PHILADELPHIA, Oct. 11, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) ("Hemispherx" or the "Company") offered congratulations and homage to Ralph M. Steinman (1943-2011) who shared the 2011 Nobel Prize in Physiology or Medicine with Drs. Bruce A. Beutler and Jules A. Hoffman.
Innovative research conducted by this year's Nobel Prize winner has led to greater understanding and involvement of Innate Immunity Receptors such as Toll-Like Receptors (TLRs), dendritic cells, and their immune signaling pathways that control and drive the immune response.
Professor Ralph Steinman, while director of the Center for Immunology and Immune Disease, at Rockefeller University, published in the Proceedings of the Academy of Natural Sciences ("PNAS") (105:2574-2579, 2008) data that demonstrated the unique action of Ampligen® (Poly I : Poly C12U) as a specific TLR3 activator and dendritic cell maturation agent. Other TLR3 activators reported by the Steinman team had immune stimulating activities, which were "off-target", i.e., these compounds also acted outside of the specific TLR3 activation mechanism. Prof. Steinman's team supplemented these Ampligen® results in his subsequent publication in PLoS Pathogen (5(4):e1000373, 2009). These results were independently corroborated by researchers at Utah State University (The Journal of Immunology (178:5200-5208, 2007)).
Ampligen®, an experimental therapeutic, is a flagship product within the Hemispherx proprietary platform being investigated clinically in a variety of Phase I thru Phase III clinical trials as an immunomodulatory drug, both as monotherapy as well as part of various immunologic-based cocktails. Active U.S. based clinical trials include those at the University of Pennsylvania, the University of Washington, and the CFS (Chronic Fatigue Syndrome)/Ampligen® consortium group with active clinical sites in New York City, NY, Charlotte, NC, Miami, FL, Incline Village, Nevada, and Salt Lake City, UT, and a planned (FDA authorized) study at the University of Alabama on potential protection against seasonal and pandemic influenza.
Prof. Steinman discovered, in 1973, a new type of cell, which he called the dendritic cell. He postulated that it could be important in the immune system. The remainder of his life was devoted to unraveling the complexities of this fundamental biological process. Ampligen®, an experimental therapeutic, was discovered at about the same time at Johns Hopkins University. The Ampligen® co-discoverers speculated that it might induce the body to produce interferon which plays a key role in immunity; only several decades later was its activity as the first specific TLR3 activator reported by the Steinman team in the PNAS publication. New, ongoing, research suggests that genetic variants in TLRs, especially TLR3, may be associated with an increased risk for certain chronic diseases.
In both commerce and basic research areas, many have benefited from the work of Prof. Steinman that resulted in his recognition as the 2011 Nobel laureate in Medicine. The vast potential enabled by his work for translational medicine remains to be discovered.
About Hemispherx Biopharma, Inc.
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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® (FDA approved for a category of sexually transmitted diseases) 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. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). 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® and Alferon® LDO) 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. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications. The scale-up of Alferon N manufacturing could be delayed by various critical steps including those involved in construction, GMP compliance, formulation, packaging and labeling, as well as potential issues related to 3rd party vendors including without limitation various "fill and finish" procedures.