PHILADELPHIA, July 22, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced that a new publication abstract in Infectious Disorder Drug Targets (2014 Jul 13. [Epub ahead of print]) is available for review as described in PubMed on July 16, 2014, and proposes that the Middle East Respiratory Syndrome (MERS)/(Severe Acute Respiratory Syndrome) SARS coronaviruses (CoV) may be most effectively inhibited by interferons (IFNs) and an IFN inducer (http://www.ncbi.nlm.nih.gov/pubmed/?term=Sensitivity+of+SARS%2FMERS+CoV+to+Interferons+and+Other+Drugs+Based+on+Achievable+Serum+Concentrations+in+Humans). The article, entitled "Sensitivity of SARS/MERS CoV to Interferons and Other Drugs Based on Achievable Serum Concentrations in Humans", is authored by Hemispherx scientists. It is suggested that correcting a viral induced defect in immunity may be the first significant way to decrease MERS/SARS associated mortality.
Recently, there has been a dramatic, non-Ramadan associated, increase in new cases of MERS. Ramadan began on June 29, 2014. The World Health Organization (WHO) has been informed of a total of 834 laboratory confirmed cases of infection with MERS-CoV globally, including 288 deaths (http://www.who.int/csr/don/2014_07_14_mers/en/).
The Hajj pilgrimage, which is a duty of Muslims to perform once in their lives, usually brings even larger crowds than Ramadan. Hajj, which starts in October this year, brings about 2 million pilgrims together in close quarters as they visit Islam's holiest site, and other locations in Mecca.
A recent study in Lancet Infectious Diseases modeled how the MERS-CoV virus could spread during air travel and found a risk of spread from those infected during flight. The risk ranged from 1 to 15 new infections from a MERS "superspreader" based on a 5 to 13 hours of travel and relative location within the plane (First Class and Economy Class sections of a plane being compared). A recent Eurosurveillance article also notes how central the Middle East has become for global travel.
On July 3, 2013, the Centers for Disease Control (CDC) updated its own guidance on air transport of MERS patients, recommending only specially equipped aircraft, not commercial passenger planes (http://www.cdc.gov/coronavirus/MERS/hcp/air-transport.html).
The CDC now further recommends eye protection to prevent droplet exposure plus respiratory protection with at least 95% filtering efficacy (e.g., an N-95 respirator or higher). In addition, the CDC recommends that, whenever possible, MERS patients be moved on a dedicated flight with a minimum number of crew members and no other non-MERS passengers. The Director of the CDC, Dr. Friedman, will address concerns about MERS and other key health issues at the National Press Club on July 22, 2014.
MERS-CoV and SARS-CoV are members of the same coronavirus family. 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 and SARS viruses 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).
The comparison of drug sensitivity (to be provided with publication of the full length paper in Infectious Disorder Drug Targets) is based on clinically achievable serum concentrations for each drug evaluated in human cell culture or the tolerable human dosage levels per kilogram for drugs tested in animal studies. Those calculations are then used to predict/extrapolate the most active drugs against SARS/MERS. This calculation ranked certain alpha and beta IFNs and a TLR agonist as the most promising experimental therapeutics.
Hemispherx Biopharma continues to be in active dialogue with various agencies responsible for various aspects of biosecurity designed to protect U.S. citizenry. No representation can be made that these discussions will lead to clinical collaboration and/or contractual relationships.
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 systemically various therapeutic options rather than by isolated treatments of certain infected individuals as are currently employed.
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.
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 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.
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.
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.
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