Hemispherx Biopharma, Inc. (AMEX: HEB) announced today that on Friday, October 20, Dr. Hideki Hasegawa, of Japan's National Institute of Infectious Diseases (JNIID), presented the results of his studies co-administering Hemispherx's double-stranded RNA (dsRNA) Ampligen® (polyI:polyC12U) experimental therapeutic with an H5N1 vaccine. Dr. Hasegawa's studies, presented at the Second International Conference on Influenza Vaccines for the World in Vienna, Austria, examined the protective efficacy of intranasal co-administration of inactivated whole-virion H5N1 vaccine with Ampligen® in mice and non-human primates.
Intranasal administration of a candidate influenza vaccine with Ampligen® resulted in secretion of IgA, also known as immunoglobulin A, the basis of mucosal immunity, and successfully protected subjects that were thereafter challenged with homologous A/Vietnam/1194/04(H5N1), heterologous A/HK/483/97(H5N1) and A/Indonesia/6/05(H5N1) viruses.
Dr. Hasegawa's presentation concluded: 1) that the intranasal administration of Ampligen® combined with H5N1 vaccine induced cross-protective mucosal immunity against heterologous H5N1 influenza virus infection in mice; 2) intranasal administration of Ampligen® combined with H5N1 vaccine provided protection in the macaque monkey, a non-human primate which has a complex immune system, similar to that of humans, from H5N1 infection; 3) Ampligen® is the only human-applicable dsRNA which has a well-documented safety profile in humans. Dr. Hasegawa and his colleagues at the JNIID intend to pursue human trials as soon as possible.
The FDA has recently announced an accelerated track to commercialization for an influenza vaccine based solely on documented immunological improvements in humans, even in the absence of any long-term clinical studies evidencing benefit in preventing flu.
Dr. William Carter, Chairman and CEO of Hemispherx Biopharma, Inc., stated the Company's intention to "replicate the Japanese studies using Ampligen® combined with H5N1 vaccines, pursuing a path that we hope will benefit from the FDA's new accelerated track to build defenses against an influenza threat."
The details of these studies and their results will be published in a peer-reviewed journal in coming months.
About Hemispherx Biopharma
Hemispherx Biopharma, based in Philadelphia, is a biopharmaceutical company engaged in the manufacture and clinical development of new drug entities for treatment of viral and immune-based disorders. Hemispherx Biopharma's flagship products include Alferon® and the experimental drugs Ampligen®, Alferon LDO and Oragens(TM). Alferon® is approved for a category of STD infection, and Ampligen® and Oragens(TM) represent experimental nucleic acids being developed for globally important diseases. Hemispherx's platform technology includes large and small agent components for potential treatment of various viral infections. Hemispherx has in excess of 100 patents comprising its core intellectual property estate, a fully commercialized product (Alferon® N) and GMP certified manufacturing facilities for its novel pharma 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®, 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® do not imply that the product will ever be specifically approved commercially for these other treatment indications.