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Hemispherx Biopharma to Present at The First International Conference on Avian Influenza in Humans at the Pasteur Institute; Novel Therapeutic Approach Attacks Virus at 3 Levels Simultaneously

Posted on: Tuesday, 27 June 2006, 09:00 CDT

Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that Mr. Richard Piani, Lead Director on the Board of Hemispherx, will be presenting at the First International Conference on Avian Influenza in Humans at the Pasteur Institute in Paris, France, June 29 and 30. The findings being presented provide new evidence that the Company's Alferon LDO (Low Dose Oral), a new delivery form of an anti-viral with prior regulatory approval for a category of sexually transmitted diseases, has significant potential in resisting the spread of avian influenza by stimulating genes that induce the production of immune compounds which are key building blocks in the body's defense system.

The findings arrive in an environment where the threat from avian flu continues to mount. Several days ago, U.N. bird-flu experts announced that the recent 100% death rate in an Indonesian cluster was associated with new viral mutations in the flu genome.

Early Alferon LDO data were presented at the VIII International Symposium on Respiratory Viral Infections in March 2006. Significance has been reinforced at this time and in this venue due in part to a recent major editorial by Dr. Luc Montagnier, co-discover of the AIDS virus (HIV) and himself a member of the Pasteur Institute. In the article, Judging the Threat of Avian Flu and Mobilizing Our Natural Defenses, Dr. Montagnier leverages his experience and expertise with viruses and epidemics against the looming threat of avian influenza and declares that we are in a race that we must win, "to sufficiently mobilize the interferon system early enough so that it will knock out the virus multiplication before that virus launches its dangerous missile against interferon". Dr. Montagnier goes on to identify Alferon LDO as the prime experimental drug candidate for this task.

Researchers in this area have recently focused on the tumor necrosis factor (TNF), a naturally occurring immune substance (or lymphokine), as the instigator of the massive tissue damage to lung cells that occurred in the Spanish flu epidemic of 1918. Current research, including analysis of avian flu virus specimens recovered in the frozen artic tundra from victims of the 1918 avian flu epidemic, suggests that the interferon system, the body's primary line of defense, broke down first, leading to the aberrant and ultimately self-destructive uncontrolled release of TNF.

In tests being conducted in Hong Kong and Philadelphia with healthy volunteers, patients were given graded doses of Alferon LDO for two minutes' exposure sublingually. Blood samples were thereafter taken to determine which components of the immune system had been activated. It was found that the interferon gene activities, normally suppressed or killed by the virus, were instead enhanced several times over. By contrast, the TNF gene battery normally enhanced by viral infection was instead sharply suppressed by the brief Alferon LDO exposure.

Thus, the new results indicate 3 levels of Alferon LDO action which can potentially block the lethality of avian influenza: Level 1) activating dormant antiviral genes; Level 2) activating immune enhancer genes, thereby mounting antibody attacks upon the avian influenza virus; Level 3) neutralizing the toxic by-product of the infection, TNF, thereby preventing sudden respiratory death.

About Hemispherx

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 disorders. Hemispherx Biopharma's flagship products include Alferon(R) and the experimental immunotherapeutics/antivirals Ampligen(R) and Oragens(TM). Alferon(R) is approved for a category of STD 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 viral infections. Hemispherx has in excess of 100 patents comprising its core intellectual property estate, a fully commercialized product (Alferon(R) N) and GMP 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), Alferon(R) 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(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications.


Source: Business Wire

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