Hemispherx Biopharma has entered into a formal collaborative research agreement to test Alferon N Injection, the only multi-species, natural alpha interferon commercially approved in the US.
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It will now be evaluated against wild type and Tamiflu (oseltamivir)-resistant H7N9 influenza virus under the DEA (Data Exchange Agreement) Annex for Medical Preparedness and Bio-Defense Agreement between the Swiss Surgeon General and the US Department of Defense.
The increasing prevalence of Tamiflu-resistant Influenza A Virus, particularly against H7N9, has been widely reported and is due in large part to the fact that just a single-step mutation in this genetically unstable virus can make it resistant to Tamiflu.
This collaboration is intended to extend the results announced at the 53rd annual meeting of Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado September 13-15, 2013.
These experiments were conducted by Professor Juergen Richt, DVM, Ph.D., Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD) and demonstrated that Alferon N is a potent inhibitor of both wild-type influenza virus H7N9 as well as Tamiflu-resistant influenza strains.
According to a new study by the non-profit Cochrane Collaboration, global network of health care academics, Tamiflu is not proven to reduce flu complications, like pneumonia and hospital stays, raising questions about Tamiflu use against pandemics.
As published in the British Medical Journal (BMJ 2014;348:g2545/Ibid g2547), examination of earlier clinical studies found prophylactic reduction in symptoms of only 55% and no indication that Tamiflu is effective in reducing complications, key components in reducing the morbidity and rate of pandemic spread of influenza. The studies also question the risk/benefit ratio provided by Tamiflu.
The Cochrane reviewers examined all 107 existing clinical reports on Tamiflu and another less widely used flu drug (Relenza (zanamivir)). Evidence from the trials reviewed showed Tamiflu and Relenza alleviated flu-like symptoms in adults about half a day faster than in those taking a placebo. The Cochrane reviewers and the BMJ have also called on governments and health policy decision makers throughout the world to review their guidance on the use of Tamiflu in light of the recent findings.
Col. Dr. Sergei Bankoul, M.D., Swiss Armed Forces Logistics, Medical Services Directorate, Head of Medical CBRN Defense of the Armed Forces and Senior Consultant to the Swiss Surgeon General, Major General Andreas Stettbacher, said, "We need an effective, convenient-to-use, and widely administrable preventative and therapeutic for pandemic influenza outbreak to accompany the commitment the Swiss Military has made to a rapid, point-of-care diagnostic test for H7N9 to provide a ‘1:2 punch’ to a pandemic threat or outbreak and under our Agreement with the US Department of Defense. Based on research to date, Alferon(R) is a promising drug candidate."