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New Report Illuminates Ampligen's Unique Mechanism of Action

PHILADELPHIA--(BUSINESS WIRE)--Apr 30, 2007 - Hemispherx Biopharma, Inc. (AMEX: HEB) announced today the first scientific publication (Journal of Immunology, April 2007) that explains the unique therapeutic properties of its proprietary experimental therapeutic, Ampligen(R) (Poly I : Poly C(12)U), a double-stranded RNA being tested as a monotherapy for Chronic Fatigue Syndrome and as an adjuvant to other drugs and vaccines.

The new peer-reviewed study shows conclusively that the biologic properties of Ampligen(R) are conveyed exclusively by a unique naturally occurring receptor on the cell surface called "TLR-3." Toll-like receptors or "TLRs" such as TLR-3 serve as "pattern recognition" receptors in the early detection of pathogens and the establishment of early defense mechanisms (innate immunity). As such, they are critical to the first line of immunological defense against a broad range of pathogens, such as otherwise lethal viruses and even various forms of cancer.

When the dormant alarm signals of TLRs are activated (as by exposure to a pathogen or a stimulant agent such as Ampligen(R)), TLRs in effect cause an overreaction, driving the body to proliferate broad-spectrum defenses against many types of pathogens.

New research shows that these receptors present in virtually all life forms, from mosquitoes to man (in scientific terms, they are remarkably "evolutionarily conserved"). This suggests that TLRs are critical to retaining healthy life in a constantly changing environment full of hostile pathogens, many of which the subject has never encountered before.

The study was conducted in TLR-3 "knockout" animals at Utah State University under a NIH contract and with the aid of a variety of collaborators representing a consortium of institutions (Yale University, Vanderbilt University, and the Centre d'Immunologie de Marseille-Luminy), to determine if TLR-3 is essential for the activities
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