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Dr. Mitchell will present data on the structure/function properties of the TLRs and the development of TLR ligands as pharmacologic agents. Detailed clinical examples of the TLR3 activator, Ampligen(r), will be presented. These examples include Chronic Fatigue Syndrome (CFS), vaccine immune enhancers (i.e.- highly pathogenic avian influenza and cancer), and inhibition of cancer (renal cell carcinoma).
Hemispherx Biopharma has filed a new drug application (NDA) for the treatment of CFS that is under active review by the FDA and presently maintaining a schedule with various reporting milestones previously announced by the Company in early summer 2008. Collaborative efforts continue with academic investigators, government, and industry for conduct of tests leading to a potential commercial product in Japan as part of a vaccine against highly pathogenic avian influenza. Current clinical trials in Australia are evaluating the ability of Ampligen(r) to enhance the immune response to seasonal influenza vaccine in the elderly who frequently remain at risk for influenza pneumonia despite yearly vaccination. Collaborative efforts to potentiate cancer vaccines are also underway with various centers of excellence in cancer research across the United States.
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.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Hemispherx Biopharma, Inc.
Hemispherx Biopharma, Inc. Investor Contact: Dianne Will 518-398-6222 ir@hemispherx.net CCG Investor Relations Sean Collins, Sr. Partner 310-477-9800
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