PHILADELPHIA, Dec. 27, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) reported today that the National Horizon Scanning Centre of the Department of Public Health and Epidemiology at the University of Birmingham, United Kingdom, has published a comprehensive "Report on CFS" (issued Dec. 15, 2007). The report focuses on the growing problems in the UK associated with Chronic Fatigue Syndrome, with specific attention given to Poly I: Poly C12U (Ampligen(r)), an experimental therapeutic developed by Hemispherx as a potential aid in fighting the disease.
Prepared for the UK Dept. of Health and the National Institute for Health and Clinical Excellence (UK), the most recent report is based on relevant guidance documents recently prepared by government and government-related organizations. These documents specifically discuss the medical management of CFS. Among those cited in the most recent report are those by the UK Dept. of Health (issued yr. 2007), National Institute of Health (issued yr. 2005), and the Royal College of Pediatrics and Child Health (issued Dec. 2004).
The UK report estimates that between 26,865 and 53,729 people in England and Wales, respectively, are "severely affected" with CFS. It recognizes Ampligen(r), an experimental therapeutic, as a new class of toll-like receptor 3 agonist drugs that would, if licensed, be the first pharmaceutical treatment for CFS.
During the 2008 calendar year Hemispherx plans to begin the commercial application process for introducing Ampligen(r) as a CFS therapeutic in the European Community. Only regulatory agencies can determine whether any experimental therapeutic, including Poly I: Poly C12U (Ampligen(r)) is "safe and effective"; at this time, Ampligen(r), an experimental therapeutic, is only available in specific clinical trial settings conducted under specific governmental authorizations and has not been determined to be "safe and effective" by any governmental body.
Mr. Anthony Bonelli, President and Chief Operating Officer of Hemispherx Biopharma, Inc., which developed Ampligen(r) in conjunction with researchers at The Johns Hopkins University, commented, "Certainly this UK report greatly increases the public's awareness that Chronic Fatigue Syndrome is a growing problem worldwide, and not just a problem in the U.S. It underlines how burdensome are the human and economic costs of this debilitating disease, regardless of geography. That the UK report gives special attention to the potential benefits from our program is noteworthy."
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced biopharmaceutical 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(r) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(r) and Oragens(r). Ampligen(r) and Oragens(r) represent experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has in excess of 100 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit http://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, change 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. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen(r), Alferon LDO and Oragens) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications.