Full Press Release Details
OCALA, Fla., Feb. 28, 2025 — 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.”
Read more about the Ampligen-involved avian influenza pre-clinical and clinical work here .
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc., an Ocala, Florida-based company, is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The Company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system.
For more information, please visit aimimmuno.com and connect with the Company on X , LinkedIn , and Facebook .
Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy or vaccine adjuvant for any variant of influenza. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.