First HIV Patients Enrolled in New International Trial
CARLSBAD, Calif., Sept. 10 /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,
announced today the first patients have been enrolled at the Canadian site in
its initial clinical trial investigating IR103, the Company's newest product
candidate in development for the treatment of HIV. This trial, with active
sites in the United Kingdom and Canada, will represent the first human
experience with IR103, which combines the Company's patented HIV-1 Immunogen
with Amplivax(TM), an immunostimulatory oligonucleotide adjuvant.
"Our preclinical research has shown results that suggest the combination
of our HIV-1 Immunogen with Amplivax(TM) in IR103 elicits a strong immune
response. We believe this type of response will be replicated in human
subjects by IR103. We are delighted to advance IR103 into its first clinical
study formally initiating a development plan designed to carefully examine
this important product candidate," said John N. Bonfiglio, Ph.D., Chief
Executive Officer of The Immune Response Corporation. "Further, the UK
Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared our
protocol and we plan to be enrolling patients in the UK shortly."
The two-part, nine-arm, randomized, single-blind, controlled, multi-center
phase I/II study began 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, 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.
For more information about enrolling in this trial please contact The
Immune Response Corporation at 760-431-7080 in the United States.
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 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 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.
NOTE: 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 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, or
silver@sambrown.com, for The Immune Response Corporation; or
investor relations, Kathy Waller of Financial Relations Board,
+1-312-266-7800, or kwaller@financialrelationsboard.com, for The
Immune Response Corporation; or Michael K. Green, Chief Financial
Officer of The Immune Response Corporation, +1-760-431-7080, or
info@imnr.com
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