PHILADELPHIA, June 4, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced today that a new peer reviewed publication titled "Development of mucosal adjuvants for intranasal vaccine for H5N1 influenza viruses" was published in Therapeutics and Clinical Risk Management 2009:5 125-132. The article summarizes ongoing research in which researchers conclude that Poly I:PolyC12U (Ampligen(r)), an experimental therapeutic, is the "most promising adjuvant candidate for mucosal vaccines." Poly I:PolyC12U (Ampligen(r)), an experimental therapeutic, was also "extremely important" in these studies, in that it produced cross-protection against variant influenza viruses not seen with the vaccines given alone.
Mucosal immunity has many potential advantages (please see Nature Medicine, supplement article titled "Mucosal Immunity and Vaccines" Vol. 11, number 4, pp. S45-S53). These advantages include a better stimulation of natural immunity than conventionally applied vaccines (intramuscular injection). Since most infections affect or start from a mucosal surface, topical application is often required to induce a protective immune response. However, in practice, it is often difficult to stimulate a strong SIgA immune response by mucosal administration of antigens given alone. Injectable vaccines can also give severe local reactions and the magnitude/ duration of protection may be less by parenteral (needle) delivery than by the topical application described by the JIID researchers.
The conclusion of the JIID researchers is that a pandemic of new influenza virus seems possible, and because it will be difficult to know when a pandemic will occur (or which strain of virus will be the cause), it is in the global community's best interest to develop broadly effective and safe vaccines against influenza virus. Hence, in the need for development of a broadly effective vaccine, induction of mucosal immunity is an inevitable requirement, as mucosal secretory IgA plays an important role in cross protection. Vaccines designed to induce mucosal immunity are necessary, in the JIID view, to combat a new influenza pandemic.
Today, Hemispherx Biopharma is summarizing its new influenza prevention/treatment data at a special Symposium on Pandemic Influenza in Rome under auspices of the Italian Government, which will include an update on the Japanese collaborations.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma 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. Ampligen(r) and Oragens 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 50 issued patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). 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. 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; similarly, the completion of the NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.