HEMISPHERX INITIATES AMPLIGEN PHASE IIB FOR INFLUENZA.

Hemispherx Biopharma, Inc. (AMEX: HEB), has initiated a well- controlled Phase IIb trial in Australia of Ampligen(r), an experimental TLR3 ligand shown to function as an immune system activator , in combination with trivalent seasonal influenza vaccine. The trial, expected to last for several months, is occurring in Australia's winter season and focuses on populations at risk for virulent cases of influenza, especially those over the age of 60 years who may lack a robust immune system.

Recently, the Pacific region has received intensified attention by health authorities due to outbreaks of both seasonal and avian influenza and recently issued warnings by the Japanese Health Ministry on possible life-threatening side effects of the presently available front-line anti-viral therapies. New outbreaks of avian influenza have also just been reported from Vietnam.

The projected Australian clinical research on the experimental TLR3 ligand Ampligen(r) is prompted by recent exciting results from the Japanese National Institute of Infectious Diseases ("JIID") which has reported very robust immune responses in animal models when Ampligen(r) was added to either seasonal or avian influenza vaccines. The JIID has also reported a wholly new therapeutic property - strong cross-protection against mutated variant flu viruses, including avian strains - when the experimental TLR activator was co-administered with the vaccine. The JIID studies administered the Ampligen(r)/vaccine combination intranasally versus the Australian regimen's subcutaneous administration. Thirty (30) patients will be enrolled in the study which will utilize a dose of Ampligen(r) of only 2mg, or 1/200 of the dosage used in Chronic Fatigue Syndrome (CFS) studies.

The U.S. Food and Drug Administration ("FDA") and regulatory agencies worldwide have just recently announced new guidelines (see FDA.gov) for accelerated approval of influenza vaccines and adjuvants, such as TLR3 ligands. In essence, the presumption of efficacy may now be established by examining for specific antibodies in the sera of treated individuals rather than waiting for disease outbreaks and pursuing much more protracted clinical endpoints during these episodic outbreaks. To operate within these guidelines, Hemispherx has already identified qualified independent testing labs in both the U.K. and Australia to monitor subjects' immune responses. Measurements of initial immune response are expected to occur within several weeks. Human safety studies will still be required for accelerated licensure, and Hemispherx expects to contribute its large dossier on Ampligen (r), being compiled in connection with its pending NDA for CFS, to expand the safety database.

Dr. William Carter, CEO/Chairman of Hemispherx commented, "We are particularly excited to initiate these influenza vaccine clinical tests for two reasons: first, they represent a major clinical extension of the outstanding pioneering research being conducted by Dr. Hasegawa and associates at JIID on combination therapy to combat a wide range of influenza strains. Second, they may establish a new route of administration of our experimental TLR3 ligand Ampligen. If JIID results can be confirmed, health authorities would be able to co-administer Ampligen with vaccine, dramatically conserving available vaccine supplies while still accomplishing a life-saving therapeutic mission."

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is a biopharmaceutical 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) and the experimental therapeutics Ampligen(r) and Oragens(r). Alferon N Injection(r) is approved for a category of STD infection, and Ampligen(r) and Oragens(r) represent experimental RNA 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 severely debilitating and life threatening diseases. Hemispherx has in excess of 100 patents comprising its core intellectual property estate, a fully commercialized product (Alferon N Injection(r)) and GMP certified manufacturing facilities for its novel pharma products.

For more information, visit http://www.hemispherx.net or call 310/477-9800, ext. 129.