Hemispherx's Ampligen(R)/ Intranasal Flu Vaccine Program to be Presented At International...
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Hemispherx's Ampligen(R)/ Intranasal Flu Vaccine Program to be Presented At
International Vaccine Workshop in Osaka
PHILADELPHIA, Oct. 8, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE
Amex:HEB) (the "Company"), announced that Dr. H. Hasegawa, Chief, Laboratory of
Mucosal Vaccine Development Virus Research Center, Japanese National Institute
of Infectious Diseases (JIID), will review data on Ampligen(R), an experimental
immunotherapeutic, at the "Mucosal Immunity" session of the Japan-France Vaccine
and Infectious Diseases Workshop in Osaka, October 10, 2009. (Please see
http://www.osaka-u.ac.jp/en/seminar/info/2009/10/594) Dr. Hasegawa is the
Principal Investigator on the Ampligen(R)/ Influenza vaccine program under the
joint auspices of JIID/ Ministry of Health, Biken Corporation (Osaka) and
Hemispherx Biopharma. Dr. Hasegawa will provide an overview of intranasal
pandemic flu vaccine and nasal immunity mechanisms.
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.
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CONTACT: Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
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