Data Indicate That Whole-Inactivated HIV-1 Immunogen Induces HIV-Specific Immune Responses in HIV-Infected, HAART-Naive Patients; Final Data from IMNR.OB's Italian Study Presented in Poster at CROI Annual Meeting.CARLSBAD, Calif. -- The Immune Response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. Corporation (OTCBB OTCBB See OTC Bulletin Board (OTCBB). :IMNR) announced today that the final results from a Phase II clinical study indicate that the Company's whole-inactivated HIV-1 immunogen induces HIV-specific immune responses in HIV-infected, antiretroviral drug-naive patients. Specifically, this original formulation product showed potential to stimulate key immunologic parameters and to stabilize the loss of CD4+ cells, which could help prolong the time before these patients need to initiate antiretroviral therapy. The poster was presented at this week's 13th Conference on Retroviruses and Opportunistic Infections Opportunistic infections Infections that cause a disease only when the host's immune system is impaired. The classic opportunistic infection never leads to disease in the normal host. (CROI CROI Conference on Retroviruses and Opportunistic Infections ) in Denver. "CD4+ counts may be an especially important marker of disease progression and we plan to build on this data with our most potent clinical candidate, IR103," noted Joseph O'Neill, M.D., President and Chief Executive Officer of The Immune Response Corporation. "We have two ongoing clinical studies that will investigate IR103 in the drug-naive patient population. We will be expanding them and look forward to reporting the findings." The analysis included data from 49 patients that completed the study, and showed that median absolute CD4+ cell counts remained stable through week 28 in the patients that received three injections of the HIV-1 immunogen but declined in both the IFA Immunofluorescent assay (IFA) A blood test sometimes used to confirm ELISA results instead of using the Western blotting. In an IFA test, HIV antigen is mixed with a fluorescent compound and then with a sample of the patient's blood. and saline groups. The HIV-1 immunogen's effect on immune reconstitution was evidenced by an augmented production of factors known to reduce HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. replication, such as beta chemokines and alpha defensin. These data suggest a possible mode of action via boosting the body's own defense against HIV, which could play a role in delaying the initiation of antiretroviral therapy. The multi-center, single-blind, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. study followed a total of 51 patients over 28 weeks following treatment with the Company's patented HIV-1 immunogen, IFA or saline. Patients were antiretroviral-therapy naive and had HIV RNA HIV RNA AIDS RNA of HIV origin, a serum marker of a Pt's 'HIV-ness,' now the standard by which Pt response to antiretovirals is evaluated; HIV RNA levels correlate with CD4+ count, response to antiviral therapy, clinical stage and disease progression. levels between 10,000 and 40,000 copies/mL and CD4+ counts between 400 and 800 cells/uL at study entry. Patients received three injections of the HIV-1 immunogen (n=19), IFA (n=10), or saline (n=11) at weeks 0, 12, and 24. A fourth group received only a single injection of the HIV-1 immunogen at week 0 (n = 11). Although minor adverse events were reported, no treatment-limiting toxicities have been recorded to date. This trial was intended to explore the potential utility of the HIV-1 immunogen and was not designed to have enough statistical power to be used for regulatory approval. The Company is planning a clinical program that would use the data from this and other trials to design IR103 trials in the near future. The HIV-1 immunogen and IR103 are not approved by any regulatory agencies in any country at this time. About IR103 More than 25 million people have died since human immunodeficiency virus human immunodeficiency virus n. HIV. Human immunodeficiency virus (HIV) A transmissible retrovirus that causes AIDS in humans. (HIV) was first recognized in 1981 (source: UNAIDS UNAIDS Joint United Nations Programme on HIV/AIDS , December 2005), and the new infection rate continues to grow at an alarming rate. Despite medical advances, the worldwide pandemic pandemic /pan·dem·ic/ (pan-dem´ik) 1. a widespread epidemic of a disease. 2. widely epidemic. pan·dem·ic adj. Epidemic over a wide geographic area. n. 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 im·mu·no·gen·ic adj. Producing an immune response. immunogenic producing immunity; evoking an immune response. in extensive clinical studies of the Company's HIV-1 immunogen (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 immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to fight the virus. The Company recently completed the first part of a 49-patient Phase I/II five-arm, randomized, single-blind, controlled, multi-center clinical study of safety and bioactivity bi·o·ac·tiv·i·ty n. The effect of a given agent, such as a vaccine, upon a living organism or on living tissue. of IR103 in HIV patients on HAART HAART highly active antiretroviral therapy. HAART Highly active antiretroviral therapy, triple combination therapy AIDS The concurrent administration of 2 nucleoside reverse transcriptase inhibitors–eg, AZT and 3TC, and a protease (highly active antiretroviral therapy Noun 1. highly active antiretroviral therapy - a combination of protease inhibitors taken with reverse transcriptase inhibitors; used in treating AIDS and HIV drug cocktail, HAART ) at sites in the United Kingdom and Canada, and plans to report new data as they become available later this year. Preliminary results of this trial, reported last year, indicate that IR103 is safe, induces HIV-specific immune responses and greatly enhances IFN-gamma and RANTES RANTES Regulated on Activation Normal T Cell Expressed and Secreted mRNA. IFN-gamma and RANTES are considered immune system markers that give an estimate of the robustness of the immune response generated by IR103 in patients. The second part of this study, along with another similar study in Italy, will investigate IR103 as a first-line treatment for drug-naive HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines. These studies, which the Company plans to expand, will ultimately enroll over 200 drug naive patients. Along with tracking safety and measuring HIV-specific immune responses, these studies will assess IR103's ability to affect patients' CD4+ counts. CD4+ count is a critical marker of HIV disease progression that is used, along with viral load viral load n. The concentration of a virus, such as HIV, in the blood. viral load, n a measure of the number of virus particles present in the bloodstream, expressed as copies per milliliter. , to determine when a patient should begin antiretroviral therapy. The Company believes an immune-based therapy that could stabilize CD4+ counts could be used to delay initiation of antiretroviral therapy and serve as an important advance in the treatment of HIV. Final data from a drug-naive patient Phase II Italian study of REMUNE(R) showed that median absolute CD4+ cell counts of patients that received three injections of the Company's first generation immunotherapy remained stable through week 28, while declining in patients in the placebo groups. The Company believes that the increased potency of IR103 could translate to a more durable and pronounced effect on CD4+ counts. About The Immune Response Corporation The Immune Response Corporation (OTCBB: IMNR.OB) 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 multiple sclerosis (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 TCR T cell receptor. ) peptide technology, has shown potential clinical value in the treatment of relapsing forms of 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 Autoimmune diseases A group of diseases, like rheumatoid arthritis and systemic lupus erythematosus, in which immune cells turn on the body, attacking various tissues and organs. Mentioned in: Complement Deficiencies, Premature Menopause such as rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. (RA), psoriasis and Crohn's disease. In addition to MS, the Company has open Investigational New Drug Applications (IND) with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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. 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 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, 2004, 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. |
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