The purpose of a therapeutic vaccine for HIV is to bolster the immune system to more effectively mount a sustained attack against HIV-infected cells. This may be accomplished by allowing the body to create and maintain a memory of the core proteins making up the virus by exposing it to an inactivated form of HIV that could not infect or destroy the immune cells. In order to create this vaccine candidate, cells chronically infected with the virus require growth and expansion in large quantities. The resulting whole virus contained in the clarified production medium is then inactivated and further purified through a scientifically robust and strictly regulated process.
The Company has collaborated with Irvine Scientific, a leading medical device/biotechnology company located in Santa Ana, CA, to develop a chemically defined, serum-free cell culture medium for the production process that eliminates all animal-derived components, improves viral yield, and is designed to provide consistently high cell growth through to full-scale production, while maintaining the performance of the final vaccine product as an immunological stimulant against HIV.
“The progress reported at this conference represents a significant advance for the Company,” said Peter Lowry, Vice President of Manufacturing Operations at The Immune Response Corporation. “This new serum-free medium greatly enhances our ongoing efforts toward an efficient, economically viable, and reproducible manufacturing process that will allow us to produce safe and consistent whole-inactivated viral vaccines in large quantities.”
Through a process of screening and optimization, the Company demonstrated that the human T-cell lymphoma cell line HUT-78 (chronically infected with HIV-1) can be grown and reliably passaged in a chemically-defined cell culture medium, with cell densities exceeding two million cells/ml. In addition, initial HIV-1 viral antigen yields were improved at least two-fold over the serum supplemented medium originally used.
The Company believes that, in parallel with the continuation of the IR103 Phase II clinical program, this new medium represents a valuable step in the development of an economically sound and transferable manufacturing process for the vaccine in the future.
REMUNE(R) is a registered trademark of The Immune Response Corporation. NeuroVax(TM) is a trademark of The Immune Response Corporation.
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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Sources:
IMNR — Immune Response Corp. (The)
5931 Darwin Court
Carlsbad, CA 92008
Website: http://www.imnr.com
Phone: 760-431-7080
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