Stockguru has highlighted The Immune Response Corporation for over a week. We thought you might be interested in understanding why a vaccine is a breakthrough concept in the treatment of HIV/AIDS.
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 Immune Response Corporation announced the development of a serum-free, chemically defined cell culture medium for the production of HIV-1 from HUT-78 cells, a human T-cell lymphoma cell line.
The development of this medium is an important step in the development of a vaccine utilizing whole-inactivated HIV to stimulate the human immune system against the virus. The Immune Response Corporation is currently evaluating this approach for a therapeutic vaccine in clinical trials of its second-generation HIV immunotherapy IR103. This technology will also be utilized toward the development of a preventive vaccine candidate.
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 Immune Response Corporation has collaborated with Irvine Scientific, a medical device and biotechnology company located in Santa Ana, California, 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.
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.
IMNR believes that, in parallel with the continuation of the IR103 phase 2 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.
About The Immune Response Corporation: IMNR 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 multiple sclerosis (MS) and IR103 for the treatment of HIV infection.
Forward Looking Statements: 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, 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 to-day 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.
Source:
Managed Care Law Weekly via LawRx.com
To Access IncreMental Advantage research report CLICK HERE: http://www.roiny.com/clients-irc-research.php.
For additional information, please email ROI Group Associates at imnr@roiny.com or call Mike Dodge at 212-495-0744.
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.
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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Source:
IMNR — Immune Response Corp. (The)
5931 Darwin Court
Carlsbad, CA 92008
Website: http://www.imnr.com
Phone: 760-431-7080