Hemispherx Avian Flu Prevention/Treatment Program Announces New Primate Results and Expands in both Europe and Southern Hemisphere.Experimental Treatment Designed to Prevent/Treat Multiple H5N1 Classes with Oral Non-Toxic Treatment PHILADELPHIA -- Hemispherx Biopharma, Inc. (AMEX AMEX See: American Stock Exchange :HEB HEB Hebrew HEB Hurst-Euless-Bedford (Texas) HEB Hot Electron Bolometer HEB Hindu Endowments Board (Singapore) HEB Here Everything's Better HEB High-Energy Beam HEB High Energy Biscuit ) announced today initial results of a new primate treatment program with Viroclinics, based in the Netherlands, and directed by Professor Albert Osterhaus, a world authority in Avian influenza spread and prevention. In the primate study, macaque macaque (məkäk`), name for Old World monkeys of the genus Macaca, related to mangabeys, mandrills, and baboons. All but one of the 19 species are found in Asia from Afghanistan to Japan, the Philippines, and Borneo. monkeys were pre-treated orally (sublingually) with either Alferon-N (a proprietary formulation of 8 molecular types of human alpha interferon) or placebo. Thereafter, they were exposed to highly pathogenic avian influenza virus, strain H5N1, which has resulted to date in a > 60% death rate in humans. Control animals, as expected, shown massive pneumonia by both gross and microscopic examination which was greatly ameliorated by treatment with Alferon LDO (applied sublingually). The Hemispherx Vaccine Enhancement[TM] Platform is the utilization of Alferon LDO (derived from an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. licensed therapeutic for another virus, HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) ) via the Viroclinics collaboration based on promising results in a human volunteer study recently conducted in Hong Kong. Based on earlier primate studies reported by the independent Japanese Institute of Infectious Diseases (JIID), collaborating with Hemispherx, the addition of Hemispherx's second experimental therapeutic, Ampligen[R], may also provide vaccine cross-protection against different H5N1 strains when co-administered with a influenza vaccine. In the expanded Australian clinical trial, studies will determine whether seasonal vaccine co-administered with the experimental therapeutic Ampligen[R], may provide long-lasting seroprotection against either/both of the emerging strains of H5N1. The level of measured immune response to provide adequate protection in humans is as yet unknown, however, primate and lower animal research conducted by the JIID suggest that broad based cross protection in man by a single therapeutic treatment (Ampligen[R]), acting as a "TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) 3 agonist" (stimulator) may be sufficient. The U.S. Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Health and Human Services, HHS (HHS HHS Department of Health and Human Services. ) has recently announced a new pre-pandemic vaccine procurement program out of concern that the existing vaccine "won't work well" against the newer pandemic strains now spreading thru birds in China, Indonesia (2004), the Middle East, Europe and Africa (2006) and Great Britain (2007). Based on these overall positive results, the Company has initiated active discussions with the U.S. Department of Defense regarding its biopreparedness, biodefense initiatives and priorities. About Hemispherx Biopharma Hemispherx Biopharma, Inc. is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction disorders. Hemispherx's flagship products include Alferon N Injection[R] and the experimental therapeutics Ampligen[R] and Oragens[R]. Alferon N Injection[R] is approved for a category of STD (Subscriber Trunk Dialing) Long distance dialing outside of the U.S. that does not require operator intervention. STD prefix codes are required and billing is based on call units, which are a fixed amount of money in the currency of that country. infection, and Ampligen[R] and Oragens[R] represent experimental RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic nucleic acids being developed for globally important viral 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, a fully commercialized product (Alferon N Injection[R]) and GMP GMP (guanosine monophosphate): see guanine. certified manufacturing facilities for its novel pharma 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. |
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