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Ampligen/Roche Avian flu studies extended

Hemispherx Biopharma has extended a preclinical report conducted by research affiliates of the US 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 Roche’s Tamiflu (oseltamivir) and Hemispherx’s Ampligen (dsRNA), 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. 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.

In the case of avian influenza, where global drug supplies are presumptively in 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.

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.