Ampligen(R) Studies on Combinational Treatments Against Avian Influenza are Extended
Wednesday October 26, 10:22 am ET
Tamiflu Resistant Strains are Reported in Asia
PHILADELPHIA--(BUSINESS WIRE)--Oct. 26, 2005--Hemispherx Biopharma, Inc. (AMEX: HEB - News) has extended a preclinical report conducted by research affiliates of the National Institutes of Health at Utah State University to examine potential therapeutic synergies with more than 10 different drug combinations. The ongoing research is comparing the relative protection conveyed by Tamiflu (oseltamivir, Roche) and Ampligen® (dsRNA, Hemispherx), alone and in combination, against the avian flu virus (H5N1).
True therapeutic synergy is defined by mathematical equations which indicate that the therapeutic effect observed is in fact greater than the expected arithmetic sum of the two drugs working independently, and is referred to by pharmacologists as the "Chou/Talalay" equations developed at Johns Hopkins University. True therapeutic synergy has now been observed in the interaction between Ampligen® and Tamiflu in the inhibition of the Avian influenza virus.
Hemispherx recently reported new data on preclinical studies on double-stranded RNA (dsRNA), including Ampligen®, one of its flagship experimental immunomodulators. These studies suggest a new, and potentially pivotal, role of dsRNA therapeutics in improving the efficacy of the present standards of care in both influenza prevention and treatment of acute disease.
The studies are attracting growing attention with the persistence of H5N1 avian influenza viruses in many Asian countries and their ability to cause fatal infections in humans. Concerns throughout the Region have risen with the discovery of a Tamiflu resistant strain of the virus. NATURE (14 October 2005), a respected science journal, reported that on February 27, 2005 an H5N1 influenza virus, A/Hanoi/30408/2005, was isolated from a 14 year old Vietnamese girl (patient 1) who had received a prophylactic dose of Tamiflu (oseltamivir). Although further investigation is needed, analysis of the isolated virus revealed two disturbing possibilities; that the virus could have been transmitted to the girl from her brother and that the virus was developing a resistance to Tamiflu. Although the findings were based on a single patient, the authors, in their conclusion, recommend the stockpiling of alternatives to Tamiflu. Hemispherx's Ampligen® is emerging as one of the more promising experimental alternatives.
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. Cell destruction was measured in vitro using different drug combinations.
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®, an experimental immunotherapeutic, may also afford a new time interval to help combat the influenza virus.
Recently, double-stranded RNA (dsRNA), such as Ampligen®, are also specific inducers of broad-spectrum antiviral/immune response. As noted in the Company's announcement of September 6, 2005, Japanese researchers have also found that dsRNAs 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).
Hemispherx Biopharma recently disclosed they entered into a collaboration with HollisterStier Laboratories of Spokane, Washington, for the contract manufacturing of Hemispherx's experimental drug, Ampligen®. The achievement of the initial objectives, in combination with the Polymer production facility under construction in New Brunswick, N.J., will enable Hemispherx to significantly increase production capacity.
Ampligen® also recently completed Phase III testing in the chronic disease, 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 immunotherapeutics/antivirals Ampligen® and Oragens(TM). Alferon is approved for a category of STD infection, and Ampligen® 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, 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® 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® do not imply that the product will ever be specifically approved commercially for these other treatment indications.
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