"We are excited that REMUNE(R) has been chosen for this important study which is designed to observe the effects of therapy in early stages of the disease. REMUNE(R) is the only immune-based therapy to be studied in this trial," said John N. Bonfiglio, Ph.D., President and Chief Executive Officer of The Immune Response Corporation. "We are pleased that previous demonstrations of the ability of REMUNE(R) to induce strong new immune responses have led to its inclusion in this trial."
The Immune Response Corporation's REMUNE(R) is an immune-based therapy in development to treat individuals infected by the human immunodeficiency virus (HIV). REMUNE(R) is different from currently available antiretroviral drug therapies since it is designed to stimulate an HIV-infected individual's immune system to attack HIV. The Company believes that results of previous clinical trials demonstrate that REMUNE(R) boosts HIV-specific immune responses and has the potential to slow the progression of HIV infection when used alone or in conjunction with antiretroviral therapy. Furthermore, the Company believes that REMUNE(R) stimulates the production of specific immune system modulators (cytokines and chemokines) that naturally protect components of the immune system from HIV infection.
"While we have previously studied REMUNE(R) in both ART-naive HIV-infected patients and in HIV patients on ART, we believe REMUNE(R) may also be able to boost HIV-specific immune responses in patients with early stage HIV infection," said Georgia Theofan, Ph.D., Vice President of Clinical Development at The Immune Response Corporation. "Our own clinical program is expanding to include additional studies in ART-naive patients with both REMUNE(R) and IR103, our newest HIV product candidate."
REMUNE(R) is in Phase II clinical trial development by The Immune Response Corporation and is not approved by any regulatory agencies in any country at this time.
About the NIH HIV Study
The U.S. National Institutes of Health (NIH) has funded a five-year randomized, controlled clinical trial investigating antiretroviral therapy (ART) alone versus ART with a therapeutic HIV immunization (REMUNE(R)), both including monitored treatment interruptions, in acute and recently HIV-infected subjects. The study will ultimately enroll 92 patients who will receive currently marketed ART drugs for the first 48 weeks of the study followed by administration of REMUNE(R) or placebo every 12 weeks for an additional 36 weeks. Patients will also undergo structured treatment interruptions following immunization, and will be followed for a minimum of three years. All patients will be followed with multiple immunologic tests in vitro. The trial will be conducted at NYU Medical Center and the University of Montreal/McGill University AIDS program.
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. 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.