CARLSBAD, Calif., Feb. 27 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (Nasdaq: IMNR) announced today that an interim analysis by the
Company of their Phase I/II clinical study of NeuroVax(TM) in Multiple
Sclerosis ("MS") confirmed that the primary endpoint had been met (p=0.0004).
The interim analysis of the primary endpoint was performed according to an a
priori definition of responder. A total of 20 subjects were included in the
interim analysis that compared responses to peptides in Incomplete Freund's
Adjuvant ("IFA") (8 subjects), peptides in saline (8 subjects) and IFA alone
(4 subjects). The group of subjects receiving intramuscular injections of
peptides in IFA (NeuroVax(TM)) demonstrated a statistically significant
response as compared to the group receiving intradermal injections of peptides
in saline or the group receiving IFA alone. Based on these statistically
significant results and after discussion with the principal investigator,
Dennis Bourdette, M.D., Oregon Health Sciences University, the company plans
to amend the trial protocol to allow all participants currently enrolled to
receive NeuroVax(TM). The company plans to discuss these results with the FDA
regarding the design of the next trial.
"This is an important milestone in the development of T cell receptor
peptide therapy. We finally have early clinical study indications of a
vaccine candidate that may boost natural regulatory T cells in most, if not
all, of the patients. It is gratifying to observe just how vigorous the
responses were in all of the patients injected with NeuroVax(TM). These
results will allow us to potentially move forward much more quickly to design
and conduct an efficacy trial," said Arthur Vandenbark, Ph.D., Portland VA
Medical Center, co-inventor of the technology.
The Phase I/II study was designed as a multicenter, three arm randomized
24-week study examining the effect of T cell receptor ("TCR") peptides in
treating individuals with MS. T cells specific for antigens in the central
nervous system are thought by scientists to be involved in the auto-reactive
immune response in MS patients, which may lead to over-expression of certain
T cells particularly BV5S2, BV6S5 and/or BV13S1. The purpose of immunization
was specific activation of regulatory T cells that are capable of down-
regulating the over-expressed auto-reactive T cells. The objective of the
study was to confirm the established safety profiles of both NeuroVax(TM) and
the mixture of the three peptides in saline, assess the ability to increase
anti-inflammatory immune responses and to determine the optimal formulation of
TCR peptides by comparing them to an adjuvant alone group (IFA). One arm
included a formulated mixture of three distinct peptides emulsified in IFA
(NeuroVax(TM)), another arm included the same peptides formulated in saline,
and both of these arms were compared to IFA alone. A total of 25 patients
were to be enrolled in each of the peptide arms and 10 in the adjuvant control
arm. The primary endpoint for this study was the frequency of patients
responding immunologically to the BV5S2, BV6S5 and/or BV13S1 peptides.
Immunological responsiveness was determined using a limiting dilution assay
(LDA) to these three peptides.
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: 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 clinical trials will be successfully
concluded and whether NeuroVax(TM) 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
Forms 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.
NeuroVax(TM) is a registered trademark of The Immune Response Corporation.
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
Company News On-Call:
http://www.prnewswire.com/comp/434675.html
CONTACT:
Investors, Kathy Lane of The Immune Response
Corporation, +1-760-771-2236
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