PHILADELPHIA, Nov. 12, 2007 (PRIME NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) announced that its collaborative partner, Japan's National Institute of Infectious Diseases (JNIID), has published an article in the Institut Pasteur's publication Microbes and Infection 9 (2007) 1333-1340.
The article, titled "Intranasal immunization with H5N1 vaccine plus Poly I : Poly C12U, a Toll-like receptor agonist, protects mice against homologous and heterologous virus challenge," provides further support for the use of Ampligen(r), an experimental therapeutic, to strengthen the effects of avian flu vaccine, broaden the vaccine's protective effect to multiple ("heterologous") flu strains. This supports potentially extending existing supplies of avian flu vaccine by co-administering it with Ampligen(r).
In the words of the article, "intranasal administration of Ampligen(r) combined with H5N1 vaccine derived from a highly pathogenic influenza virus clinical isolate induced cross-protective mucosal immunity against heterologous H5N1 influenza virus infection. Intranasal vaccination co-administered with the TLR-3 agonist, Ampligen(r), appears to offer an effective strategy against an influenza pandemic, regardless of the strain of H5N1. The potential shortage of vaccine during a pandemic might also be addressed by preparing a stock of this vaccine in advance using the United States Food and Drug Administration 'animal rule' as a global model for regulatory approval by various governmental regulatory agencies."
This is the second article within the past month published in a peer-reviewed journal by Dr. Hasegawa of Japan's National Institute of Infectious Diseases on the vaccine-enhancing potential of Ampligen(r), an experimental therapeutic. The prior article, published in The Journal of Infectious Diseases (2007:196(1 November)), titled "Cross-Protection against H5N1 Influenza Virus Infection Is Afforded by Intranasal Inoculation with Seasonal Trivalent Inactivated Influenza Vaccine," concluded that intranasal inoculation with annual influenza vaccine plus Ampligen(r) may "overcome the problem of a limited supply of H5N1 virus vaccine by providing cross-protection mucosal immunity against H5N1 viruses with pandemic potential."
Dr. William A. Carter, Chairman and CEO of Hemispherx Biopharma, Inc, stated, "We at Hemispherx are thrilled and excited by the work of Dr. Hasegawa. We intend to continue our support of Dr. Hasegawa's studies and are actively pursuing partners to replicate his studies in the United States and Europe."
As reported in earlier press releases, Hemispherx is currently conducting a clinical trial co-administering Ampligen(r), an experimental therapeutic, with seasonal influenza vaccine in Australia.
On October 10, 2007 Hemispherx filed a New Drug Application (NDA) for Ampligen(r) as a primary therapy for Chronic Fatigue Syndrome (CFS). The Company plans additional filings with regulators in Europe in the coming months. The use of Ampligen(r) as both a CFS treatment and as an experimental immune enhancer with vaccines derives from the broad immune system stimulant effects of TLR3 activators such as Ampligen(r).
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced biopharmaceutical 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(r). 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 100 patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection(r)). The Company wholly owns and exclusively operates GMP certified manufacturing facilities 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.