- Company Plans to Accelerate NeuroVax(TM) Clinical Program in
Response to Encouraging Preliminary Results -
CARLSBAD, Calif., July 1 /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 data on the Company's MS treatment, NeuroVax(TM), was presented
yesterday at the 14th meeting of the European Neurological Society (ENS) in
Barcelona, Spain. New NeuroVax(TM) data from an ongoing Phase II open-label
study continues to demonstrate overall immunological activity and, for the
first time, that NeuroVax(TM) may directly induce regulatory T-cells, thought
to play an important role in the modulation of MS. These new results were
presented along with previously presented Phase I/II data from a blinded trial
concluded earlier this year.
"We are encouraged that this very early data from the open-label trial
replicates the strong disease-specific immune responses we have seen in other
NeuroVax(TM) studies. In fact, it has encouraged us to accelerate the
NeuroVax(TM) clinical program and we are now planning to initiate a new
NeuroVax(TM) trial," said John N. Bonfiglio Ph.D., Chief Executive Officer of
The Immune Response Corporation. "The MRI data presented earlier this year
suggest immune responses stimulated by NeuroVax(TM) may yield clinical benefit
for MS patients. We are looking forward to designing a trial that will
augment our understanding of NeuroVax(TM)'s clinical utility."
The ongoing open-label trial, preliminary results from which were
presented at ENS yesterday, will ultimately enroll 40 MS patients and is
designed to assess several immunological endpoints, as well as collect some
magnetic resonance imaging (MRI) follow-up on returning patients from the
blinded study. Of the 21 patients currently enrolled, 11 were tested for
overall immunogenicity and all 11 exhibited a strong immune response to
NeuroVax(TM). Additionally, a regulatory T-cell assay was conducted in nine
of these patients and four showed significant enhancement of baseline levels
of regulatory T-cells.
Earlier this year, the Company presented data demonstrating that
NeuroVax(TM) produced a peptide-specific immune response in 94 percent of the
patients treated in a Phase I/II clinical trial in MS. Results of this
three-armed, blinded randomized trial, which was discontinued early when an
interim analysis revealed the high rate of response, were presented in April
at the 54th annual meeting of the American Academy of Neurology (AAN) held in
San Francisco, CA. NeuroVax(TM) is composed of a combination of TCR peptides
from three families (BV5S2, BV6S5, and BV13S1) with an adjuvant to improve
immune response rates. While the study was not designed to evaluate clinical
benefit, the investigators observed a trend favoring decreased MRI activity,
an important diagnostic marker for MS, among patients who responded to
NeuroVax(TM) immunologically.
A recent grant, awarded by the Immune Tolerance Network (ITN), an
international research consortium, to Oregon Health Sciences University (OHSU)
is being used to fund the open-label trial of NeuroVax(TM) at OHSU under an
IND held by The Immune Response Corporation. Under the grant, the ITN is
providing funding and technical support for additional immunological assays to
be performed as part of the trial that will investigate the mechanisms of
action of NeuroVax(TM) and seek to establish additional endpoints for
therapeutic efficacy.
Multiple sclerosis (MS) is an autoimmune disease in which the immune
system, the body's principal defense against foreign substances such as
bacteria, mistakenly attacks normal tissues of the central nervous system. It
afflicts approximately 400,000 people in the United States and more than
2.5 million worldwide. Specifically, the disease results in damage to a fatty
tissue called myelin that surrounds and protects nerve fibers, creating
scarring (sclerosis) that interferes with the normal transmission of nerve
impulses. This damage in turn leads to a variety of chronic and highly
individual and unpredictable neurological symptoms, ranging from movement and
balance problems to vision impairment. The disease is largely caused by
activation of a specific subset of the patient's own white blood cells,
T-cells that then attack the myelin and are largely responsible for disease
progression. The Company postulates that TCR peptides with Incomplete
Freund's Adjuvant (IFA) stimulate regulatory T-cells capable of suppressing
these autoreactive pathogenic T-cells. NeuroVax(TM), which combines three TCR
peptides with IFA, was designed to increase the likelihood of this immune
reaction.
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
immune-based therapy, IR103, which incorporates a second-generation
immunostimulatory oligonucleotide adjuvant.
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 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.
NeuroVax(TM) is a trademark of The Immune Response Corporation. REMUNE(R)
is a registered trademark of The Immune Response Corporation.
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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