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AIM ImmunoTech announces planned trial of intranasal Ampligen in combination with FluMist against avian flu

AIM ImmunoTech has announced that it plans to move forward with a trial of intranasal Ampligen rintatolimod as an adjuvant to AstraZeneca’s FluMist intranasal flu vaccine for the prevention of avian flu. The company said that it plans to run the trial as a follow-up to a 2012 trial of Ampligen in conjunction with FluMist that was conducted at the University of Alabama-Birmingham.

According to AIM, the company is basing the decision to develop nasal Ampligen for avian flu based on results from the 2012 study that demonstrated a significantly greater immune response to FluMist when followed by an intranasal dose of Ampligen and the induction of cross-reactive secretory Immunoglobulin A against several strains of avian influenza, including H5N1. The company also cited mouse studies from the mid-2000’s that demonstrated significantly increased survival in mice treated with intranasal Ampligen when challenged with several H5N1 strains; data from non-human primate studies; and results from a Phase 1 clinical trial of nasal Ampligen.

AIM CEO Thomas K. Equels commented, “The avian flu has emerged as a serious and ever-growing public health threat. We believe there is the potential for an influenza vaccination program that provides broader coverage than the currently approved vaccination programs, with the added simplicity of being delivered intranasally. Specifically, there is already both pre-clinical and clinical data which demonstrates potential for synergy between our lead compound Ampligen to provide greater efficacy and potential epitope spreading and cross-reactivity for avian influenza when combined with AstraZeneca’s FluMist vaccine. Based on the UAB clinical data to date, we believe such a combination therapy could also be an effective barrier against avian flu infections.”

Read the AIM ImmunoTech press release

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published on February 11, 2025

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