PHILADELPHIA, June 3, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced that it has confirmed that one of its advanced stage biological products, Alferon® N, inhibits replication of the MERS virus in vitro. Chien-Te (Kent) Tseng, Ph.D., Associate Professor, Microbiology & Immunology at the University of Texas Medical Branch at Galveston, led the Alferon® N MERS-CoV experiments. Calu-3 cells were treated with Alferon® N 24 hours prior to infection with MERS-CoV. At 36 hours, supernatants were collected from cells and the virus titers were thereafter measured. Alferon® N showed significant dose-dependent inhibitory effects, thus suggesting the potential of Alferon® N as a preventative. Laboratory (in vitro) studies of potential antiviral agents are not necessarily predictive of clinical benefits. The Company supplied the Alferon N, but was not directly involved in the conduct of the experimentation. The results were forwarded to Hemispherx at the conclusion of the experiments for its review and formal publication is pending. The ability of Alferon N to inhibit replication of the MERS-CoV was also recently shown by experiments conducted at the National Institutes of Health (http://www.hemispherx.net/content/investor/default.asp?goto=781).
MERS-CoV is a recently emerged human coronavirus responsible for the lethal pulmonary syndrome known as MERS (Middle East Respiratory Syndrome). Globally, over 630 laboratory-confirmed cases of infection with MERS-CoV have officially been reported to WHO, including over 190 deaths. (http://www.who.int/csr/don/2014_05_23_mers/en/). Hemispherx plans to expand its MERS testing program.
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 The University of Texas Medical Branch at Galveston(UTMB)
Established in 1891 as the University of Texas Medical Department, UTMB has grown from one building, 23 students and 13 faculty members to a modern health science center with more than 70 major buildings, more than 2,500 students and more than 1,000 faculty.
The 84-acre campus includes four schools, three institutes for advanced study, a major medical library, a network of hospitals and clinics that provide a full range of primary and specialized medical care, an affiliated Shriners Burns Hospital, and numerous research facilities. UTMB is a component of the University of Texas System. Among the specialized research facilities at UTMB is the Galveston National Laboratory (GNL). As one of two National Biocontainment Laboratories constructed with funding from the National Institute of Allergy and Infectious Diseases/National Institutes of Health (NIAID/NIH), the GNL provides specialized biohazard research capabilities to develop therapies, vaccines, and diagnostic tests for naturally occurring emerging diseases such as SARS, West Nile encephalitis and avian influenza – as well as for microbes that might be employed by terrorists.
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 MERS-CoV. Moreover, it would take time, testing and funds to obtain approval of any such product.
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.