The Immune Response Corporation Completes First Stage of Enrollment and Receives Approval for Expansion of Phase II Trial for Investigative HIV Immunotherapy IR103
Carlsbad, California – June 19, 2006 – The Immune Response Corporation (OTCBB: IMNR.OB) announced today the completion of the first stage of enrollment of drug-naïve HIV patients in a Phase II clinical study being conducted in Italy. The study, which has enrolled a total of 31 returning patients from a previous trial and 54 new patients, will examine IR103, a second generation immunotherapy, as a first-line treatment for drug-naïve HIV-infected individuals not yet recommended for antiretroviral therapy according to current medical guidelines. In addition, approval has been obtained for expansion of the study to include an additional 50 patients, and enrollment of the additional patients has begun. Ultimately over 200 drug-naïve patients will be enrolled in two parallel studies with sites in Italy, France, Canada and the UK.
The study, which includes a rollover patient population from a previous clinical study of the Company’s first generation immunotherapy, REMUNE®, is designed to assess the safety and ability of various doses of IR103 to induce HIV-specific immunity. The trial will also measure changes in CD4+ counts, a critical marker of HIV disease progression that is used, along with viral load, to determine when a patient should begin antiretroviral therapy. 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.
“We are very encouraged by the rapid recruitment of patients in Italy in the IR103 study,” said Georgia Theofan, Ph.D., Vice President of Clinical Development of The Immune Response Corporation. “We are looking forward to the expansion and enrollment of additional patients in Europe as we continue generating data on our second generation immune-based therapy for HIV in this important patient population.”
For more information about enrolling in this trial please contact The Immune Response Corporation at 760-431-7080 in the United States.
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®, 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.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™ 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™, 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). Neuronal™ 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®, 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-naïve HIV-infected individuals not yet eligible for antiretroviral therapy according to current medical guidelines.
NeuroVax™ 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.
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 NeuroVaxTM 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 NeuroVaxTM 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 NeuroVaxTM 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® is a registered trademark of The Immune Response Corporation. NeuroVaxTM is a trademark of The Immune Response Corporation.
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- The Immune Response Corporation
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