PHILADELPHIA, Sept. 23, 2008 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) reported that at the Third European Influenza Conference in Portugal (September 14-17, 2008), members of the National Institute of Infectious Diseases, Japan, reported on the expanded potential role of Ampligen(r) in preventing bird flu. The paper is entitled: "The TLR3 agonist, poly I : poly C12U (Ampligen(r)) added to influenza vaccines as a nasal adjuvant induces a wide spectrum cross-protection against different subtypes including highly pathogenic H5N1 avian influenza virus." Ampligen(r) is an experimental therapeutic and a flagship product of Hemispherx.
Simultaneously, researchers at the Japanese National Institute of Animal Health reported in the current issue of Emerging Infectious Diseases (Vol.14, No. 9, Sept; 2008), published by the Centers for Disease Control ("CDC"), a new outbreak of highly pathogenic avian influenza virus (H5N1) in whooper swans. The scientists note that it is a new strain of HPAIV "distinguishable from HPAIVs that caused previous outbreaks." Consequently, existing HPAI vaccines are expected to be of little help.
Hemispherx has licensed Biken on a nasally delivered H5N1 vaccine using Ampligen(r) and is collaborating with Dr. H. Hasegawa of NIID, Japan. Hemispherx representatives are in discussions designed to determine the potential role of Ampligen(r) as an addition to the National Strategic Stockpile in Japan.
Ampligen(r), an experimental product, may stimulate nature's primary gateway to immune enhancement, mediated by receptors termed "toll-like receptors" (TLRs). Ampligen(r) has been generally well-tolerated in humans in extensive clinical trials in contrast to other TLR activators. This is believed to be due to the unique internal signal pathways for TLR3 and the short half-life of Ampligen(r). Other immuno-enhancers may work downstream from the TLRs immune "gateways" at so-called "checkpoints". Since "checkpoints" are not normally part of nature's own immune-defense surveillance apparatus, these alternative "checkpoint" strategies may be associated with unintended consequences including significant toxicities.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma 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 issued 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 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; Similarly, the completion of NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.