PHILADELPHIA, Oct. 18, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced that its collaborative partner, Japan's National Institute of Infectious Diseases (JNIID), has published an article in The Journal of Infectious Diseases (2007:196 (1 November)) which presents the results of studies to evaluate the ability of currently licensed seasonal influenza vaccine to confer cross-protection against highly pathogenic H5N1 influenza virus in mice. The article titled, Cross-Protection against H5N1 Influenza Virus Infection Is Afforded by Intranasal Inoculation with Seasonal Trivalent Inactivated Influenza Vaccine, concludes that "intranasal inoculation with annual influenza vaccine plus the Toll-like receptor-3 agonist, poly(I): poly(C12U)(Ampligen(r)), may overcome the problem of a limited supply of H5N1 virus vaccine by providing cross-protection mucosal immunity against H5N1 viruses with pandemic potential."
The JNIID study inoculated mice three times, either intranasally or subcutaneously, with the trivalent inactivated influenza vaccine licensed in Japan for the 2005-2006 season. The vaccine was administered together with Ampligen(r), an experimental therapeutic, as an immune enhancer. At 14 days after the final inoculation, the animals were challenged with one of three strains of H5N1 influenza virus. Compared with noninoculated mice, those inoculated intranasally manifested cross-reactivity of mucosal IgA and serum IgG with H5N1 virus, indicating cross-protection against varying strains of H5N1 influenza viruses.
Although currently not prominent in the Western headlines, the threat of an avian influenza pandemic still looms over the daily lives of most Asian populations. Endemic within the birds of the Asian region, H5N1 influenza virus continues to infect and kill human beings. According to World Health Organization statistics, as of October 12th, there have been 331 cases of avian influenza A/H5N1 reported and 202 deaths, a 61% rate of fatality.
Research efforts such as the JNIID's are focused on containing and eventually eliminating the pandemic threat that would arise if avian flu were to "cross over" and become capable of casual transmission among humans. As stated in the article's summary, "intranasal inoculation with both the trivalent inactivated influenza vaccine and Ampligen(r) induced cross-protection mucosal immunity to heterologous H5N1 influenza virus in mice. Intranasal inoculation with both the annual influenza vaccine and Ampligen(r) may thus represent a strategy that, in humans, can generate protective mucosal immunity against newly emerging and highly pathogenic avian influenza viruses."
As reported in earlier press releases, Hemispherx is currently conducting a clinical trial co-administering Ampligen(r), an experimental therapeutic, with seasonal influenza vaccine in Australia. The Company is also actively pursuing collaborations with vaccine manufacturers to replicate the Japanese studies in the U.S. and Europe.
On October 10, 2007 Hemispherx filed a New Drug Application (NDA) for Ampligen(r) as a primary therapy for Chronic Fatigue Syndrome (CFS). The Company plans additional filings with regulators in Europe in the coming months. The use of Ampligen(r) as an experimental immune enhancer with vaccines derives from the multiple actions of TLR3 activators such as Ampligen(r).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced biopharmaceutical 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(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(r) and Oragens(r). Ampligen(r) and Oragens(r) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 100 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates GMP certified manufacturing facilities 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. 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(r), Alferon LDO and Oragens) 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(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications.