- Data Show Positive Trends in Key Immune Response Markers at 28 Weeks -
CARLSBAD, Calif., Nov. 17 /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,
presented preliminary data this week from an ongoing Italian Phase II study of
REMUNE(R) treatment in HIV positive, antiretroviral-naive patients at the
7th International Congress on Drug Therapy in HIV Infection meeting in
Glasgow, Scotland.
The analysis included data from 37 patients out of a total of 51 patients
enrolled in the study. In the group of patients who received three injections
of REMUNE(R) over the 28-week study period, several positive trends were
observed in key markers believed to indicate immune responses against HIV
disease, including trends toward stabilization of total CD4+ T-cell counts,
increased HIV-specific CD8+ memory T-cells, and decreased levels of activated
CD38+ T-cells, following REMUNE(R) treatment. The final analysis of this
study is expected by the end of the year.
"At first look, these data suggest that REMUNE(R) may be improving immune
response against HIV in these drug-naive patients. Further studies are
required to confirm if such responses can be sustained and result in clinical
benefit to patients who do not yet meet the criteria for initiation of
antiretroviral therapy," commented Mario Clerici, M.D., lead immunologist for
the study and Chair of Immunology at the University of Milan, Italy.
"We are encouraged by this data and, as a result, will expand our research
in HIV-naive patients," said Georgia Theofan, Ph.D., Vice President of
Clinical Development at The Immune Response Corporation. "We will begin a
rollover study to expand the data on REMUNE(R) and to test our newest HIV
product candidate, IR103 in this patient population."
The multi-center, single-blind, randomized study followed 51 patients over
28 weeks following treatment with REMUNE(R), Incomplete Freud's Adjuvant (IFA)
or saline. The study had two patient groups treated with either one or three
injections of REMUNE(R) and each of the other arms received three injections
of either IFA or saline. The four arms of the study each received injections
at weeks 0, 12 and 24. A rollover study to REMUNE(R) and IR103 is planned.
REMUNE(R) is in Phase II development by The Immune Response Corporation
and is not approved by any regulatory agencies in any country at this time.
Professor Clerici has served as a research investigator for The Immune
Response Corporation and has received research funding support from the
Company.
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. We have initiated development of a new
immune-based therapy, IR103, which incorporates a second-generation
immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II
clinical trials in Canada and the United Kingdom.
The Immune Response Corporation is also developing an immune-based therapy
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 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 its 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.
MEDIA CONTACT: INVESTOR CONTACT:
Laura Silver Michael K. Green
Sam Brown Inc. Corporate Communication Chief Financial Officer
310-551-9940 760-431-7080
silver@sambrown.com info@imnr.com
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
CONTACT:
Laura Silver of Sam Brown Inc. Corporate
Communication, +1-310-551-9940, silver@sambrown.com; or Michael
K. Green, Chief Financial Officer of The Immune Response
Corporation, +1-760-431-7080, info@imnr.com
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