PHILADELPHIA, July 12, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), announced that it has received a report, prepared by Hideki Hasegawa, M.D. Ph.D., Director, Laboratory of Infectious Disease Pathology, National Institute of Infectious Disease (NIID, formerly Japan's National Institute of Health), that summarizes the results of a three (3) year Japanese government funded program to develop and test a nasally delivered H5N1 (Avian Flu) vaccine which, when coupled with Ampligen®, an experimental therapeutic, provided a robust and long lasting immune response to the vaccine. The report, entitled "Research on Clinical Applications of Influenza Vaccines Formulated for Nasal Mucosal Delivery" was filed with Japan's Ministry of Health, Labor and Welfare (MHLW), which fully funded this work in non-human primates. All reports under grants from MHLW are submitted first to MHLW and then forwarded to the National Diet Library to be made available for public review. With permission, the following summary is provided:
Background
Quoting from Dr. Hasegawa's report, "Mucosal immunity, as represented by secretory IgA antibodies, has an important function in protection against infection by influenza viruses in the mucous membranes, which are the site of infection. Nasal vaccines administered to the mucous membranes are effective in stimulating the mucous membranes through vaccine inoculation. The purpose of this research is to study the relationship between the effect of a nasal vaccine for the highly pathogenic avian influenza (H5N1) and the dosage form, including adjuvant quantity, adhesion, etc. Finally, another purpose is to decide on a dosage form and administration method for putting a nasal influenza vaccine for nasal administration into practical use."
"We prepared inactivated full-particle vaccine as a trial vaccine, the double-stranded RNA formulation Ampligen [Synthetic double-stranded Poly I : Poly C12U (Ampligen®) was provided by Hemispherx Biopharma (Philadelphia, PA)] as an adjuvant, and carboxy vinyl polymer base (CVP) as a vaccine base, changing the content ratios."
"We used a vaccine base that heightens mucosal adhesion of the vaccine solution to investigate the antibody induction effect, and effect duration on cynomolgus monkeys, who have a nasal cavity width comparable to that of humans. The group in which adjuvant quantity was increased from 1:10 to 1:20 showed stronger antibody response, and the use of a formulation with even more mucosal adhesion showed a significantly higher antibody response in comparison with the lower-adhesion formulation. This shows that increasing adjuvant quantity and adhesion bolsters mucosal immune response."
Experimental Results
"Results showed that both the IgG antibody titer and the IgA antibody titer had the highest values two weeks after final immunization and were maintained at high values; in the group for which Ampligen twenty-fold was used, which showed the highest IgG antibody titer after half a year had passed, the value was maintained at at least 10 × 26 times, and that value was maintained even when a year had passed since vaccine inoculation. Moreover, the serum IgA antibody titer was at at least 10 × 23 times when half a year had passed, and that value was also maintained after one year had passed". (Emphasis added.)
The researchers concluded that their results could be applied to develop mucosally delivered vaccines for influenza virus prophylaxis focused on protection of the mucosal immune system against mutants.
A recent article in Lancet (vol. 375, pp 1108, March 2010) highlights that in England "around one child in every three was infected with 2009 pandemic H1N1 in the first wave of infection in regions with a high incidence, ten times more than estimated from clinical surveillance". (Emphasis added.) As of July, 2010, the World Health Organization (WHO) reports that as of 27 June (2010) worldwide more than 214 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 18,239 deaths.
Dr. William Carter, Chairman and CEO of Hemispherx, stated, "Dr. Hasegawa's work over the last three years brings into sharp focus Ampligen®'s (an experimental therapeutic) dose-response role in enhancing and extending both the IgA and IgG immune responses and to this vaccine against a pandemic H5N1 virus. The Lancet publication and WHO surveillance data highlights the continuing global threat of pandemic influenza and the need to develop novel more effective approaches to disease control."
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 large and small agent components for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of 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. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications.