Japan's National Institute of Infectious Diseases Widens Research On Hemispherx's Ampligen, An Immune Enhancer, Co-Administered With a Vaccine in AIDS Research

Intranasal Vaccination for HIV-1 Utilizing Ampligen as An Immuno Enhancer Holds Promise


PHILADELPHIA, Sept. 10, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today announced that Japan's National Institute of Infectious Diseases (NIID) has extended its relationship with Hemispherx Biopharma to initiate research on the intranasal co-administration of NIID's HIV-1 vaccine with Hemispherx's experimental TLR3 agonist and immune enhancer, Ampligen(r) (Poly I; Poly C12U). This research takes its cue from earlier successful research suggesting an effective role for Ampligen(r) in boosting certain vaccines that combat H5N1 (avian influenza or "bird flu") as well as seasonal influenza viruses.

The NIID's interest is to identify an effective and safe immune enhancer which activates a robust mucosal immune response. The hope and expectation is for Ampligen(r) to overcome the historical problem which has handicapped AIDS vaccine development worldwide, namely marginal immune response which undermines the potential of long-lasting protection. Ampligen(r), an experimental immunotherapeutic, will be combined with HIV recombinant protein and administered via an intranasal route. Once antibodies are produced, the NIID team will further analyze neutralizing and protective activity.

As was previously disclosed this year, Japan's Ministry of Health, Labor and Welfare (MHLW) issued authorization to the NIID approving its budget to advance studies indicating that an H5N1 influenza vaccine co-administered intranasally with Hemispherx's experimental TLR3 agonist Ampligen(r) protected against mutated strains of the virus, and that the seasonal trivalent influenza vaccine co-administered intranasally with Ampligen(r) maintained efficacy even when challenged with the H5N1 influenza virus. Peer reviewed publications on these advances are expected shortly.

Dr. William A. Carter, Chairman and CEO of Hemispherx, stated, "We are thrilled and excited by the Japanese NIID's interest in studying our TLR3 agonist, Ampligen(r), as a potential immune enhancer to be co-administered with their HIV vaccine. The prospects for Ampligen(r) together with vaccines are too vast for Hemispherx to pursue on our own, so we welcome collaborations such as this to advance the drug's opportunities in viral disorders, cancer and allied conditions."

Hemispherx is currently preparing a New Drug Application (NDA) to be submitted to the FDA for the use of Ampligen(r) as a prospective, monotherapy treatment of Chronic Fatigue Syndrome (CFS), specifically to improve physical performance and quality of life in this severely debilitating condition. Presently CFS is without a recognized therapeutic intervention in any of the world's major pharmaceutical markets.

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 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 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.



            

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