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Nobel Laureate Confirms Importance of Adjuvants in Controlling Devastating Diseases PHILADELPHIA, Oct. 23, 2008 (GLOBE NEWSWIRE) -- Hemispherx
Biopharma, Inc. (AMEX:HEB - News) noted today that a member of
its Scientific Advisory Board, Prof. Luc Montagnier, a winner
of the 2008 Nobel Prize in Physiology and Medicine, confirms
the importance of adjuvants in a current article in the
Wall Street Journal (Oct. 21, 2008, p.A19). In his article
entitled ``The Next Steps to Take in Beating AIDS'', Prof.
Montagnier, indicates that ``after partial restoration (...of
the patient's immune system) by an antiretroviral treatment...at
the same time the immune system should be fully restored
with proper adjuvants.'' Hemispherx's experimental biotherapeutic, Ampligen(r), is a well studied adjuvant which selectively produces maturation of key components of the immune system necessary to bring about ``immunosurveillance''. This experimental biotherapeutic appears to operate exclusively thru a set of naturally occurring alarm signals on human cells termed ``TLR3 receptors''. In his article, Prof. Montagnier emphasizes the need to induce natural immunity to ``remove the burden of life-long drug therapy and prevent HIV infection from evolving into a disease''. As a further illustration, he suggests: ``We want to extend what Mother Nature bestows upon a few lucky individuals (infection without disease) to a majority of patients.'' Hemispherx has recently submitted a New Drug Application (NDA) for potential use of the experimental product Ampligen(r) to treat Chronic Fatigue Syndrome (CFS) in the U.S., to be discussed at the upcoming ICAAC Conference in Washington, D.C. Prof. Montagnier is also a long term advocate of the potential use of another Hemispherx experimental biotherapeutic, Alferon LDO, in catastrophic viral infections, such as HIV, especially for developing African nations. Earlier, referring to the recent threat of avian influenza in Forbes.com, Prof. Montagnier commented: ``This is the race we have to win: to sufficiently mobilize the interferon system early enough so it will knock out the virus multiplication before the virus launches its dangerous missile against interferons. One prime candidate for this task already exists. It's a substance called Alferon LDO.'' Alferon LDO, (Low Dose Oral Interferon Alfa-n3, Human Leukocyte Derived), is Hemispherx's experimental, oral-delivery form of the Company's FDA-approved drug, Alferon N Injection(r), indicated for treatment of refractory HPV infection. Alferon N is the only natural interferon which is FDA approved for any disease. As part of its mechanism of action, Alferon N also serves as a ``co-stimulatory'' molecule to increase the robustness of ``immuno-surveillance'' to reduce the chance of disease recurrence. Hemispherx has initiated clinical trials as part of an evaluation of Alferon LDO as a potential new experimental therapy for HIV/AIDS and other lethal viral diseases including avian influenza (``bird flu''), which have very high death rates. Clinical trials in early HIV infection have been conducted in the U.S. with the AIDS research organization termed ``Philadelphia Fight'', as well as in Hong Kong at the Princess Margaret Hospital utilizing Alferon LDO with healthy volunteers to measure natural immune boosting capabilities. Overall, the studies are designed to determine whether Alferon LDO, delivered in the new, experimental oral (sublingual) drug delivery format can resuscitate the broad-spectrum antiviral and immunostimulatory genes. These human genes are often shut down by lethal viral infections such as avian flu, smallpox, and HIV/AIDS as noted in Dr. Montagnier's article in Forbes.com. Recent studies conducted at the Japanese National Institutes of Infectious Diseases have also established that Ampligen(r), an experimental therapeutic, can function as an effective adjuvant by various routes of administration including oral (intranasal) delivery. Dr. Montagnier is Chairman of the World Foundation for AIDS Research and Prevention, which he co-founded in 1993, and holds the position of Distinguished Professor at Queens College in New York. 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. Ampligen(r) and Oragens 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 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) 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 the NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially. Contact: Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
CCG Investor Relations
Sean Collins, Sr. Partner
310-477-9800
Source: Hemispherx Biopharma, Inc.
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