HEB Keeps Going Strong...News
New Animal Model for Evaluating Antiviral Agents Against the SARS Virus Indicates Potential Effect of Ampligen(R), an Experimental Therapeutic
Independent University Researchers Find Ampligen(R) "Fully Protective" in Study
globenewswire
Companies:
o Hemispherx Biopharma, Inc.
Press Release Source: Hemispherx Biopharma, Inc. On Monday February 8, 2010, 8:45 am
PHILADELPHIA, Feb. 8, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company") reported a recent study, published in the December 20th issue of Virology (2009) by a consortium of researchers at Utah State University and the University of North Carolina, on a newly developed animal model of severe acute respiratory disease syndrome (SARS) which, according to the authors, " ... largely mimicked human disease". SARS emerged in 2002 in the Guangdong province of Southern China as a new infectious respiratory disease characterized by influenza-like symptoms with a very high mortality rate. The researchers characterized and adapted a new strain of the SARS virus (SARS-CoV) to mice that was 100% lethal and was associated with the overproduction of cytokines and severe lung pathology (Day CW, et al. Virology, 395:210-222, 2009).
Multiple agents with purported antiviral activity were evaluated for activity in this unique mouse model of the human disease, including Ampligen® (Poly I : Poly C12U), ribavirin (a commercially available antiviral with multiple modes of action for certain respiratory diseases) and other experimental agents. The researchers found that, uniquely among the agents tested, Ampligen®, an experimental therapeutic, " ... protected against death and gross damage to the lungs in the presence of lethal SARS-CoV" and was associated with a reduction in IL-6 concentration in which high levels of the cytokine correlated with the mortality of SARS-CoV infection. Mortality was high, under the conditions tested, for all the other antiviral agents examined, including ribavirin, that have previously been used extensively in humans with SARS without definitive evidence of efficacy (Stockman LJ, et al. PLoS Med 3 (9),e 343).
To date, there are no approved agents for treating SARS. Animal experiments do not necessarily predict safety or efficacy in man. Encouraged by these results, Hemispherx is now in discussions with Chinese clinical research organizations to institute clinical antiviral programs in China.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx's flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon LDO. Ampligen® represents experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties, including, but not limited to, the risk that the results of the animal studies are not representative of the safety or efficacy profile of Ampligen® when used as a treatment in humans and the risk that we are not able to come to an agreement to institute a clinical antiviral program in China or elsewhere in connection with the use of Ampligen® as a treatment for SARS. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Contact:
Hemispherx Biopharma, Inc.
Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
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