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Hemispherx Biopharma Signs Research Agreement With Japanese National Institute of Infectious Disease; Ampligen(R) Sought As Adjuvant for Nasal Flu Vaccine

Posted on: Monday, 3 October 2005, 09:00 CDT

Hemispherx Biopharma, Inc (AMEX: HEB) has signed a research agreement with the National Institute of Infectious Diseases, in Tokyo, Japan. The collaboration, by Hideki Hasegawa, M.D., Ph.D., Chief of the Laboratory of Infectious Disease Pathology, will assess Hemispherx' experimental therapeutic Ampligen(R) as an adjuvant to the Institution's nasal flu vaccine.

In a recent published study in the Journal of Virology (March 2005, p. 2910-2919), Dr. Hasegawa and colleagues found that double-stranded RNA (dsRNA), such as Ampligen(R), increases the effectiveness of the influenza vaccine by more than 300% and Ampligen(R) may also convey cross-protection ability against variant viruses (mutated strains of influenza virus).

New data from preclinical studies on dsRNA, including Ampligen(R) supports the role of dsRNA therapeutics in improving the efficacy of the present standards of care in both influenza prevention and treatment of acute disease.

A recent preclinical report, conducted by research affiliates of the National Institutes of Health at Utah State University, compared the relative protection conveyed by Tamiflu (oseltamivir, Roche) and the Company's experimental therapeutic Ampligen(R), alone and in combination against the avian flu virus (H5N1). Ampligen was among more than 10 different drug combinations examined in the studies aimed to seek therapeutic synergy with the vaccines.

In antimicrobial (antibacterial) therapy, which is the best studied clinical model, synergistic drug combinations may result in curative conditions/outcomes, often not observed when the single drugs are given alone. In the case of avian influenza where global drug supplies are presumptively in very limited supply relative to potential needs, therapeutic synergistic combinations could not only affect the disease outcome, but also the number of individuals able to access therapies.

By providing a new mechanism of inhibition of avian flu, (i.e. immunologic/host defensive immune cascades), Ampligen(R), an experimental therapeutic, may also afford a new time interval to help combat the influenza virus. At present, a narrow window of opportunity (approximately 48 hours) exists for effective utilization of Tamilflu after exposure to influenza.

Hemispherx recently completed Phase III testing of Ampligen(R) for Chronic Fatigue Syndrome (CFS).

About Hemispherx Biopharma

Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Hemispherx's flagship products include Alferon and the experimental therapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon is approved for a category of STD infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important chronic viral diseases and disorders of the immune system including HPV, HIV, CFS and Hepatitis. Hemispherx's platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) 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) and Oragens(TM)) 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(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications.

Source: Business Wire

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