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Hemispherx Shares Jump 13+% Following Release of Summarized Phase 1/2 Data on Flu Combo

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Hemispherx Biopharma, Inc. (NYSE: HEB) (the "Company" or "Hemispherx"), 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 (ASM) Biodefense Conference in Washington, DC on January 30, 2014.

When FluMist®, a seasonal influenza vaccine, was administered intranasally in conjunction with Ampligen® (an experimental therapeutic), 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 ≥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.

Dr. William Carter, CEO at Hemispherx, indicated that compared to systemic doses of Ampligen® used in other clinical studies, the amount of intranasal Ampligen® used in this study was as low as one eight thousandth (1/8,000) of the dose. In response to a question about safety, Dr. David Strayer, Medical Director at Hemispherx, indicated that there were no serious adverse events reported during the study and over 80% of the adverse events reported were mild.

The breath of immune response suggests that other groups, particularly vulnerable to influenza and unprotected by FluMist® alone, might benefit from an appropriate addition of an adjuvant.

Posted-In: News FDA


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