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Japanese Government Accelerates Hemispherx Biopharma's Ampligen(r) Research Programs for Influenza Protection
GlobeNewswire News ReleasesPublished: 04/27/09 11:18 AM EDTReleased By:
Hemispherx Biopharma, Inc.
NewsvineFlu Virus Mutations May Limit Tamiflu Usefulness
PHILADELPHIA, April 27, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced today that it had received notice of an Annual Report (April 2008- March 2009) prepared by a Director of the National Institute of Infectious Diseases (NIID) to the governing organization of the Japanese Ministry of Health (acronym, MHLW) reporting a series of successful preclinical studies in new pandemic vaccines which rely critically on Ampligen(r) (Poly I : Poly C12U) an experimental therapeutic for efficacy. The efficacy was demonstrated both within the airways themselves as well as systemically. As a result, the program is expected to be accelerated into human volunteers promptly under supervision of NIID staff. The project is officially titled: "Clinical Application of the Influenza Virus Vaccine in the Intranasal Dosage Form for Mucosal Administration."
Concurrently, the company's collaborative partner in Japan, Biken Corporation, reported to Hemispherx successful completion of a series of animal/preclinical tests on Ampligen(r), an experimental therapeutic, necessary to support a new product registration in Japan. Successful studies in animal models, including the monkey studies conducted to date under auspices of the Japanese NIID, do not necessarily predict human safety and efficacy of any investigational product including Ampligen(r).
The recent emergence of a new swine flu strain with high associated mortality in Mexico provides additional significance to the Japanese studies. The original studies by Dr. Hasegawa and his colleagues that provided the basis for the expanded preclinical trials demonstrated cross clade protection against H5N1 isolates following vaccination with a seasonal influenza vaccine (J Infect Dis.196:1313-1320, 2007).
A recent Centers for Disease Control (CDC) "Health Advisory for the 2008-2009 Influenza season" also noted that 98% of 50 HINI influenza isolates were resistant to oseltamivir (Tamiflu(r)) and recommended that influenza vaccination efforts continue.
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 Hemispherx Biopharma, Inc. -- Research & Development: Welcome to our Website.
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.
CONTACT: Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
[email protected]
CCG Investor Relations
Sean Collins, Sr. Partner
310-477-9800
GlobeNewswire News ReleasesPublished: 04/27/09 11:18 AM EDTReleased By:
Hemispherx Biopharma, Inc.
NewsvineFlu Virus Mutations May Limit Tamiflu Usefulness
PHILADELPHIA, April 27, 2009 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) announced today that it had received notice of an Annual Report (April 2008- March 2009) prepared by a Director of the National Institute of Infectious Diseases (NIID) to the governing organization of the Japanese Ministry of Health (acronym, MHLW) reporting a series of successful preclinical studies in new pandemic vaccines which rely critically on Ampligen(r) (Poly I : Poly C12U) an experimental therapeutic for efficacy. The efficacy was demonstrated both within the airways themselves as well as systemically. As a result, the program is expected to be accelerated into human volunteers promptly under supervision of NIID staff. The project is officially titled: "Clinical Application of the Influenza Virus Vaccine in the Intranasal Dosage Form for Mucosal Administration."
Concurrently, the company's collaborative partner in Japan, Biken Corporation, reported to Hemispherx successful completion of a series of animal/preclinical tests on Ampligen(r), an experimental therapeutic, necessary to support a new product registration in Japan. Successful studies in animal models, including the monkey studies conducted to date under auspices of the Japanese NIID, do not necessarily predict human safety and efficacy of any investigational product including Ampligen(r).
The recent emergence of a new swine flu strain with high associated mortality in Mexico provides additional significance to the Japanese studies. The original studies by Dr. Hasegawa and his colleagues that provided the basis for the expanded preclinical trials demonstrated cross clade protection against H5N1 isolates following vaccination with a seasonal influenza vaccine (J Infect Dis.196:1313-1320, 2007).
A recent Centers for Disease Control (CDC) "Health Advisory for the 2008-2009 Influenza season" also noted that 98% of 50 HINI influenza isolates were resistant to oseltamivir (Tamiflu(r)) and recommended that influenza vaccination efforts continue.
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 Hemispherx Biopharma, Inc. -- Research & Development: Welcome to our Website.
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.
CONTACT: Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
[email protected]
CCG Investor Relations
Sean Collins, Sr. Partner
310-477-9800