AIM ImmunoTech Announces Positive Progress on Requested FDA Meeting for Proposed Ampligen Clinical Trial in Post-COVID-19 Cognitive Dysfunction
OCALA, Fla., Sept. 21, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced positive progress with the company's meeting request to the U.S. Food and Drug Administration (FDA) concerning a Phase 2 clinical study of Ampligen as an infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD). The meeting request has been deemed sufficient for transfer to the FDA's Division of Neurology by the FDA's Covid Scientific Technical Triage Team.
"We are pleased with this next step - the referral to the FDA's Division of Neurology - as our focus is on the brain-related symptoms of Long COVID," said AIM CEO Thomas K. Equels.
The planned Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study is designed to evaluate the efficacy and safety of Ampligen in patients experiencing PCCD. Eighty subjects will be randomized 1:1 to receive twice weekly infusions of Ampligen or placebo for a period of 12 weeks. Amarex Clinical Research, an NSF International company, will manage the clinical trial.
Dr. Kazem Kazempour, Amarex Clinical Research CEO, added, "We requested the FDA meeting to consult on the regulatory strategy for this treatment as a central nervous system product. FDA alignment with the strategy illustrates a positive step forward in finding a treatment for PCCD. Moreover, it is both exciting and gratifying to be working on this product for AIM. This is a new and serious COVID-induced disease indication for which there is currently no treatment."
For additional information on the brain-related effects of Long COVID, go here:
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.
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 granting of the Company's meeting request concerning the use of Ampligen as a therapy for PCCD to the FDA's Division of Neurology is an initial step, and no assurance can be given that a meeting will ultimately lead to an approved trial. 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.