ampligen
nom) "The Hemispherx double-stranded RNA drug product, trademarked Ampligen®, an experimental, unapproved drug, which is administered intravenously, is in human clinical development for various therapeutically oriented studies, including treatment for CFS/ME, HIV, renal cell carcinoma and malignant melanoma." 051102
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nom) 10/3/2005 8:56:00 AM EST

"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)..."
051102
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nom) "...the NIH supported independent study at the Utah State University has recently completed research that shows Ampligen(R), a Hemispherx experimental immunomodulator, demonstrates strong therapeutic synergy with Relenza(R) (Zanamivir).

In the study, researchers analyzed the effect of a combination of Ampligen(R) and Zanamivir on an influenza H5N1 infection in MDCK cells as determined by a cytopathic effect inhibition assay. Zanamivir had zero inhibitory activity when given alone (0.0032 microgram per milliliter) against the avian flu virus, however when co-administered with very low doses of Ampligen(R) (1 microgram per milliliter) it was shown to be 100% inhibitory.

With the threat of an avian influenza pandemic rising and health officials warning that the virus could develop resistance to current flu treatments, the pursuit of a cost-effective and capable adjuvant to existing antivirals and vaccines has become critical. This combination may permit the use of lower dosages and fewer injections of the antivirals and vaccines used to combat avian flu, thereby decreasing the cost of both immunization programs and treatment programs for the full-blown disease..."
051103
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. (11/3/2005 8:30:00 AM EST) 051103
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