Hemispherx forms flu research agreement with Defense R&D Canada

By Angela McDaniels

Seattle, Nov. 29 - Hemispherx Biopharma Inc. said it has entered into an agreement with Defense R&D Canada-Suffield to evaluate the antiviral efficacy of its experimental therapeutic agents Ampligen and Alferon for protection against human respiratory influenza virus infection in a mouse-adapted strain of human influenza.

The agency has already conducted extensive research in the use of liposome delivery technology to enhance the antiviral activity of a closely allied Ampligen analogue, Poly ICLC.

Results suggest that ribonucleic acid-based drugs have the ability to elicit protective broad-spectrum antiviral immunity against various pathogenic viruses, the company said. Hence, there is the potential for efficacy to be maintained against mutating strains of an influenza virus.

Liposomes, a carrier system for nucleic acid-based drugs, have shown an ability to protect these drugs against in vivo degradation, delivering them to intracellular sites of infection, thereby reducing any toxicity and prolonging their therapeutic effectiveness.

Protection can be afforded for 21 days with two doses of dsRNA. Tamiflu, given twice daily, may ameliorate flu symptoms, the company said.

"Previous studies have shown that there are certain limitations using Poly ICLC as an antiviral drug due to its inherent toxicity even though it has pronounced therapeutic activity. In contrast, Ampligen and Alferon have encouraging safety profiles to date and Ampligen shares similar structure with Poly ICLC. The experimental combination has the potential to be a very promising therapy," said William Carter, Hemispherx chief executive officer, in a company news release.

Hemispherx is also engaged in ongoing experimental studies assessing the efficacy of their products Ampligen, Alferon N Injection and Alferon LDO (Low Dose Oral) as an adjuvant or single agent antiviral with the National Institute of Infectious Diseases in Tokyo, the Princess Margaret Hospital in Hong Kong and various research affiliates of the National Institutes of Health in the United States.

Alferon N is commercially approved for chronic refractory Human Papillomavirus, and Ampligen has recently completed phase 3 clinical testing in another viral-associated disorder in the United States, the company said.

Ottawa-based Defense R&D Canada is an agency of the Department of National Defense responding to the scientific and technological needs of the Canadian Forces, including research and development of avian flu drugs.

Hemispherx, 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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