PHILADELPHIA, Sept. 22, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx"), announced today a peer-reviewed publication entitled "Protection from Pulmonary Tissue Damage Associated with Infection of Cynomolgus Macaques by Highly Pathogenic Avian Influenza Virus (H5N1) by Low Dose Natural Human IFN-α Administered to the Buccal Mucosa" in the current issue of Antiviral Research 2014. This publication is a collaborative project conducted at Viroclinics Biosciences BV, Rotterdam, an internationally recognized research facility for the study of influenza viruses. The biohazard laboratories are directed by Prof. Albert D. M. E. Osterhaus, an internationally known virologist specializing in the study of pandemic influenza. Highly pathogenic avian influenza A (H5N1) virus is endemic in wild birds in Asia and the Middle East, causing disease and transmissibility in domestic poultry. Infection of humans with H5N1 is associated with a high mortality rate (~60%) due to an alveolar destructive primary viral pneumonia frequently expressed clinically as acute respiratory distress syndrome (ARDS) (Abdel-Ghafar et al. NEJM 2008;358:261-273).
On September 8, 2014, the World Health Organization (WHO) said that the Southern Hemisphere's flu season is still underway in many countries, notable in Australia, where some flu markers are at a 5-year high. In Northern Hemisphere countries, flu remained at interseasonal levels.
Based on a report of efficacy following oral administration of Alferon® N (Cummins et al. AJVR 2005;66:164-176), a study was initiated to determine whether an experimental low dose oral formulation (Alferon® LDO) of the natural IFN-α (Alferon N Injection®) could blunt the pathogenesis of a highly pathogenic influenza virus, H5N1. Using an established non-human primate model for H5N1 infection (Kuiken T, et al. Vet Pathol 2003;40:304-310), the collaborative team evaluated the potential for the prophylactic treatment of the pulmonary damage characteristic of fatal cases from primary influenza virus pneumonia using Alferon® LDO.
The study, funded by Hemispherx, demonstrates a dose-dependent prophylactic mitigation of the pulmonary damage characteristic of human fatal cases from primary influenza virus pneumonia with Alferon® LDO. At the highest oral dose (62.5 IU/kg body weight) used, there was a marked reduction in the alveolar inflammatory response in contrast to the hemorrhage and inflammatory response observed in the untreated control animals. The mitigation of severe damage to the lower pulmonary airway was observed without a parallel reduction in viral titers. Clinical trial data will be necessary to establish the prophylactic human efficacy of Alferon® LDO for highly pathogenic influenza viruses.
Alferon® N is the only natural alfa-interferon (IFN) which has received a full FDA approval for commercial sales. Alferon® N is approved under a biological product license for manufacture in Hemispherx's New Brunswick, NJ facility for treatment of refractory or recurring general warts in adults. Alferon® LDO is an experimental oral formulation of Alferon® N that has been used in limited clinical trials to date in various viral conditions including HIV/AIDS.
About Viroclinics Biosciences BV
Viroclinics Biosciences BV is a leading diagnostic and clinical trial operation service company providing diagnostic and preclinical studies along with drug development for prevention and treatment of virus infections. Viroclinics Biosciences BV's mission is to improve human and animal health by serving the biopharmaceutical industry with state-of-the-art diagnostics, operational and logistical services, custom-made models in preclinical and clinical drug testing, and expert advice on development of antivirals and vaccines. Viroclinics Biosciences BV offers a full range of virology services for new drug development programs and post-marketing surveillance of existing drugs and vaccines, ranging from traditional virology assays to the latest deep sequencing protocols for a very broad range of viruses.
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 certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net
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. Animal experiments are not necessarily predictive of clinical outcome and no representations are made that any products described in this release will be ultimately determined safe and effective in the prevention and/or treatment of any form of Influenza. Moreover, it would take time, testing and funds to obtain approval of any such product and there are no assurances that a commercial approval for treatment of Influenza can be obtained.
Forward-Looking Statements
To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "potential," "potentially," "possible," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Hemispherx that any of its plans will be achieved. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond Hemispherx's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. Examples of such risks and uncertainties include those set forth in the Disclosure Notice, above, as well as the risks 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. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Hemispherx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise revise or update this release to reflect events or circumstances after the date hereof.