IMNR’s clinical trial program is testing IR103 in drug-naïve HIV-infected individuals with HIV infection who do not meet the criteria for antiretroviral therapy. The objective is to determine if IR103 can delay disease progression and extend the time to starting antiretroviral therapy, mimicking the effect seen in long term non-progressing patients.
IR103 is currently in two Phase II clinical trials with identical protocols. The two trials are known as IR111 (Canada/UK) and IR112 (Italy/France). The Phase I/II clinical trials began in 2004.
IMNR completed a 49-patient Phase I/II five-arm, randomized, single-blind, controlled, multi-center clinical study of safety and bioactivity of IR103 in HIV patients on HAART at sites in the United Kingdom and Canada. These data are expected to be reported at a medical meeting during 2006.
The Phase II part of this study tests IR103 as a first-line treatment for drug-naïve HIV-infected individuals that do not meet current antiviral drug guidelines. The primary endpoint of the study is an assessment of safety and immunology. Additional endpoints include CD4+ cell counts, viral load, and characterization of the pharmacological properties and therapeutic benefits.
IR103 Is Being Tested In Europe and Canada
In mid-June 2006, IMNR announced that it had completed the first stage of enrollment of 85 drug-naïve HIV patients in Italy and France. The patient enrollment included 31 patients who were returning from a previous trial and 54 newly enrolled patients. An additional 50 patients are scheduled to be enrolled by year-end 2006, bringing the total number in the trial to about 135 patients.
IMNR is running an identical Phase II trial in the United Kingdom and Canada that is expected to enroll an additional 100 patients in the UK. These two trials are expected to enroll over 230 patients.
IMNR expects to enroll about 200 patients in the two Phase II trials. The treatment is designed to be 52 weeks, so that treatment could be concluded by year-end 2007. An announcement would be expected of the results sometime during the first half of 2008.
HIV Preventive Program
Due to the significant need for a vaccine that could prevent HIV/AIDS, numerous public health organizations have made funding available. IMNR plans to submit grant and foundation applications to develop a preventive HIV vaccine and will not use its own funds. This program would use the IMNR’s patented whole-inactivated HIV antigen technology.
IMNR does not include any value for this program in their valuation.
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Any information regarding The Immune Response Corporation (”IMNR”) in this communication is neither an offer nor solicitation to buy or sell any securities mentioned. While we believe all sources of information to be factual and reliable, in no way do we represent or guarantee the accuracy thereof, nor the statements made herein. THE READER SHOULD VERIFY ALL CLAIMS AND DO ITS OWN DUE DILIGENCE BEFORE INVESTING IN ANY SECURITIES MENTIONED. ROI Group Associates, Inc. (”ROI”) is the investor relations counsel for IMNR and accepts compensation from the IMNR for this effort, including a monthly cash retainer and restricted stock. Under the terms of its investor relations Service Agreement, ROI has agreed not to sell any of the IMNR restricted stock received as compensation under the Service Agreement during the entire term of its engagement as IMNR’s investor relations counsel pursuant to this Service Agreement. ROI shall be under no obligation to update readers about any restrictions on its trading activities regarding IMNR.
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. Their lead immune-based therapeutic product candidates are NeuroVax™ for the treatment of multiple sclerosis (MS) and IR103 for the treatment of Human Immunodeficiency Virus (HIV). 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 IMNR’s patented T-cell receptor (TCR) peptide technology, has shown potential clinical value in the treatment of relapsing forms of MS. NeuroVax™ has been shown to stimulate strong disease specific cell mediated immunity in nearly all patients treated by enhancing levels of FOXP3+ T Regulatory (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, IMNR has opened Investigational New Drug Applications (IND) with the U.S. Food and Drug Administration (FDA) for clinical evaluation of TCR peptide-based immune-based therapies for RA and psoriasis. IR103 is based on their patented whole-inactivated virus technology, co-invented by Dr. Jonas Salk and indicated to be safe and immunogenic in extensive clinical studies of REMUNE® , our 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. IMNR 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. In early 2006 IMNR made a strategic decision to accelerate the development of IR103, rather than pursue a Phase III trial with REMUNE® . All of IMNR products are still in the development stage. IMNR has never had revenues from the sale of products. IMNR was founded in 1986.
Forward Looking Statement: This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. While these statements are meant to convey to the public the company’s progress, business opportunities and growth prospects, readers are cautioned that such forward-looking statements represent management’s opinion. While management believes such representation to be true and accurate based on the information available to the company, actual results may differ materially from those described. The company’s operations and business prospects are always subject to risks and uncertainties. Important facts that may cause actual results to differ are set forth in IMNR’s periodic filings with the U.S. Securities and Exchange Commission.
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IMNR — Immune Response Corp. (The)
5931 Darwin Court
Carlsbad, CA 92008
Website: http://www.imnr.com
Phone: 760-431-7080