AIM ImmunoTech Submits Pre-IND Application to the FDA for Phase 2 Clinical Study of Ampligen as ...
OCALA, Fla., Sept. 08, 2021 (GLOBE NEWSWIRE) -- 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 a Phase 2 clinical study of Ampligen as a potential infusion therapy for Post-COVID-19 Cognitive Dysfunction (PCCD).
This will be a Phase 2, two-arm, randomized, double blind, placebo controlled, multicenter study 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, is managing the FDA submission and will manage the clinical trial.
“This preliminary IND filing is not only a major milestone for the company, but also an important step forward for those individuals suffering from the debilitating long-term effects of COVID-19, including PCCD,” said AIM CEO Thomas K. Equels. “We are highly encouraged by the outlook for this trial based on the safety data we have amassed around Ampligen, combined with initial data suggesting that Ampligen may improve cognitive function among patients with PCCD. We look forward to reporting additional near-term milestones, as we advance Ampligen as a potential COVID-19 therapy.”
Developing an effective therapy is critical for relieving the socioeconomical impact of PCCD and its medical burden on the U.S. and global populations. People suffering from PCCD — including young adults — can suffer severe difficulties in concentrating, serious memory problems and inability to live an active lifestyle, unable to work, and even unable to perform everyday tasks. Recent coverage of this troubling emerging condition includes:
Early data have indicated that patients with symptoms of PCCD being treated with Ampligen in the ongoing AMP-511 Early Access Program have reported improvements in ability to concentrate or focus. Based on early data and AIM’s research, the company recently filed a provisional patent application for Ampligen as both an intravenous and intranasal therapy for PCCD.
The company hopes to make additional announcements about developing Ampligen as a potential COVID-19 therapy in the near future.
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.
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.
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AIM ImmunoTech Inc