PHILADELPHIA, Sept. 10, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE:HEB) (the "Company" or "Hemispherx"), announced that it expanded its Collaborative Research Agreement to test Alferon®, the only multi-species, natural alpha interferon (IFN) commercially approved in the U.S. and Ampligen®, an experimental drug, to be evaluated against the deadly Ebola virus also 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 World Health Organization (WHO) has warned that "The Ebola outbreak will affect more than 20,000 people in West Africa and might spread to more countries, indicating a clinical emergency all over the world."
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, "The Ebola outbreak has killed more than 1,000 people and we are very concerned about its further spread. As the WHO has said, the flood of patients indicates the outbreak could be far more severe than numbers show. Given the scientific basis of Ebola's lethality and the potential ability of Alferon and Ampligen to both possibly replenish and restore an Ebola patient's interferon capability, we are eager to commence testing of these two products." Col. Bankoul went on to say that "The Spiez Lab's also intends to use its new and extensive capabilities to evaluate the possibly broad therapeutic potential of Alferon and Ampligen against a wide range of deadly viruses."
Early events in Ebola virus infection influence the patient's ability to develop an effective immune response. The success of Ebola virus replication is dependent on viral inhibition of initial innate immune responses to infection. Disarming innate immune responses is a common mechanism employed by highly pathogenic human viruses that include the influenza and corona viral families. Ebola counteracts the host innate immune response by blocking the cellular production of Type I IFN.
A key component of innate immune responses is activation of the Toll-like receptors (TLRs). TLR3 activation by dsRNA is an essential response element to viral infection. Block TLR3 activation and an essential element of the innate immune response is disarmed. Ampligen, Poly I:Poly C12U (rintatolimod) was designed as an IFN inducer and has demonstrated antiviral activity in a wide variety of DNA and RNA viruses in pre-clinical testing. By replenishing an Ebola patient's natural interferon with Alferon and restoring that patient's innate immune response by Ampligen's overcoming the Ebola blocking mechanisms, Ebola virus replication could be potentially significantly reduced.
Tom Equels, Executive Vice Chairman of Hemispherx, said, "We are excited to offer Alferon N and Ampligen as a potential therapeutic for the treatment of Ebola and other lethal viruses for which there is an unmet medical need. Should these important experiments being conducted at Spiez Lab render positive results, Hemispherx has the potential to provide large quantities of these products from its GMP facility in New Brunswick, New Jersey. Given that other potential treatments cannot be supplied in quantity, Hemispherx hopes to be a major contributor to minimizing the effects of this outbreak."
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 in patients 18 years of age or older.
About Ampligen®
Ampligen®, an experimental therapeutic, is a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation.
About Spiez Laboratory
Spiez Laboratory 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, being set up) 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 organizations, the Swiss authorities, and general population with services to prevent, to prepare for and to manage disasters and emergencies.
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
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. In vitro 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 the Ebola virus. 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 the Ebola virus 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.