PHILADELPHIA, May 21, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE Amex:HEB) announced that it has learned that Japan's Council for Science & Technology Policy (CSTP) awarded to the National Institute of Biomedical Innovation (NIBIO) funds to advance research with influenza vaccines utilizing a new experimental adjuvant, Ampligen(r) (Poly I: Poly C12U). The CSTP laid open in 2008 competition of industry-academia-government institutions to apply for its authorization of Innovative Technology awards. The CSTP has elected 24 applications out of 143, and authorized the research budget as "Innovative Technology". The CSTP is a cabinet office position reporting to the Prime Minister of Japan.
NIBIO's research entitled "Innovation Project for Anti-infectious vaccines in Next Generation" is aimed at the development of high-value-added vaccines for various infections such as pandemic influenza, malaria and AIDS. With regards to influenza vaccines in particular, NIBIO has worked jointly with researchers at the National Institute of Infectious Diseases (NIID), with whom Hemispherx has been collaborating in various studies. NIBIO / NIID common goal is to develop the pandemic influenza vaccine formulated with an adjuvant, Ampligen(r), an experimental therapeutic, to be administered by intranasal routes. They expect the intranasal vaccine may exert broad cross protection against the mutated viruses of pandemic influenza based on results to date.
Study of this unique vaccine preparation combined with Ampligen(r) (Poly I: Poly C12U), an experimental therapeutic, started in April 2007 under a research grant by Japan's Ministry of Health, Labor and Welfare (MHLW). The efforts in the last 2 years are now culminating in encouraging results in rodents and monkeys wherein a dramatic increase of IgA secretion was found which leads to a broadly cross-protective effect against various pandemic influenza strains.
Hemispherx indicated that a "universal vaccine", to protect potentially against shifted wild-type strains, like the swine flu strain, would need to recognize conserved sequences among different strains of influenza vaccines. "Universal vaccines" might be effectively used against shifted strains such as the current swine flu strain which is a shifted strain of HINI virus included in the trivalent seasonal vaccine. Cross-protection, such as reported in the JIID vaccine tests to date when Ampligen(r) (an experimental therapeutic) is added, is prima-facie evidence that conserved sequences may indeed be recognized with certain specific immunizing "cocktails". A further description of adjuvant technologies and regulatory considerations is discussed in the week of May 4th issue of Biocentury.
The number of swine flu confirmed cases in Japan has soared from four to 200 within days, forcing authorities to shut down schools. According to Japanese sources, the sudden rise in cases may prompt the World Health Organization to raise the pandemic alert level to the highest level of 6.
About Super Special Consortia for Innovative Technologies (Description
from CSTP's Mission Statement):
"Strategic Promotion of Innovative Technologies
Innovative Technologies
* Technologies of the world's top-level
* Technologies that would have a considerable ripple effect in the
economy
Deploy a technology development strategy for swiftly grow[ing] budding
innovative technologies into the driving force of society-wide
innovations.
Specify the potential of excellent innovative technologies and develop
them in a timely manner for creating innovations.
Provide the potential for growth by enabling restricting factors such
as a lack of resources and environmental factors etc. to be overcome
and overcome the competition that exists at a global level.
Realization of continuous economic growth and an affluent society."
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is a specialty pharma 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) and Oragens. Ampligen(r) and Oragens 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 issued 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 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 N Injection(r) do not imply that the product will ever be specifically approved commercially for these other treatment indications; similarly, the completion of the NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.