ORLANDO -- Hemispherx Biopharma, Inc. (NYSE American:HEB) announced the filing of a clinical study report on AMP-600, a Phase I/II trial of intranasal Ampligen® in combination with FluMist® influenza vaccine with the U.S. Food and Drug Administration. Hemispherx is a research and development and, consistent with its commercial and early access program approvals, an emerging commercial development company focused on unmet medical needs in immunology, with a special emphasis in immuno-oncology.
The two-stage randomized, double-blinded, placebo-controlled, clinical trial assessed the immunogenicity and safety of intranasal FluMist administered sequentially with intranasal Ampligen. The report indicates that there was no evidence of any increase in adverse effects related to higher dosage levels of Ampligen or to the continued administration of Ampligen during the second and third dual vaccinations. The intranasal use of Ampligen and FluMist was generally well-tolerated and generated antibodies against influenza subtypes not present in the seasonal vaccine.
In February 2018, the U.S. Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted in favor of renewing its recommendation for the use of FluMist Quadrivalent vaccine for the prevention of influenza during the 2018-2019 flu season.
Pre-clinical studies of Ampligen in combination with seasonal influenza vaccines indicate the intranasal combination could be highly effective in vivo against both seasonal and avian influenza A viruses (H5N1) and 3 H5N1 clades. H5N1 is proven to be highly lethal in humans and has the mutagenic potential for pandemic transmission. In both preclinical and clinical studies, the intranasal combination of seasonal vaccine and Ampligen was observed to generate cross reactive antibodies, which could extend or preserve vaccine efficacy as viruses mutate.