Hemispherx Biopharma's Ampligen and Alferon LDO may provide defense against avian flu

By Elaine Rigoli

Tampa, Fla., Feb. 16 - Hemispherx Biopharma, Inc. unveiled the results of laboratory testing that shows its two investigational immunotherapeutics, Ampligen and Alferon, are potentially useful against the H5N1, or avian flu, virus.

The pre-clinical research indicates that Ampligen, a specifically configured double-stranded RNA, can provide cross-protection against avian flu viral mutations as well as boost the effectiveness of Tamiflu and Relenza, the only two drugs formally recognized for fighting the bird flu, up to 100 times.

Other lab tests, in healthy human volunteers, indicate that Alferon LDO (low-dose oral), a new delivery form of an anti-viral with prior regulatory approval for a category of sexually transmitted diseases, can stimulate genes that induce the production of interferon and other immune compounds, key building blocks in the body's defense system.

Results of a study show that animals that were internasally administered with the vaccine Ampligen registered an increase in antibodies that could fight the deadly virus. Some 80% of the Ampligen-treated mice survived the virus's onslaught, while none survived in a corresponding placebo group.

Independent lab research conducted at Utah State University under the National Institutes of Health sponsorship indicates that Ampligen increases the efficacy of the two viral uptake inhibitors, Tamiflu and Relenza. The lab studies suggest that 50 to 100 times less Tamiflu may be used in conjunction with the experimental immunotherapeutic Ampligen to achieve full inhibition with no multiplication of the virus, and no host cell damage, according to a release.

This may be a critical factor not only because of the potential shortage of Tamiflu, but also because 18% of all children are resistant to Tamiflu at conventional doses (as reported in the New England Journal of Medicine, December 2005), the release stated.

Results from phase 1/phase 2 clinical trials in healthy volunteers being conducted at the Princess Margaret Hospital in Hong Kong indicate that Alferon LDO may strengthen human immune responses via interferon-activated genes, potentially staving off infection should an individual be exposed to the virus. By priming the body's own interferon pump, Alferon LDO might enable an infected host to produce enough interferon to overcome the virus.

"Given the potential for a pandemic, these results may have significant implications for control of the avian flu virus," said Hemispherx chairman and chief executive William A. Carter, MD, in a company statement.

"In relevant animal models and human volunteer studies, both experimental immunotherapeutics, Ampligen and Alferon LDO may trigger the production of novel defense products as part of the body's immune system. Therefore, we are encouraged that these experimental immunotherapeutics represent a significant new path forward in potential preparation against the global spread," he added.

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.

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