Response Corporation; or investor relations, Kathy
Waller of Financial Relations Board, +1-312-266-7800,
kwaller@financialrelationsboard.com, 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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