PHILADELPHIA, May 14, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced that it has entered into a formal collaborative research agreement to test Alferon N Injection®, the only multi-species, natural alpha interferon commercially approved in the U.S. 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® is a promising drug candidate."
About Alferon® N
Alferon® N is the only natural source, multi-species alpha interferon currently approved for sale in the U.S. Alferon® N is approved in the U.S. only for the treatment of refractory or recurring external genital warts caused by human papilloma virus ("HPV") in patients 18 years of age or older.
About SPIEZ LABORATORY
SPIEZ is the Swiss Federal Institute for NBC (Nuclear, Biological, Chemical) Protection and is the leading organization in Switzerland charged with the safety and security of the general population against biological, chemical and nuclear threats. SPIEZ Lab has fully equipped and staffed laboratories (about 100 people) for both in-vitro and in-vivo (small rodents) testing of products to prevent or treat potential NBC types of threats. Biological testing facilities and staff include BSL (Biological Safety Lab) level 3 and 4. SPIEZ LABORATORY develops and safeguards the necessary basic scientific and technological knowledge for comprehensive NBC protection. It also provides national and international organisations, the Swiss authorities, and general population with services to prevent, to prepare for and to manage disasters and emergencies. The work under the agreement will be guided by the head of virology, Dr. Marc Strasser.
About 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. Professor Richt is The Regents Distinguished Professor of Veterinary Medicine at Kansas State University, and an Eminent Scholar of the Kansas Bioscience Association (KBA).
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® (approved for refractory HPV infections) 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. Alferon® is considered an experimental product for the potential treatment of seasonal and pandemic influenza, and as such, may never be commercialized for these particular therapeutic uses.
Disclosure Notice
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. The final results of these efforts and/or any other activities could vary materially from Hemispherx's expectations.
Forward-Looking Statements
The foregoing release contains forward-looking statements that can be identified by words such as "will be, investigative, interim" or similar terms, or by express or implied discussions regarding potential efficacy for Hemispherx's Ampligen®, or regarding potential future revenues from Ampligen®. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of Management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Ampligen® will receive regulatory approval or be commercially successful in the future. In particular, management's expectations regarding Ampligen® could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the Company's ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors described in Hemispherx's filings with the Securities and Exchange Commission, including the most recent reports on Forms 10-K, 10-Q and 8-K on file with the U.S. Securities and Exchange Commission. Hemispherx is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.