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Ampligen (R) Enhances the Effectiveness of Tamiflu Against Avian Influenza; Second Independent Preclinical Study Confirms dsRNA Increases Flu Vaccine Effectiveness.


PHILADELPHIA -- Hemispherx Biopharma, Inc. (AMEX AMEX

See: American Stock Exchange
: HEB HEB Hebrew
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HEB Hindu Endowments Board (Singapore)
HEB Here Everything's Better
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HEB High Energy Biscuit
) today reported two new preclinical studies on double-stranded 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
 (dsRNA), including Ampligen(R), one of its flagship experimental immunomodulators. Both preclinical studies suggest a new, and potentially pivotal, role of dsRNA therapeutics in improving the efficacy of the present standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given  in both influenza prevention and treatment of acute disease.

The first preclinical report, conducted by research affiliates of the National Institutes of Health at Utah State University Utah State University, mainly at Logan; coeducational; land-grant and state supported; chartered 1888, opened 1890. It publishes Utah Science, Western Historical Quarterly, and Western American Literary Journal. , compared the relative protection conveyed by Tamiflu (oseltamivir, Roche) and Ampligen(R) (dsRNA, Hemispherx), alone and in combination against the avian flu virus (H5N1). Cell destruction was measured in vitro using different drug combinations. Both drugs, given alone, were effective in inhibiting cell destruction by avian influenza, but viral "suppression with the combination was greater than either drug alone". The researchers reported, in summary; "The overall assessment is that there was improvement in cell protection when Ampligen(R) was combined with oseltamivir carboxylate carboxylate,
n a carboxylic acid salt, ester, or ion.
" (Tamiflu). Further immediate experimental tests are planned.

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

Double-stranded RNA (dsRNA), such as Ampligen(R), are also specific inducers of broad-spectrum antiviral/immune response. Recently, Japanese researchers (Journal of Virology The Journal of Virology is an academic journal that covers research concerning viruses, using cross-disciplinary approaches including biochemistry, biophysics, cell and molecular biology, genetics, immunology, morphology, physiology and pathogenesis.  page 2910, 2005) have also found that dsRNA's increase the effectiveness of influenza vaccine by more than 300% and may also convey "cross-protection ability against variant viruses" (mutated strains of influenza virus). Ampligen(R) recently completed Phase III testing in the chronic disease, Chronic Fatigue Syndrome chronic fatigue syndrome (CFS), collection of persistent, debilitating symptoms, the most notable of which is severe, lasting fatigue. In other countries it is known variously as myalgic encephalomyelitis, chronic fatigue and immune dysfunction syndrome, and  (CFS).

Hemispherx Biopharma recently disclosed in a letter to shareholders (September 1, 2005) that it has increased the capacity of its facility in New Brunswick, NJ to manufacture Ampligen(R) , as well as advancements in the application of Alferon LDO for potential treatment of avian flu.

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 immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon 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(TM) represent experimental nucleic acids being developed for globally important chronic viral diseases and disorders of the immune system including HPV HPV human papillomavirus.

HPV
abbr.
human papilloma virus


Human papilloma virus (HPV) 
, HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , CFS, 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 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) 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.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Sep 6, 2005
Words:639
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