Stanford University Researcher and Hemispherx Biopharma Consultant Present New Integrative Immunotherapy Approach
Suggests That the Safety and Bioactivity of TLR3 Agonists May be Unique
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Press Release Source: Hemispherx Biopharma, Inc. On Tuesday March 23, 2010, 8:00 am
PHILADELPHIA, March 23, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE Amex:HEB) (the "Company"), announced today the publication of an editorial entitled "TLR3 agonists as immunotherapeutic agents," published in the March 15, 2010 edition of Immunotherapy (2010) 2(2), 137-140, co-authored by Jonathan S. Berek, MD, Chairman, Stanford University School of Medicine Department of Obstetrics and Gynecology, and Christopher F. Nicodemus, MD, Chairman and Chief Scientific Officer, Advanced Immune Therapeutics, Inc., and HEB Consultant. Drs. Berek and Nicodemus have collaborated for more than a decade seeking to identify novel strategies to mobilize immunity to treat cancer and have conducted and published numerous preclinical and clinical studies, most notably in the field of ovarian cancer. Their long standing research interests form the basis for an active collaboration with the Company to evaluate the potential for Ampligen(R) (rintatolimod, Poly I : Poly C12U) and TLR3 agonists as cancer immunotherapeutics.
The invited editorial highlights recent advances in the fundamental understanding of the toll like receptor pathways, notably TLR-3 and their potential as pharmaceutical targets to "mobilize immunity to eradicate microscopic and macroscopic malignancy," concluding that therapeutic improvements are now "within reach."
The authors propose that "overly robust immune responses" may be harmful and suggest that "TLR3 pathways have been distinguished from other, perhaps more toxic, TLR pathways...the safety and bioactivity of TLR-3 specific agonists can be anticipated to be unique amongst potential TLR stimulatory agents." In the editorial, Ampligen(R), an experimental therapeutic, is repeatedly cited for its unique profile amongst TLR3 stimulating agents and its potential to enhance immunity targeting infection and cancer.
Pre-clinical experimentation is not necessarily indicative of clinical outcomes and the clinical use of experimental therapeutics, including Ampligen(R), is subject to regulatory agency review and approval requirements.
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(R) (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen(R) and Alferon(R) LDO. Ampligen(R) 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(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) and Alferon(R) 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(R) do not imply that the product will ever be specifically approved commercially for these other treatment indications.
Contact:
Hemispherx Biopharma, Inc.
Company/Investor Contact:
Dianne Will
518-398-6222
ir@hemispherx.net
