Mar 8, 2021

AIM ImmunoTech Announces First Healthy Subjects Dosed in Phase 1 Intranasal Ampligen Clinical Study

Marks important milestone towards development of Ampligen as a potential prophylaxis or treatment for COVID-19 and other respiratory viral diseases

OCALA, Fla., March 08, 2021 — AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM’s drug Ampligen as a potential intranasal therapy. AIM’s ‘s goal is to develop Ampligen as a potential intranasal prophylaxis or early-stage treatment for COVID-19 and other respiratory viral diseases.

Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the clinical study, titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.”

The current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and eight placebo subjects, for a total of 40 healthy subjects. The trial is designed to assess the safety, tolerability and biological activity of repeated administration of Ampligen intranasally. The subjects will receive intranasal dosing every other day for 13 days, for a total of seven doses each. AIM is funding the clinical study.

The prior in vitro modeling at The Institute for Antiviral Research at Utah State University demonstrated that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels.

Thomas K. Equels, CEO of AIM stated, “We greatly appreciate the tremendous efforts of the entire team at CHDR to help us initiate our Phase 1 study of Ampligen as a potential intranasal therapy. Our objective is to expedite the development of Ampligen as a potential prophylaxis or treatment for COVID-19. Prior results of in vitro modelling were promising, and we are highly encouraged by the potential of an intranasal prophylactic approach using Ampligen to prevent infection and spread of COVID-19. We look forward to providing further updates as this critical trial progresses.”

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. 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 disease caused by the SARS-CoV-2 virus.

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” 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. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.


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AIM ImmunoTech Inc
Phone: 800-778-4042

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