Hemispherx Highlighted in Study of Innate Immunity as a Defense Against Bio-terror Threats; Ampligen(R) and Alferon(R) Featured in the December 2005 Journal of Allergy and Clinical Immunology.PHILADELPHIA -- Hemispherx Biopharma, Inc. (AMEX AMEX See: American Stock Exchange : HEB HEB Hebrew HEB Hurst-Euless-Bedford (Texas) HEB Hot Electron Bolometer HEB Hindu Endowments Board (Singapore) HEB Here Everything's Better HEB High-Energy Beam HEB High Energy Biscuit ) announces that research published by an academic consortium led by The National Defense University (U.S.A.) in the Journal of Allergy and Clinical Immunology The Journal of Allergy and Clinical Immunology is a scientific journal in the field of allergy and immunology, with an emphasis on clinical relevance. It's the official journal of the American Academy of Allergy, Asthma, and Immunology. (JACI JACI Journal of Allergy and Clinical Immunology ) (December issue) titled "Innate Immunity for Biodefense: A Strategy whose Time has Come" have found that Hemispherx products Alferon N(R) and Ampligen(R), are among a small pool of agents that stimulate innate immunity for the defense against a bio-terror attack. The study concluded that an adequate defense would require a broad-spectrum approach to combat deadly pathogens, such as the H5N1 virus. Alferon N(R) and Ampligen(R) have shown the greatest ability to stimulate the innate immune system
According to the authors, in the event of a bio-terror attack, an immediate and efficient response is required to save lives. Due to the continuous mutation of deadly agents used in bio-terror, vaccines are limited by the inability to predict the infectious pathogen, resulting in an inherent immune response delay that renders it inadequate for protection from a bio-terror attack. The JACI study demonstrated that in order to combat this, an agent that produces a broad-spectrum approach, like Alferon N(R) and Ampligen(R), is required to combat the wide range of deadly pathogens that could be used in a bio-terror attack. Innate immune cells use pathogen recognition receptors to recognize infectious pathogens and promote a rapid response against them. Toll-Like Receptors (TLR TLR Trailer TLR Toll Like Receptor (immunological research) TLR Temple (University) Law Review TLR Twin Lens Reflex TLR Texas Law Review TLR The Last Resort (gaming clan) ) have been identified as the key pathogen recognition receptors in innate immunity. Ampligen(R) (polyI polyC12U), a synthetic double stranded RNA RNA: see nucleic acid. RNA in full ribonucleic acid One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic , induces Toll Like Receptor-3(TLR3) which studies show result in the greatest increase of innate immunity over other compounds tested to date. Ampligen(R) has already been tested against more than 25 viruses and will be used in Advanced Biosystems proposal for inhaled interferon in conjunction with Alferon N(R). Alferon N(R), a natural interferon, utilizes a broad-spectrum antiviral approach and offers various binding affinities that yield greater antiviral activity. Another company mentioned in the study, Coley coley Noun Brit an edible fish with white or grey flesh [perhaps from coalfish] Pharmaceutical Group, is working with Harvard University in a program which also utilizes Ampligen(R). The Harvard synergistic platform combines a Coley product and double-stranded RNA, Ampligen(R). Both Alferon N(R) and Ampligen(R) have a generally well tolerated safety record and have shown no evidence to date of the inflammatory reactions shown in other innate immunity combinational studies. Alferon LDO (Low Dose Oral)(TM) was also noted on the basis of animal studies that suggest that oral interferon might be active at much lower doses than when administered parenterally. "It is expected that oral doses will be 1000 times lower than those already FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. approved for parenteral administration." Hemispherx's products have recently attracted attention from companies and governments looking for therapeutics to use as an adjuvant with their products for the defense of avian influenza. The Defence R&D Canada - Suffield (DRDC DRDC Defence Research and Development Canada (Science and Technology R&D for National Defence) DRDC Dairy Research and Development Corporation DRDC Denver Reception Diagnostic Center (Department of Corrections) ), an agency of the Canadian Department of National Defence, has recently signed a contract to evaluate the antiviral efficacy of Ampligen(R) and Alferon N(R) for protection against the human respiratory influenza virus infection. In addition to the DRDC Suffield collaboration, Hemispherx is also engaged in broad-based ongoing experimental studies assessing the efficacy of their products Ampligen(R), Alferon N(R) and Alferon LDO(TM) as an adjuvant or single agent antiviral with the National Institute of Infectious Diseases in Tokyo, the Princess Margaret Hospital There are several Princess Margaret Hospitals :
Alferon N(R) is already commercially approved for another major viral infection, chronic refractory HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) , and Ampligen(R) has recently completed Phase III clinical testing for Chronic Fatigue Syndrome chronic fatigue syndrome (CFS), collection of persistent, debilitating symptoms, the most notable of which is severe, lasting fatigue. In other countries it is known variously as myalgic encephalomyelitis, chronic fatigue and immune dysfunction syndrome, and . About Hemispherx Biopharma Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based chronic disorders. Hemispherx's flagship products include Alferon and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon is approved for a category of STD (Subscriber Trunk Dialing) Long distance dialing outside of the U.S. that does not require operator intervention. STD prefix codes are required and billing is based on call units, which are a fixed amount of money in the currency of that country. infection, and Ampligen(R) and Oragens(TM) represent experimental nucleic acids being developed for globally important viral diseases and disorders of the immune system. Hemispherx's platform technology includes large and small agent components for potential treatment of various chronic viral infections. Hemispherx has in excess of 140 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N) and GMP GMP (guanosine monophosphate): see guanine. certified manufacturing facilities for its novel pharma 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) and Oragens(TM)) 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(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications. |
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