- Interim Results From Study in Italy in Drug-Naive HIV Patients Presented at
HIV Meeting -
CARLSBAD, Calif., Sept. 14 /PRNewswire-FirstCall/ -- An investigational
treatment, REMUNE(R) (HIV-1 Immunogen), induces HIV-specific immunity in
drug-naive patients according to interim results from an ongoing multi-center
Phase II study conducted in Italy and presented by Renato Maserati, MD, at the
Immunomodulating Drugs for the Treatment of HIV conference in Lake Garda,
Italy. REMUNE(R) is being developed by The Immune Response Corporation
(Nasdaq: IMNR), a biopharmaceutical company dedicated to becoming a leading
immune-based therapy company in HIV and multiple sclerosis.
"Although the Italian study is ongoing, these interim data show REMUNE(R)
induces an HIV-specific immune response in antiretroviral naive subjects and,
therefore, the hope that enhanced immunity may delay disease progression,"
said John N. Bonfiglio, Ph.D., Chief Executive Officer of The Immune Response
Corporation. "With guidelines recommending delayed intervention for newly
diagnosed HIV patients based on CD4 and viral load counts, an immune-based
therapy like REMUNE(R) that could possibly delay initiation of antiretroviral
therapy (ART) would be an important advance in the treatment of HIV. So far
the results are tracking with our expectations based upon our knowledge of the
therapy. We expect these data to be pivotal in our choice of design for
registration trials."
The interim analysis showed that subjects receiving three injections of
REMUNE(R) had a significantly higher level of HIV-specific CD4-positive and
CD8-positive memory T cells than control subjects receiving Incomplete
Freund's Adjuvant (IFA) or saline, suggesting that REMUNE(R) can induce the
type of immune responses that could be clinically important. There were no
significant changes in CD4 cell count or viral load in any of the study groups
through week 12 as was expected due to the length and design of the trial.
"We were impressed with REMUNE(R)'s effect on HIV-specific immune
responses in drug-naive subjects seen in this study," said Georgia Theofan,
PhD, Vice President of Clinical Development at The Immune Response
Corporation. "We are looking forward to the final analysis from this study at
the end of the year. We also plan to rollover these subjects into a trial
with IR103 designed to be completed next year."
The multi-center, single-blind, randomized study investigated 50 subjects
over 28 weeks following treatment with REMUNE(R), IFA or saline. The study
had two patient groups treated with either one or three injections of
REMUNE(R) and each of the other arms received three injections of either IFA
or saline. The four arms of the study each received injections at weeks 0,
12 and 24; with all subjects completed through week 12 and a subset of
30 subjects completed through week 28. A rollover study to IR103, which
combines REMUNE(R) with Amplivax(TM), an immunostimulatory oligonucleotide
adjuvant, is planned.
REMUNE(R) is in Phase II development by The Immune Response Corporation
and is not approved by any regulatory agencies in any country at this time.
Dr. Maserati has served as a clinical investigator to The Immune Response
Corporation and has received research funding support from the company.
Amplivax(TM) was developed by Hybridon, Inc. (Amex: HBY) 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 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 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.
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
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 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
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