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The Immune Response Corporation Announces That Phase II Preliminary Data Indicate Investigative HIV Immunotherapy IR103 Enhances Immune Responses in Antiretroviral Naive HIV-Infected Patients

Posted on: Monday, 26 June 2006, 09:00 CDT

Phase II Study Presented This Week at European HIV/AIDS Meeting in France

The Immune Response Corporation (OTCBB:IMNR) announced today that preliminary Phase II study results of its second-generation HIV immunotherapy, IR103, demonstrated a positive safety profile and enhanced immunomodulatory effects over REMUNE(R), the Company's first-generation immunotherapy. IR103 is a co-formulation of REMUNE(R) and a novel synthetic Toll-like receptor (TLR-9) agonist adjuvant, Amplivax(TM). The results were presented at the International Symposium on HIV & Emerging Infectious Diseases (ISHEID) in Toulon, France.

IR103 differs from currently available antiretroviral drug therapies in that it is an immune-based therapy designed to replenish and enhance key immune cells that have been destroyed by the virus, thus allowing stimulation of an HIV-infected individual's immune system to fight the virus. According to the most recent guidelines for the use of antiretroviral agents (ARV's) in HIV-1 infected adults and adolescents issued by the U.S. Department of Health and Human Services (DHHS - May 2006), initiation of ARV's is not recommended for asymptomatic patients with CD4+ T-cell count greater than 350 cells/mm3 (CD4+ count serves as a critical marker of HIV disease progression that is used, along with viral load, to determine immunocompetence in patients with HIV infection). In these patients, there is little evidence of the benefit in initiating ARV therapy due in part to toxicity risks and adherence challenges.

"The early results for IR103 in this clinical study are encouraging," said lead investigator, Andrea Gori, MD, of the Department of Internal Medicine and Surgery at San Paolo Hospital, University of Milan. "We can now proceed to further investigate the potential advance that IR103 may provide through its unique ability to actively stimulate an HIV patient's immune system to fight the virus."

Many studies indicate that CD8 T-cells are a critical component of the immune response which can control HIV. HIV-1 infected patients typically show a defect in T-cell maturation, leading to decreased levels of the 'effector memory' cells. It has been shown that people with HIV-specific CD8 T-cells that mature fully into 'effector memory' T-cells are able to control viral load after stopping ARV treatment. This study, examining 31 ARV-naive patients returning from a previous trial of REMUNE(R) (randomized to receive either REMUNE(R) or IR103 every 12 weeks for a total of 5 injections), demonstrates a shift towards the more mature T-cell subtypes, thus increasing numbers of the 'effector memory' cells that have been described as capable of destroying HIV. Preliminary 4 and 12 week data suggest that these changes may occur more rapidly and at greater magnitude in patients receiving IR103 compared to REMUNE(R). No safety issues were identified in any subjects through 12 weeks of evaluation.

The Company continues evaluating the clinical potential of IR103 to enhance immune response in patients. Another track of this Phase II study of IR103 completed the first stage of patient enrollment earlier this month and is designed to assess the safety and ability of various doses of IR103 to induce HIV-specific immunity, and also to measure changes in CD4 counts. The Company believes an immune-based therapy that stabilizes CD4 counts could be used to delay initiation of antiretroviral therapy and serve as an important advance in the treatment of HIV.

About IR103

More than 25 million people have died since human immunodeficiency virus (HIV) was first recognized in 1981 (source: UNAIDS, December 2005), and the new infection rate continues to grow at an alarming rate. Despite medical advances, the worldwide pandemic continues to claim more than 3.1 million lives each year (source: UNAIDS, December 2005). Additional safe and effective treatments are desperately needed.

IR103 is a second-generation HIV immunotherapy based on the Company's patented, whole-inactivated virus technology, which was co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE(R), the Company's first generation HIV product candidate. Preclinical research and recent clinical data show that IR103 is a more potent formulation that combines its whole-inactivated antigen with a synthetic Toll-like receptor (TLR-9) agonist to create enhanced HIV-specific immune responses. This product differs from currently available antiretroviral drug therapies since it is designed to stimulate an HIV-infected individual's immune system to fight the virus.

About The Immune Response Corporation

The Immune Response Corporation (OTCBB:IMNR) is an immuno-pharmaceutical Company focused on developing products to treat autoimmune and infectious diseases. The Company's lead immune-based therapeutic product candidates are NeuroVax(TM) for the treatment of MS and IR103 for the treatment of HIV infection. Both of these therapies are in Phase II clinical development and are designed to stimulate pathogen-specific immune responses aimed at slowing or halting the rate of disease progression.

NeuroVax(TM), which is based on the Company's patented T-cell receptor (TCR) peptide technology, has shown potential clinical value in the treatment of relapsing forms of multiple sclerosis (MS). NeuroVax(TM) has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all patients treated and appears to work by enhancing levels of FOXP3+ Treg cells that are able to down regulate the activity of pathogenic T-cells that cause MS. Increasing scientific findings have associated diminished levels of FOXP3+ Treg cell responses with the pathogenesis and progression of MS and other autoimmune diseases such as rheumatoid arthritis (RA), psoriasis and Crohn's disease. In addition to MS, the Company has open Investigational New Drug Applications (IND) with the FDA for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis.

IR103 is based on the Company's patented, whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE(R), the Company's first generation HIV product candidate. IR103 is a more potent formulation that combines its whole-inactivated antigen with a synthetic Toll-like receptor (TLR-9) agonist to create enhanced HIV-specific immune responses. The Company is currently testing IR103 in two Phase II clinical studies as a first-line treatment for drug-naive HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines.

NeuroVax(TM) and IR103 are in clinical development by The Immune Response Corporation and are not approved by any regulatory agencies in any country at this time. Please visit The Immune Response Corporation at www.imnr.com.

Amplivax(TM) was developed by Idera Pharmaceuticals and has been licensed to The Immune Response Corporation.

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 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 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 NeuroVax(TM) or IR103 in preclinical trials and/or earlier clinical trials. A more extensive set of risks is 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, 2005, and its subsequent Quarterly Reports filed 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.

Source: Business Wire

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