Philadelphia, PA, Tuesday, January 07, 2014: Hemispherx Biopharma, Inc. (NYSE MKT: HEB) (the “Company” or “Hemispherx”) today announced publication of an article entitled “Emergence of a novel drug resistant H7N9 influenza virus: Evidence based clinical potential of a natural IFN-αlpha for infection control and treatment” in Expert Review of Anti-infective Therapy early online edition pages 1-5, 2014. H7N9 is a recently identified virus associated with high mortality in humans with the potential to emerge as an agent for a global pandemic. New cases of H7N9 have been very recently reported in China, Hong Kong and Taiwan. In vitro tests reported in the new article demonstrated that both oseltamivir (Tamiflu®) and Alferon N have significant inhibitory effect on a neuraminidase inhibitor sensitive H7N9 influenza virus. In contrast, Alferon N, but not Tamiflu®, had an inhibitory effect on the neuraminidase resistant Shanghai/1/H7N9 virus.
The research was conducted under the supervision of Juergen Richt, DVM, PhD, Director of the U.S. Department of Homeland Security Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), The Regents Distinguished Professor at Kansas State University, and an Eminent Scholar of Kansas Bioscience Association (KBA). Professor Richt is recognized as an expert on zoonotic agents and has published extensively on the monitoring of the mutations and the basic events leading to cross-species transmission and the opportunities to adapt to human hosts, with the potential to cause a pandemic.
According to the peer reviewed article “The novel avian H7N9 influenza virus has caused more than 130 human infections with 43 deaths (as of September, 2013) in China. Because of the lack of existing immunity against H7 subtype influenza viruses in the human population and the absence of a licensed commercial vaccine, antiviral drugs are critical tools for the treatment of infection with this novel H7N9. Both M2-ion channel blockers and neuraminidase inhibitors are used as antiviral drugs for influenza infections of humans. The emerging H7N9 viruses are resistant to the M2-ion channel blockers because of a S31N mutation in the M2 protein; additionally, some H7N9 isolates have gained neuraminidase R292K substitution resulting in broad resistance to neuraminidase inhibitors. In this study we report that Alferon N can inhibit wild type and 292K H7N9 viruses replication in vitro. Since Alferon N is approved for clinical use, this would allow a rapid regulatory approval process for this drug under pandemic threat.”
About the Center of Excellence for Emerging and Zoonotic Animal Diseases (CEEZAD), Kansas State University
CEEZAD, Center of Excellence for Emerging and Zoonotic Animal Diseases, was officially inaugurated in June 2010, with its first annual conference held in Manhattan, Kansas, home of Kansas State University. CEEZAD was formed to enhance the capability of the US Department of Homeland Security (DHS) by developing “state of the art” countermeasures for high priority emerging and zoonotic animal diseases.
The College of Veterinary Medicine at Kansas State University was established in 1905. Since then more than 5,000 men and women have been granted the Doctor of Veterinary Medicine degree. Departments within the College of Veterinary Medicine are anatomy and physiology, clinical sciences, diagnostic medicine/pathobiology.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx’s flagship products include Alferon N Injection® and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including Chronic Fatigue Syndrome. Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Because both Ampligen® and Alferon® LDO are experimental in nature, they are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®), approved for sale in the U.S. and Argentina. The Company’s Alferon N approval in Argentina includes the use of Alferon N Injection (under the brand name “Naturaferon”) for use in any patients who fail or become intolerant to recombinant interferon, including patients with chronic active hepatitis C infection. The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Competing Interests Disclosure
Dr. Richt is a compensated Scientific Adviser/Consultant for Hemispherx Biopharma, Inc., a public company, and is a shareholder in the company. In addition, Q Liu is a scientific adviser to Hemispherx; Dr. Strayer and Dr. Carter are management employees and shareholders of Hemispherx and Dr. WM Mitchell is in independent member of Hemispherx’ Board of Directors and a HEB shareholder. The foregoing related parties were authors of the mentioned publication.
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