PHILADELPHIA, June 16, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) announced that a new publication (June 2, 2014) in the Formulary Journal (http://formularyjournal.modernmedicine.com/formulary-journal/news/mers-interferoninnate-immune-deficiency-state-continues-surge?page=full ) suggests that the high pathogenicity of MERS may be due, in part, to an innate immune deficiency state that results secondary to inhibition of a first responder to viral infection, interferon (IFN), at an early step in MERS infection. The article, "MERS, an interferon innate immunity state, continues to surge" is authored by Hemispherx scientists and affiliates. The authors suggest that correcting the defect in immunity may be the first significant way to decrease MERS-associated mortality.
More recently, there has been a dramatic, non-Ramadan associated, increase in new cases of MERS. Ramadan will begin on June 29th, 2014, and 19 countries have now identified MERS cases.
MERS-CoV and SARS-CoV (Severe Acute Respiratory Syndrome) viruses are members of the same virus family-termed coronavirus. Only MERS and SARS have high mortality rates in man as the other four human coronavirus family members are generally associated with mild, non-life-threatening, common cold symptoms. Only the MERS virus and SARS inhibit the production of a key component of human immunity, IFN. IFN has been previously established as necessary to fight off a number of otherwise lethal viral infections.
Recent Hemispherx collaborations with the National Institutes of Health (NIH), specifically National Institutes of Allergy and Infectious Disease (NIAID), using human cells in culture suggest that Alferon® N may be effective either as a preventative or treatment of early MERS infection (http://www.hemispherx.net/content/investor/default.asp?goto=781). Subsequently, similar positive inhibitory results with Alferon® N were obtained at the University of Texas (http://www.hemispherx.net/content/investor/default.asp?goto=786).
Treatment late in the course of human highly lethal coronaviral infections (MERS/SARS) is unlikely to alter the diseases course as, by then, the host immune system has already been severely disabled. Going forward, clinical protocols will need to be established to evaluate various systemically therapeutic options rather than by isolated treatments of certain infected individuals as are currently employed.
MERS-CoV is a recently emerged human coronavirus responsible for the lethal pulmonary syndrome known as MERS. Globally, over 800 cases of infection with MERS-CoV have been reported, including at least 310 deaths. (http://www.cidrap.umn.edu/news-perspective/2014/06/news-scan-jun-09-2014) (http://www.nydailynews.com/life-style/health/hospital-breaches-worsened-mers-outbreak-uae-article-1.1822529). Hemispherx plans to expand its MERS experimental testing program as quickly as possible, including animal and in vitro experiments testing Alferon N and Ampligen against the MERS virus.
"First reported in humans in 2012, MERS causes severe and often fatal respiratory illness, with symptoms similar to those seen during the outbreak of severe acute respiratory syndrome (SARS) in 2003. Its around 40 percent death rate and reports of clusters of human-to-human transmission have raised concerns it may blow up into a pandemic." (http://www.nydailynews.com/life-style/health/hospital-breaches-worsened-mers-outbreak-uae-article-1.1822529)
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 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 or any other human coronavirus infection. 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.