09/28/2021 | Press release | Distributed by Public on 09/28/2021 07:20
OCALA, Fla., Sept. 28, 2021 - AIM ImmunoTech Inc. (NYSE American: AIM) today announced that is has submitted a Pre-Investigational New Drug application (Pre-IND) to the U.S. Food and Drug Administration (FDA) for two separate Phase 2 clinical studies to study the potential of Ampligen as both an infusion and an intranasal therapy for early-onset COVID-19, the disease caused by SARS-CoV-2.
The two clinical trials will be Phase 2, randomized, double-blind, placebo-controlled studies to evaluate the efficacy and safety of Ampligen as an:
In addition to studying efficacy and safety, the new Phase 2 protocols include exploratory endpoints that the company believes could support its recently filed provisional patent application.
AIM CEO Thomas K. Equels stated: "With Ampligen's recently established intranasal safety profile, and the preliminary results from these trials, we may be able to show that Ampligen not only has an early-onset therapeutic effect against a broad spectrum of respiratory viruses, but also may provide a boost to post-infection immunity that will confer cross-protection against viral variants. We believe the clearly defined exploratory endpoints for the upcoming trials will substantially validate the significant potential of Ampligen. Moreover, as the principal architect of AIM's developing portfolio of COVID-19-related inventions, I personally believe our most recent provisional patent application for Ampligen, as an early-onset intranasal therapy, stands out as an extremely important development in the progression of our patent portfolio."
AIM believes that it is critical to test the potential of Ampligen as both an intravenous and an intranasal therapy for early-onset COVID-19, as there is science to support the potential of both approaches.
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. No assurances can be given as to whether any studies will be successful or yield favorable data. Studies 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 respiratory viruses, including SARS-CoV-2, 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.
Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: [email protected]
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: [email protected]