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Hemispherx Biopharma Announces Influenza Vaccine/Immunopotentiation Clinical Trials Designed to Increase Vaccine Dosage Supply and Increase Cross-Protection

Posted on: Monday, 15 May 2006, 09:03 CDT

Hemispherx Biopharma, Inc. (AMEX: HEB) today announced that it has procured the seasonal influenza vaccine it needs to execute a well-controlled (Placebo vs. Ampligen(R)) immunopotentiation clinical trial. This Phase II clinical trial will be conducted in Australia, where seasonal flu vaccination programs are already well underway for the fall/winter flu season.

These trials may have broad-ranging implications due to changes in the overall seasonal flu treatment environment. The US Advisory Committee on Immunization Practices (ACIP) recently selected two new strains for use in the current vaccine. This marks a major change in vaccine composition, and could have a negative affect on the production and availability of next season's vaccine.

Recent preclinical studies reported at biodefense and international influenza symposia suggest that Ampligen, an experimental immunotherapeutic developed by Hemispherx Biopharma, may achieve at least two major therapeutic benefits when co-administered with influenza vaccines. First, in studies conducted with the Japanese National Institute of Infectious Diseases (JNIID), protective antibody levels increased up to 100-fold against seasonal influenza viruses. Second, using highly pathogenic lethal avian influenza viruses (HPIV) the JNIID researcher found that when co-administered with HPIV vaccines, Ampligen provided cross-protection against variant HPIV strains 100-300 fold.

These are the first scientific reports of potentiation and cross-protection of this magnitude with human or avian influenza viruses. The objective of the approximately 60-patient clinical study in Australia is to extend the findings from the preclinical models to determine the extent to which Ampligen(R) may increase the effectiveness of vaccines, and thereby broaden the availability of flu vaccine doses to treat more at-risk groups, such as immuno-comprised patients and senior citizens.

As a result of the two new flu virus strains selected for the 2006-2007 season, the total number of doses to be produced for the upcoming flu season is subject to uncertainty, according to a recent Reuters report that quotes leading vaccine manufacturers. Hemispherx Biopharma's clinical programs in flu vaccine use are designed to eliminate and/or mitigate the growing vaccine supply problems.

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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