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Proposed study of Ampligen as a vaccine adjuvant to increase cross-reactivity to influenza strains
Paul Goepfert, MD, Director for the Alabama Vaccine Research Clinic
OCALA, Fla., Feb. 28, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that Paul Goepfert, MD, of the University of Alabama-Birmingham (“UAB”), has agreed to act as the Principal Investigator for the company’s planned clinical study in the combination of Ampligen and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza. Ampligen would serve as a vaccine adjuvant.
This will be a follow-up study to a previous clinical trial at UAB, which indicated that intranasal delivery of Ampligen after the intranasal delivery of the FluMist seasonal influenza vaccine not only increased the immune response to seasonal variants in the vaccine by greater than four-fold, but most importantly induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3.
Paul Goepfert, MD, Director for the Alabama Vaccine Research Clinic, stated: “I’m excited for the opportunity to follow-up on my previous work regarding the combination of Ampligen and FluMist, especially with the rising threat of avian influenza.”
AIM has engaged Amarex Clinical Research, its Clinical Research Organization, with the preparation of an Investigational New Drug application and the eventual management of the planned clinical study. A key next step will be to identify study funding through industry or governmental grants.
AIM CEO Thomas K. Equels states: “Our strong belief in the potential of a second Ampligen and FluMist study in humans stems directly from the pre-clinical and clinical work performed with Ampligen and multiple influenza variants, including in the original UAB study. We believe that the U.S. government — which has made the growing threat of avian influenza a top priority — should take a long and close look at this data when deciding how best to prepare for a potential epidemic. Rather than spend perhaps billions of dollars on the lengthy development of a new mRNA vaccine, the government should instead consider the combination of Ampligen and FluMist, which would be no more than $10 million in development costs and far quicker to develop, since it already has strong human and non-human primate data suggesting its potential preventive efficacy against avian influenza. AIM believes that the potential for a rapidly deployable vaccine that includes Ampligen is clear.”