PHILADELPHIA, Sept. 3, 2008 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (AMEX:HEB) today announced that the Company will present at the BioPharm America Conference to be held on September 9 to 10, 2008 at the Grand Hyatt, Atlanta, GA. The oral presentation, "TLRs: New Targets for Broad-Based Pharmaceutical Development," is scheduled for Wednesday, September 10 at 3:30PM.
NDA Status: Chronic Fatigue Syndrome Treatment
Currently, the only TLR3 ligand in a completed clinical development cycle is Hemispherx's experimental therapeutic, Ampligen(r) (Poly (I):Poly(C12U)), a synthetic double-stranded RNA (dsRNA) which has shown broad-spectrum antiviral, immunomodulatory, and anti-proliferative properties in various pre-clinical and clinical tests. The Company's NDA, pending with the FDA, for Ampligen(r) for the potential treatment of chronic fatigue syndrome (CFS), represents the first NDA accepted for FDA review for a potential TLR-based systemic therapy.
TLRs: Natural Triggers of Host Defenses
In the presentation, ten human TLRs as a rich target for pharmaceutical development for the treatment of a wide variety of human diseases, with special focus on TLR3 will be discussed. The TLRs are essential in the induction of innate immunity and are required for a vigorous adaptive immune response to antigens, and may now loom critically important in view of numerous cancer/HIV/AIDS vaccine trials which have just recently failed due to the absence of adequate stimulation of innate immune responses.
Vaccine Enhancement Strategies
Adverse inflammatory responses for certain TLR agonists such as TLR9 and TLR4 that use a common intracellular signaling pathway have been observed in humans, thus confounding their clinical development. The "intracellular signaling" pathway for TLR3, however, is unique among the human TLRs that increases its potential importance in vaccine immunoenhancement.
Special Programs in Pandemic Readiness
The company will overview multiple registration-directed clinical trials as well as the special programs designed to intercept potential pandemic threats. The Special Programs include Alferon-LDO, a new oral formulation of the Company's FDA approved biologic, Alferon N, designed to combat emerging epidemics especially in the Pacific Rim; and unique immunoenhancement of vaccines as a second ground breaking application.
Registration Directed Programs
Parallel registration-directed clinical and preclinical studies include various infectious diseases and cancer due to Ampligen's(r) activation of immature dendritic cells, a potentially critical step in the body's immune fighting potential. Ampligen(r) has been demonstrated recently to provide significant immune response to H5N1 highly pathogenic influenza virus (HPIV) in primate studies conducted at the Japanese National Institute of Infectious Diseases ("JIID"). In addition, an ongoing Phase II clinical trial in older patients (60-80 years), recently fully enrolled in Australia, is evaluating the efficacy of Ampligen(r) in boosting immune responses to seasonal influenza vaccines among elderly patients and potentially producing "cross-protection." Each year's strains of seasonal influenza(r) are responsible for significant deaths globally, especially in people of advanced age. Ampligen(r) is also being evaluated as an immune enhancer in the field of therapeutic cancer vaccines, including in combination with therapeutic antibodies, with a consortium of academic centers of excellence.
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(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 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 NDA filing process with Ampligen(r) does not imply that the product will ever be approved commercially.