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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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July 23, 2015
08:36 EDTHEBHemispherx announces final approval of securities class action settlement
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July 15, 2015
08:35 EDTHEBHemispherx submits ODD application to EMA for Alferon N Injection
Hemispherx announces that they have submitted an application for orphan drug designation to the European Medicines Agency, or EMA, for Alferon N Injection, an experimental therapeutic, to treat Middle East Respiratory Syndrome, or MERS. The EMA as determined the application to be valid, and the Committee for Orphan Medicinal Products, or COMP, has initiated the official review process. It is anticipated that the COMP will give an opinion on the application within the next 90 days. There are significant benefits for achieving Orphan Designation, including eligibility for grants from EU and Member State programs. Designated orphan medicines are assessed for marketing authorization centrally in the European Union with reductions/waivers in the fees and costs of the overall regulatory process. The designation allows companies to make a single application to the European Medicines Agency, resulting in a single opinion and a single decision from the European Commission, valid in all EU Member States. Authorized orphan medications, once commercially approved, receive benefits including ten years of complete protection from market competition with similar medicines.

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