Hemispherx Files Positive Safety Report on Intranasal Use of Ampligen in Combination With FluMist Influenza Vaccine
Hemispherx Biopharma, Inc. recently 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 US 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.
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx’s flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen or Rintamod) and the FDA-approved drug Alferon N Injection. Based on results of published, peer reviewed pre-clinical studies and clinical trials, Hemispherx believe that Ampligen may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen already conducted by Hemispherx include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma, CFS, Hepatitis B and HIV. All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system. Commercialization of Ampligen® in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing) and we most likely will need additional funds to manufacture product at a sufficient level for a commercial launch. For more information, visit www.hemispherx.net.
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