Hemispherx BioPharma (HEB)

[7nech]

Hemispherx 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 FluMist® 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 FluMist® is approved for individuals aged 2-17 compared to ages 2-49 in the US.