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February 4, 2014
08:42 EDTHEBHemispherx summarizes clinical results of Phase I/II study of Ampligen
Hemispherx Biopharma presented a summary of the results of its Phase I/II study from the poster presentation entitled "Seasonal Influenza Vaccine and a TLR-3 Agonist, Rintatolimod --Ampligen, Given Intranasally Produced Cross-Reactive IgA Antibodies Against Pathogenic H5N1 Influenza HA" given at the American Society for Microbiology Biodefense Conference in Washington, DC on January 30. When FluMist, a seasonal influenza vaccine, was administered intranasally in conjunction with Ampligen, 92% of the subjects elaborated specific IgA antibodies against at least one of the homologous seasonal vaccine strains. Healthy volunteers also showed, surprisingly, enhanced IgA levels against emerging avian influenza viruses with the potential for causing a pandemic in humans. These antibodies were against one or more of 3 different strains of H5N1, H7N9, and H7N3. Two-thirds of these recipients showed a greater than or equal to 4-fold increase in specific IgA levels over baseline and some had measurable IgA levels one year after receiving FluMist in conjunction with Ampligen. A published challenge study in adults (aged 18-45) indicates that FluMistŪ alone generates ≥4 fold increase in serum HAI antibody response (a level thought to be protective) in 24% of recipients despite the fact that 85% of recipients were estimated to have been protected (Treanor, et al. (2000) Vaccine, 18:899). In Europe FluMistŪ is approved for individuals aged 2-17 compared to ages 2-49 in the US.
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January 26, 2015
08:34 EDTHEBHemispherx reports genetic changes in Ebola may impede potential treatments
Hemispherx Biopharma announced that in a new publication in the journal mBio, scientists at the U.S. Army Medical Research Institute of Infectious Disease, or USAMRIID, Harvard University, and Massachusetts Institute of Technology, or MIT, studied genetic changes in the Ebola virus, or EBOV, circulating in West Africa and concluded that genomic drift of the EBOV over time may be sufficient to block the action of otherwise potential therapies that target EBOV genetic sequences. The types of potential drugs at risk include monoclonal antibodies and small-interfering RNA which are scheduled to be evaluated during the current outbreak. The two platform drugs of Hemispherx, Alferon N and Ampligen, both experimental therapeutics in a setting of Ebola disease, have recently both demonstrated anti-EBOV activity and have mechanisms of action which are multifaceted by working through cellular "molecular cascades" rather than by targeting viral protein or genetic sequences whose specificity is vulnerable to mutational change as reported by the research consortium on January 20. Although none of the experimental drugs have been approved by the FDA, certain of the experimental therapeutics discussed in the USAMRIID/Harvard/MIT report, are being used to treat small numbers of patients under a World Health Organization, or WHO, emergency protocol. The potential impact of genomic drift on development of therapeutics for EBOV disease has already been realized for other pathogenic human virus, such as HIV and influenza. The large genetic and antigenic diversity seen in HIV has been a "major stumbling block" for development of preventative vaccines.

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