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Hemispherx Biopharma (HEB)'s Two Drugs, Ampligen® And Alferon® Ranked Highly In Sensitivity Testing Against MERS/SARS Coronaviruses



8/4/2014 8:24:03 AM

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PHILADELPHIA, Aug. 4, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) announced today a peer-reviewed electronic publication entitled "Sensitivity of SARS/MERS CoV to Interferons and Other Drugs Based on Achievable Serum Concentrations in Humans" in the current issue of Infectious Disorders – Drug Targets, vol. 14, 2014. The authors of the publication include D.R. Strayer and W.A. Carter, who are affiliated with Hemispherx.

In 2003, Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV) sickened nearly 8,000 people and killed 774 world-wide after spreading to 30 countries. In 2012, a new CoV, Middle East Respiratory Syndrome (MERS) CoV first appeared in Saudi Arabia and has now been reported in approximately 20 countries including the United States. The World Health Organization (WHO) has been informed of a total of 837 laboratory confirmed cases, including 291 deaths (http://www.who.int/csr/don/2014_07_23_mers/en/).

Currently there is no antiviral therapy approved for MERS. Because of the sporadic nature of the MERS outbreak and the resulting difficulty in conducting randomized controlled clinical trials, a review of published in vitro and in vivo drug sensitivity data using cell lines and available animal models of SARS/MERS infection was conducted. Comparison of drug sensitivity was based on serum concentrations clinically achievable in humans and tolerable human dosage levels for animal models.

The drugs showing greatest activity against SARS/MERS CoV in the tests reviewed were type I interferons and an experimental interferon inducer/activator, rintatolimod (Ampligen®). Eight different type I human interferons were evaluated for antiviral activity against SARS/MERS CoV and five demonstrated activity in at least one in vitro study. Interferons approved for any indication in the US were compared, and a natural a-interferon (nIFN-a-n3), Alferon® N, was found to be the most active. Both the SARS/MERS CoVs have the ability to inhibit the production of natural type I interferon with viral proteins following infection. Thus, the pulmonary inflammation which has often been seen in humans infected by SARS/MERS CoVs may in part be secondary to a deficiency in type I interferon caused by these viruses.

The new publication also notes that treatment of humans late in the course of highly lethal coronaviral infections (MERS/SARS) is unlikely to alter the clinical course as, by then, the host immune system has already likely been severely disabled. The authors therefore recommend that clinical protocols be established to evaluate systematically various therapeutic options rather than uncoordinated treatment of infected individuals as has been employed to date.

The company met with U.S. government senior biodefense/biosecurity staff on July 30, 2014, and discussed the potential application of these and other findings to highly pathogenic/lethal human viruses including Ebola virus and the ongoing outbreak in Central Africa. The potential application of these findings to the Ebola outbreak is centered on similar mechanisms of high death rates, through the viral disablement of the body's antiviral and immune defenses.

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 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, Ebola 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.

CONTACT: Company/Investor Contact: Charles Jones CJones & Associates Public Relations Office: 888-557-6480 Cell: 305-987-7418 Email: cjones@cjonespr.com Help employers find you! Check out all the jobs and post your resume.

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