PHILADELPHIA, Oct. 27, 2008 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) said that its collaborator, Advanced Immune Therapeutics ("AIT") (Wellesley, MA), will present new data on Ampligen(r) (Poly I: Poly C12U), an experimental immunotherapeutic, at the iSBTc annual conference in San Diego, CA, Oct. 31, 2008. The mission of the International Society for Biological Therapy of Cancer (iSBTc) is to "facilitate exchange of the most cutting edge preclinical and clinical data on the use of biological therapies in cancer."
The paper entitled "Enhancing Immunogenicity of Therapeutic Vaccines in Immunotherapy of Ovarian Cancer" will be presented by Christopher Nicodemus, MD, FACP, the Chairman and CSO of AIT.
Within the last 12-18 months, numerous cancer vaccines -- all in the absence of an immunoenhancing TLR3 ligand -- have missed "primary clinical endpoints" in phase 3 studies including lung cancer (NSCLC), prostatic cancer, ovarian cancer, etc. The current AIT/Hemispherx study is aimed at identification of clinically practical approaches to enhance the relevant immune responses of these experimental vaccines. In considering possible adjuvants for clinical use, a specific TLR3 ligand was identified by AIT because of the large clinical experience (greater than 90,000 drug administrations) and unique mechanisms of action of Ampligen(r).
Specifically, Ampligen(r), an experimental immunotherapeutic, deploys exclusively an intracellular "signaling" pathway which is not redundant with any other available TLR ligands. The study will report the magnitude of T cell responses and the modulation of intracellular mediators, called "cytokines," which may underlie the robust immune response.
Overall, the conclusions suggest that Ampligen(r) is a novel experimental candidate for combinational clinical studies with both anticancer antibodies and anticancer vaccines. These studies are expected to be expanded with investigators at leading Universities.
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 90 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 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; similarly, the completion of the NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.