IMNR – The Immune Response CorporationImportant Phase IIb Trials Set to Begin for MS Treatment – NeuroVax NeuroVax Phase IIb clinical trial is scheduled to begin in early Fall 2006. The trial is designed as a double-blind, placebo controlled study and is expect to enroll about 200 treatment naïve patients in Eastern Europe. In early clinical testing, NeuroVax has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all patients treated. 3Q:06. There are currently several approved therapeutics for the treatment of MS. These treatments have been shown (1) to reduce annual relapse rates and (2) reduce incidence of new inflammation in the brain, as measured by MRI activity (used to measure and quantify the size and number of new brain lesions) in about 50% of the patients treated. The chronic, progressive nature of MS requires patients to be on therapy from diagnosis until death. Demand for Multiple Sclerosis Therapies Only about half of all Multiple Sclerorsis patients are taking therapy. This is attributed to the side effects that can lead to patients dropping off therapy. The most common problems are intolerance to side effects, frequent administration, and development of antibodies that neutralize the drug. In spite of these problems, multiple sclerosis therapeutic sales in the US and Europe reached $4.5 billion in 2004. Approximately 50% of multiple sclerosis global sales were derived from the U.S. ($2.3 billion) in 2004, with the remainder largely derived in Europe ($2.2 billion). Immune Response were the first to establish a relationship between the immune cell marker FOXP3 expression and Tcell regulation in MS. The diminished levels of cells expressing the FOXP3 marker upsets the balance between the regulatory cells and the autoreactive cells, allowing the autoreactive cells to proliferate and cause the clinically observed symptoms known as exacerbations. NeuroVax has been shown to increase the levels of the regulatory T-cells that express the FOXP3 marker at levels seen in healthy controls. This could potentially restore the balance between suppression and activation, keeping the pathogenic cells from proliferating and causing exacerbations. In early clinical testing, NeuroVax has been shown to stimulate strong, disease-specific cell-mediated immunity in nearly all patients treated. IMNR Manufacturing Facilities In Our Next Post. 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. Disclosure: Pentony Enterprises LLC was compensated $17,500 from ROI Group Associates Inc. for profile coverage. Pentony Enterprises LLC is not a registered investment advisers or broker/dealers. Pentony Enterprises LLC makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person or that an investment such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk. Disclosure: StockGuru.com is owned and operated by Pentony Enterprises LLC, 9555 Lebanon Road, Suite 103, Frisco, Texas 75035. Telephone: (214) 453-4258. Web: StockGuru.com. Email: http://www.stockguru.com/blog/Publisher@Stockguru.com. For further information contact: ROI Group Associates 39 Broadway; NY, NY 10006 212.495.0744 abrown@roiny.com Source: IMNR — Immune Response Corp. (The) 5931 Darwin Court Carlsbad, CA 92008 Website: http://www.imnr.com Phone: 760-431-7080
StockGuru Blog: The Immune Response Corporation – Multiple Sclerosis Important Advancements Phase IIb Clinical Trials Scheduled
July 22, 2006 at 11:36am
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