- Safety and Ability to Generate HIV-Specific Immune Reponses to be
Investigated -
CARLSBAD, Calif., June 15 /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 today that Health Canada has cleared its first clinical trial
investigating IR103, the Company's newest product candidate in development for
the treatment of HIV. This trial will represent the first human experience
with the Company's new HIV product candidate, IR103, which combines its
patented HIV-1 Immunogen with Amplivax(TM), an immunostimulatory
oligonucleotide adjuvant.
"The commencement of this trial represents a major milestone in the
Company's development plan for its HIV products. The recent laboratory data
we presented on IR103 has encouraged us to pursue clinical trials with this
product candidate as quickly as possible," said John N. Bonfiglio, Ph.D.,
Chief Executive Officer of The Immune Response Corporation. "Clearance of our
trial in Canada is an important first step in evaluating IR103 in humans. In
addition to this trial in patients currently on antiretroviral therapy, we
will be studying IR103 in drug-naive patients later this year. I am proud of
the effort by our team in getting this important study underway."
The Canadian trial will begin enrolling volunteers in the next few weeks.
Two additional sites in the United Kingdom will commence when the Company
receives clearance from the UK Medicines and Healthcare Products Regulatory
Agency (MHRA).
The two-part, nine-arm, randomized, single-blind, controlled, multi-center
phase I/II study will commence this summer and will run for approximately 28
weeks with 80 patients enrolled. The primary objective of this study is to
evaluate safety and bioactivity or the ability to generate HIV-specific immune
responses to IR103, a therapeutic HIV vaccine consisting of a whole-killed
HIV-1 antigen combined with an immunostimulatory oligonucleotide adjuvant
(Amplivax(TM)), with or without Incomplete Freund's Adjuvant (IFA), in HIV
patients on HAART (highly active anti-retroviral therapy). Ability to
generate HIV-1 specific immune responses is thought to be an important
indicator of clinical utility.
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 (IBT) 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;
or investors, 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
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