PHILADELPHIA, May 26, 2015 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) (the "Company" or "Hemispherx") announces that the European Medicines Agency (EMA) has published on May 22, 2015 both its Public Opinion Summary (http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2015/05/WC500187066.pdf) and its record designation (http://ec.europa.eu/health/documents/community-register/html/o1480.htm) approving the Orphan Medicinal Product Designation for Ampligen, also known as rintatolimod, an experimental therapeutic, to treat Ebola Virus Disease (EVD).
The EMA opinion states that the experimental drug, "… is made up of two synthetic molecules of RNA (a type of genetic material), which are attached together. It is thought that the medicine works in two ways; first, by stimulating cells involved in the body's innate immune system (via receptors known as TLR 3), and secondly, by stimulating the production of interferons, a group of signalling proteins involved in protecting the body against viruses."
Thomas K. Equels, Executive Vice Chairman, states, "The European Medicines Agency rationale for designation of our experimental drug Ampligen®/Rintatolimod as an orphan drug is helpful to understanding our path forward seeking commercial approval of Ampligen® (rintatolimod) as a prophylactic and early onset therapeutic for Ebola and other lethal viral diseases. Accordingly, the Public Summary Opinion and the designation have both been posted on our website to facilitate public review of the actual documents." The EMA orphan drug designation Public Opinion Summary will be posted on the Company website www.hemispherx.net.
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. Ebola virus specifically inhibits the dsRNA within cells via a sequestration process. Such RNA would otherwise cause a robust antiviral response to be mounted: Ampligen® may be able to overcome this deficiency in host response. Positive results against Ebola in vitro, and/or in an animal model, have been reported to the Company by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and other research/academic institutions in the US and abroad. However, in vitro and animal testing is no assurance of human safety or efficacy for EVD, positive results from a non-human primate (NHP) study may be required before initiation of human clinical testing of Ampligen® in patients with EVD. Clinical studies would also be necessary to establish human efficacy and safety of Ampligen for either treatment and/or prevention of EVD. Clinical safety and tolerability data obtained for one indication, for example, CFS, may be different for another disorder like EVD. Clinical protocol development is being pursued.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the manufacture and clinical development of new drug entities ("biological modifiers") for treatment of seriously debilitating disorders especially life-threatening viruses. 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 including cancers. 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 FDA approval of Alferon® N Injection® is limited to the treatment of refractory or recurrent external genital warts in patients 18 years of age or older. The Company's Alferon N Injection® 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
The information in this press release includes certain "forward-looking" statements including without limitation statements about additional steps which the FDA may require and Hemispherx may take in continuing to seek commercial approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome in the United States. The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of an Ampligen® NDA in the United States and other countries. Any failure to satisfy the FDA regulatory requirements or the requirements of other countries could significantly delay, or preclude outright, approval of an Ampligen® NDA in the United States and other countries.
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 could vary materially from Hemispherx's expectations. Findings from animal studies may not correlate with results from humans. Clinical trial data will be necessary to establish human efficacy of Ampligen® or Alferon® for Ebola virus disease.
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 "intends," "plans," 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. No evidence is suggested that Alferon® N, Alferon® LDO and/or Ampligen® will ever be commercially approved for the new potential treatment indications mentioned in this release.