- Phase I/II Clinical Trial Discontinued Early After 94 Percent of Patients
Show Response -
- Results Presented at American Academy of Neurology -
CARLSBAD, Calif., April 29 /PRNewswire-FirstCall/ -- The Immune Response
Corporation (Nasdaq: IMNR), a biopharmaceutical company developing
immune-based therapies (IBT) for HIV and select other diseases, today
announced that its investigational T-cell receptor (TCR) peptide vaccine,
NeuroVax(TM), produced a peptide-specific immune response in 94 percent of the
patients treated in a Phase I/II clinical trial in multiple sclerosis.
Results of the three-armed, randomized trial, which was discontinued early
when an interim analysis revealed the high rate of response, were presented
yesterday at the 54th annual meeting of the American Academy of Neurology
(AAN) held in San Francisco, CA.
Earlier clinical research on immunotherapy for multiple sclerosis
suggested that only about half of patients had an immune response to treatment
with a single TCR peptide but that this reaction probably had clinical
benefit. 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.
"The surprisingly high immunogenic response to NeuroVax(TM), both in the
percentage of patients responding and in the strength of their responses,
validates this new approach to enhancing TCR peptide immunization and suggests
that we may finally be able to more specifically regulate the pathogenic
T-cells thus addressing the underlying causes of the disease," said Dennis N.
Bourdette, MD, Chairman of the Department of Neurology at Oregon Health &
Science University in Portland, Ore., and lead investigator for this study.
"Patients with multiple sclerosis currently have few treatment options. Our
research is continuing to determine if the active immune response to
NeuroVax(TM) correlates with a clinically relevant impact on disease
progression."
In the study, 37 patients were randomized to receive either the three TCR
peptides with saline (15 patients), the NeuroVax(TM) combination (16
patients), or adjuvant alone (6 patients). Patients received monthly
injections for 24 weeks, and the induction of TCR peptide-specific T-cell
responses was measured against baseline to gauge immune response. Using an
intent-to-treat analysis, the proportion of patients who were TCR vaccine
responders was significantly greater (p<0.001) in the NeuroVax(TM) group, with
15/16 (94 percent) responding patients compared with 1/15 (7 percent) for the
TCR/saline group and 0/6 for the adjuvant group.
"With 94 percent of patients showing a disease-specific immune response in
this study, we will continue to pursue development of NeuroVax(TM) in multiple
sclerosis as both a monotherapy and in combination with currently approved
treatments," said John N. Bonfiglio Ph.D., Chief Executive Officer of
The Immune Response Corporation. "NeuroVax(TM) is another example of how
immune-based therapies pioneered by The Immune Response Corporation's
co-founder, Dr. Jonas Salk, may provide a promising new mechanism for fighting
difficult diseases. Together with our product candidates for HIV -- REMUNE(R)
and IR103 -- I believe our pipeline is making the progress necessary to
eventually commercialize products to meet patient needs in two underserved
areas."
NeuroVax(TM) was well tolerated over the 24 weeks of therapy. There were
no serious side effects reported, and the only adverse events attributable to
NeuroVax(TM) were injection-site reactions.
Multiple sclerosis 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 the loss of a fatty tissue
called myelin that surrounds and protects nerve fibers, creating scarring
(sclerosis) that interferes with the normal transmission of nerve impulses.
This, in turn, leads to a variety of highly individual and unpredictable
neurological symptoms, ranging from movement and balance problems to vision
impairment. It is believed that a subset of the specific class of white blood
cells, CD4+ T-cells, that normally plays an important role in the immune
system, somehow becomes autoreactive and is principally responsible for the
progression of the disease. TCR peptides have been shown to stimulate
regulatory T-cells capable of suppressing the autoreactive CD4+ T-cells in a
certain proportion of patients. NeuroVax(TM), which combines three TCR
peptides with an adjuvant, was designed to increase the likelihood of this
immune reaction.
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 treatment for people
with 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
About OHSU
Oregon Health & Science University, located in Portland, Ore., includes
the schools of dentistry, medicine, nursing and science and engineering; OHSU
Hospital and Doernbecher Children's Hospital; numerous primary care and
specialty clinics; multiple research institutes; and several outreach and
community service units.
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.
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
AT OHSU:
Jonathan Modie, media relations coordinator
503-494-8231
modiej@ohsu.edu
SOURCE The Immune Response Corporation
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Related links:
http://www.imnr.com
CONTACT:
Media, Laura Silver, Corporate Communications
of Sam Brown Inc., +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; or Jonathan Modie, media
relations coordinator of OHSU, +1-503-494-8231, modiej@ohsu.edu
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