FDA authorizes expansion of clinical trial on flu therapeutic

Hemispherx Biopharma, Inc., a Philadelphia-based specialty pharmaceutical company, announced on Monday that the U.S. Food and Drug Administration expanded a clinical trial for Ampligen, an experimental flu therapeutic.

The Phase I/II clinical trial at the University of Alabama Vaccine Research Clinic is being expanded based on an analysis of safety results to date conducted by a data monitoring committee and the FDA. The study is the first extension to humans of preclinical studies indicating that the combination of Ampligen with commercially available seasonal flu vaccine, when applied intranasally, may enhance protection against potentially pandemic flu strains.

Ampligen is an experimental RNA nucleic acid being developed for debilitating immune system disorders, such as chronic fatigue syndrome. In preclinical studies with Ampligen, a broad range of potentially protective immune molecules were identified in the blood stream and nasal washings.

Paul Goepfert, an associate professor of medicine at the Alabama Vaccine Research Clinic, said flu is typically transmitted through the nasal passage. He said that in animal studies, Ampligen provided cross-protection to flu virus strains that were not expected to be conveyed by the administered vaccine.

A pandemic flu outbreak could kill millions of people without an available therapeutic. The Spanish flu pandemic killed between 20 million and 100 million people in 1918-1919. A 2004 estimate found that a similar epidemic would kill approximately 60 million people in the present, according to research published in Lancet.