Business Wire - June 1, 2005
"We believe IR103 will demonstrate similar results to those we've seen in the REMUNE(R) trials with drug-naive HIV patients, such as the one recently completed in Italy. Current guidelines recommend delaying HAART treatment in newly diagnosed HIV patients, in part because current treatments are so toxic," said John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation. "IR103 and REMUNE(R) may fill this gap by providing an efficacious and safe therapy in these early stages of the disease."
The randomized, single-blind, controlled, multi-center Phase I/II study began in 2004 and will follow patients for 28 weeks. The primary objective of this study is to evaluate safety and bioactivity, or the ability to generate HIV-specific immune responses to IR103, in HIV patients with and without HAART. Ability to generate HIV-specific immune responses is thought to be an important indicator of clinical utility.
IR103 combines the Company's patented HIV-1 immunogen with Amplivax(TM), an immunostimulatory oligonucleotide adjuvant. 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 company in HIV and 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. We have initiated development of a new immune-based therapy, IR103, which incorporates a second-generation immunostimulatory oligonucleotide adjuvant and is currently in Phase I/II clinical trials in Canada and the United Kingdom.
The Immune Response Corporation is also developing an immune-based therapy for MS, NeuroVax(TM), which is currently in Phase II clinical trials and has shown potential therapeutic value for this difficult-to-treat disease.
Please visit The Immune Response Corporation at 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, 2004, 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. Amplivax(TM) is a trademark of Hybridon, Inc.
CONTACT: The Immune Response Corporation
Michael K. Green, 760-431-7080 (Investors)
info@imnr.com
or
Sam Brown Inc. Corporate Communication
Laura Silver, 310-551-9940 (Media)
silver@sambrown.com
SOURCE: The Immune Response Corporation
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