Hemispherx Avian Flu Prevention/Treatment Program Announces New Primate Results and Expands in both Europe and Southern Hemisphere
In the primate study, macaque 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 greater than 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 licensed therapeutic for another 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 "TLR3 agonist" (stimulator) may be sufficient.
The U.S. Department of Health and Human Services (HHS) 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 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 infection, and Ampligen(R) and Oragens(R) represent experimental RNA 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 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.
Hemispherx Biopharma, Inc.
Dianne Will, 518-398-6222
CCG Investor Relations
Sean Collins, Sr. Partner, 310-477-9800
Posted: February 2007