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Hemispherx Biopharma Receives U.S. Patent Office Notification of New Patent Granted for the Use of Ampligen(R) as an Influenza Virus Vaccine Adjuvant for Protection Against Pandemic Avian Influenza

Tuesday, July 19, 2011 8:01 AM


Jul. 19, 2011 (GlobeNewswire) --

PHILADELPHIA, July 19, 2011 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company" or "Hemispherx") today announced the granting of a new United States Patent for the use of Ampligen® [rintatolimod; poly(I)·poly(C12,U)] as a vaccine adjuvant for use with seasonal influenza vaccine to induce an enhanced immune response against H5N1 avian influenza. The patent describes a method using intranasal administration of Ampligen®, a toll-like receptor 3 (TLR3) agonist, along with a seasonal influenza vaccine to enhance an immune response against a H5N1 avian influenza infection compared to the administration of seasonal influenza vaccine alone. Intranasal vaccination stimulates mucosal immunity which is characterized by a broader, and potentially more effective, immune response.

Influenza epidemics continue to represent a significant medical challenge. Even with existing vaccines, annual influenza epidemics typically result in 20-50 million cases, resulting in 30,000 to 40,000 deaths in the U.S. alone. A potential pandemic could have even more devastating consequences. The goal of the approach described in Hemispherx's new patent is to generate protective mucosal immunity against newly emerging and highly pathogenic forms of H5N1 avian influenza viruses.

FDA authorization of a clinical trial to evaluate the breadth of immunological protection in healthy volunteers, potentially conveyed by Ampligen®, an experimental therapeutic, against influenza viruses has been recently announced.

About Hemispherx Biopharma

Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical 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® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon® LDO. Ampligen® is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx's platform technology includes components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial 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® and Alferon® LDO) 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. The planning, completion, results or submission of clinical trials do not imply that any study product will ever be approved commercially for the studied or other treatment indications.

CONTACT: Company/Investor Contact:
         Dianne Will
         Hemispherx Biopharma, Inc.
         518-398-6222
         ir@hemispherx.net
(Source: PrimeZone )
(Source: Quotemedia)

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