FDA Plays

[colorofmoney]

HEB NEWS!!!Japanese NIH Research Reaffirms and Expands Pandemic Flu Protection by Ampligen(R)
New Data At Recent "Mucosal Immunity" International Workshop in Osaka Suggest Alternative Method to Protect At High Risk Groups

* Press Release
* Source: Hemispherx Biopharma, Inc.
* On 8:15 am EDT, Thursday October 15, 2009

Companies:
o Hemispherx Biopharma, Inc.

PHILADELPHIA, Oct. 15, 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), expanded the 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 provided an overview of intranasal pandemic flu vaccine (H5N1) and nasal immunity mechanisms.

The new data consist of both expanded clinical and anatomical findings in macaque monkeys exposed to the most virulent forms of pandemic influenza (H5N1). Standard human seasonal influenza vaccines -- given alone and having no benefit on H5N1 influenza virus pathology and clinical status -- were nonetheless highly effective against pandemic virus when combined with Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic, which was applied intranasally in very small doses, in a prophylactic treatment setting.

According to various sources, pandemic influenza vaccines will be in very limited supply on a global basis. Thus, many countries are not expected to be able to access significant pandemic vaccines stock piles. In contrast, the sources of seasonal human influenza vaccines are much more abundant and readily accessible. Hemispherx's goal is to expand the observations of JIID into other countries including the South American continent where relevant clinical vaccination protocols are being actively developed for the current pandemic H1N1 influenza virus. According to WHO's (World Health Organization) Initiative for Vaccine Research, in some countries only 10% of the population will have access to pandemic vaccine.

According to Dr. Hasegawa's research including that 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 (in addition to the above referenced cross-protection) 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.

A description of the vaccine manufacturing technology can be accessed on the Hemispherx web site, announcement of October 8, 2009.

Avian influenza (H5N1), endemic in the Pacific Rim countries, has a greater than 60% death rate in human transmissions to date while the current swine flu (H1N1) death rate is much lower (please see www.flucount.org: swine flu count- world wide statistics of the H1N1 Influenza Pandemic). Moreover, H5N1 requires only a mutation to allow primary recognition of human cell receptors for easy transmission. The research in the monkey model suggests that even when the lethality genes are concentrated in the influenza virus (e.g., avian H5N1), Ampligen(R) (Poly I: Poly C12U), an experimental therapeutic, continues to conveys an effective preventative regimen.

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.