Japanese Ministry Awards Grant to Advance Studies with Influenza Vaccines Co-Administered with Hemispherx's Ampligen(R).
PHILADELPHIA -- Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that Japan's Ministry of Health, Labor and Welfare (MHLW) issued authorization to its National Institute of Infectious Diseases (NIID) approving their budget to advance studies indicating that an H5N1 influenza vaccine co-administered intranasally with Hemispherx's experimental therapeutic double stranded RNA (dsRNA) Ampligen[R] (Poly I; Poly C12U) protected against mutated strains of the virus and, further that, the seasonal trivalent influenza vaccine co-administered intranasally with Ampligen[R] maintained efficacy even when challenged with the H5N1 influenza virus.
The studies are to be lead by Dr. Hideki Hasegawa of the National Institute of Infectious Diseases with whom Hemispherx has been collaborating on the earlier animal studies. Enlarged studies, scheduled over three years, will focus initially on efficacy and stability as it pertains to the formulation of the vaccine and adjuvant (Ampligen[R]). Subsequent studies will focus on GLP (Good Laboratory Practices) studies required for regulatory submission including pharmacology, safety, toxicology, reproduction and carcinogenicity, followed by clinical studies.
Dr. Hasegawa initially presented the results of his studies at the Second International Conference on Influenza Vaccines for the World in Vienna, Austria in October 2006. In this presentation, he examined the protective efficacy of intranasal co-administration of inactivated whole-virion H5N1 vaccine with Ampligen[R] in mice and non-human primates. Intranasal administration of a candidate influenza vaccine with Ampligen[R] resulted in dramatically increased secretion of IgA (also known as immunoglobulin A) which formed the basis of mucosal immunity. The induced mucosal immunity thereafter protected subjects when challenged with Vietnam, Hong Kong and Indonesian strains of the H5N1 viruses.
Dr. Hasegawa's presentation concluded: 1) that the intranasal administration of Ampligen[R] combined with H5N1 vaccine induced cross-protective mucosal immunity against heterologous H5N1 influenza virus infection in mice; 2) intranasal administration of Ampligen[R] combined with H5N1 vaccine provided protection in the macaque monkey, a non-human primate which has a complex immune system ,similar to that of humans, from H5N1 infection; and 3) Ampligen[R] is the only human-applicable dsRNA which has a well-documented safety profile in humans.
Dr. Hasegawa conveyed his desire to commence the studies as soon as possible.
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.
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|Date:||Apr 12, 2007|
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