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According to public sources, the first swine flu vaccines (e.g., "Flu Mist") are scheduled for delivery in the United States this week. As intranasal vaccines, their initial use is targeted for high risk populations. The intranasal vaccine production technology utilized in the referenced mucosal influenza immunity program by JIID is also licensed from the U.S. based manufacturers of "Flu-Mist" (via various license and operating agreements with and between Biken Corporation and the Japanese Ministry of Health). To the Company's knowledge, no pandemic influenza vaccines have yet been approved and distributed in Japan.
According to Dr. Hasegawa's peer reviewed published research including an Abstract recently published at the Sapporo, Japan, Vaccinology Conference, Ampligen(R) (Poly I : Poly C12U) an experimental immunotherapeutic and centerpiece of a mucosal immunity program, may convey two additional biological properties when co-administered intranasally with pandemic flu vaccines: 1) the enhancement of immunity with higher IgA and IgG levels which may convey a survival/therapeutic advantage in animal model systems, and 2) the potential to widen the therapeutic (preventative) profile by protecting against a phenomenon known as "antigenic drift" in which the pandemic virus may escape the preventative effect of the vaccine; this phenomenon is well-established with avian H5N1 virus and mitigated the potential effectiveness of various influenza vaccines manufactured several years ago in the U.S.A.
Animal model experiments do not necessarily predict biological behavior in man. Regulatory agencies are the only governmental entities vested with the authority to determine whether biological products and experimental therapeutics may be deemed safe and effective for use in a human population.
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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) Oragens(R), and Alferon LDO. Ampligen(R) and Oragens(R) represent experimental RNA nucleic acids being developed for globally important debilitating 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 50 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(R)). 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(R), Alferon(R) LDO and Oragens(R)) 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; Similarly, the completion of NDA filing process with Ampligen(R) does not imply that the product will ever be approved commercially.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Hemispherx Biopharma, Inc.
CONTACT: Hemispherx Biopharma, Inc. Company/Investor Contact: Dianne Will 518-398-6222 ir@hemispherx.net
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