PHILADELPHIA, June 2, 2008 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today reported that it has completed enrollment in a Phase II clinical trial to evaluate the safety and efficacy of Ampligen(r) as an enhancer for seasonal influenza vaccine.
Participating in the single-center study in Australia are 38 healthy volunteers between 60 and 80 years of age who have not received this year's seasonal flu vaccine. Study subjects will be randomized into groups receiving vaccine plus Ampligen(r) or vaccine plus a placebo. Under the double-blind structure of the trial, neither study subjects nor clinicians conducting the trial will know which subjects are receiving Ampligen(r) or placebo until final results are recorded.
As reported in the Journal of the American Medical Association in 2003 by Thompson, Shay, Weintraub, Brammer, Cox, Anderson, et al, seasonal influenza kills approximately 36,000 Americans annually, most over the age of 70. In 2004 in JAMA, the same authors attributed 200,000 U.S. hospital admissions annually to seasonal flu.
Secondary goal: Study cross-protection against Avian Influenza
A secondary goal of the trial is to evaluate whether antibodies stimulated by the vaccine/Ampligen(r) combination also provide protection against H5N1, the avian influenza virus. Since 2003, the World Health Organization has attributed 241 human deaths worldwide to H5N1. Investigators from Japan's Institute of Infectious Diseases have conducted studies in animals that suggest that Ampligen(r) can stimulate a sufficiently broad immune response to provide cross-protection against a range of virus strains, including H5N1.
If Ampligen(r), an experimental therapeutic, proves effective as a vaccine enhancer for traditional seasonal flu vaccines, which must be formulated each season based on each season's prevailing strain of seasonal influenza, it would help to ease the perennial shortage of seasonal vaccines and extend their ability to provide protection against mutated strains of any year's target virus.
A Company spokesperson commented, "An effective enhancer for seasonal influenza vaccine would be a significant aid to public health, especially among the elderly. In each flu season, it is the elderly who are among the subsets of the population who suffer severe and disproportionate mortality from seasonal flu. Building upon findings in animal models, the Company hopes to establish that Ampligen(r), an experimental therapeutic, may provide cross-protection against a virus species which poses the looming pandemic threat of killing not just the elderly, but healthy people in the prime of life: H5N1 avian influenza. Such cross-protection is suggested by animal studies conducted by the Company's clinical collaborators in Japan at the Japanese National Institutes of Health."
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 90 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(r)) 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; Similarly, the completion of NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.