AIM AIM ImmunoTech

AIM ImmunoTech Announces Publication of Final Clinical Study Results for AMP-518 Clinical Trial on Ampligen as a Therapeutic for Post-COVID Conditions

AIM ImmunoTech Announces Publication of Final Clinical Study Results for AMP-518 Clinical Trial on Ampligen as a Therapeutic for Post-COVID Conditions

OCALA, Fla., Jan. 23, 2025 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (“AIM” or the “Company”) today announced that the final Clinical Study Results for the “Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions” (“AMP-518”) was posted yesterday to ClinicalTrials.gov (See: ).

CEO Thomas K. Equels stated: “The results of AMP-518 support AIM’s belief in Ampligen as a potential therapeutic for people with the moderate-to-severe Post-COVID condition of fatigue. Our analysis of the final Clinical Study Results has helped us to identify a likely subject population that would experience the greatest benefit from Ampligen in AIM’s planned follow-up clinical trial. The AMP-518 data also comes on the heels of a new analysis of data that was generated through the National Institutes of Health RECOVER initiative, demonstrating a clear link between Long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. The report found that the prevalence of patients who met the 2015 Institute of Medicine ME/CFS clinical diagnostic criteria is five times higher than before the start of the COVID-19 pandemic. This means there has been a considerable increase in the number of patients that could be classified as having ME/CFS resulting from their COVID-19 infection. Hundreds of thousands of people have suffered from the painful and debilitating disorder of ME/CFS over the decades. With the growing reality of COVID-induced ME/CFS, it is now more important than ever that companies such as AIM and the public sector work together to develop meaningful therapies. We must take action to solve this unmet need, and not let another generation be lost to the ravages of ME/CFS.”

AIM had  positive topline results from its AMP-518 Phase 2 clinical trial. In further analyzing the results of AMP-518, AIM determined that, in this study, Ampligen-treated patients with Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo. The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks. A clear signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than 205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group who received the placebo. AIM therefore believes that any future trial design should focus on Ampligen’s therapeutic potential for subjects whose COVID-related fatigue or ME/CFS symptoms can be categorized as moderate or worse.

Read AIM’s January 22, 2025 press release: “”

Read “” in the Journal of General Internal Medicine.

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 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  and connect with the Company on , , and .

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 for Long COVID or ME/CFS. 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.



Investor Contact:

JTC Team, LLC
Jenene Thomas
908.824.0775
 
EN
23/01/2025

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on AIM ImmunoTech

 PRESS RELEASE

AIM ImmunoTech Announces Recent Presentation on the Potential of Priva...

AIM ImmunoTech Announces Recent Presentation on the Potential of Private-Public Partnerships for the Development of Oncology Therapies OCALA, Fla., July 02, 2025 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (“AIM” or the “Company”) today announced a presentation and discussion on immunotherapies involving AIM’s drug Ampligen at the recent , held June 17–20, 2025, across Silicon Valley, San Francisco and Stanford University. Pawel Kalinski, MD, PhD, a world-renowned research oncologist, presented on the drug and participated in a discussion session titled Revolution in Healthcare. Dr. Kalins...

 PRESS RELEASE

AIM ImmunoTech Announces NYSE American Notice of Noncompliance With Mi...

AIM ImmunoTech Announces NYSE American Notice of Noncompliance With Minimum Stockholders’ Equity Requirements NYSE American previously issued similar warning for same matter and issued the new notice because the deficiency remains as of March 31, 2025 AIM has until June 11, 2026 to regain compliance OCALA, Fla., June 20, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (“AIM” or the “Company”) (NYSE American: AIM) today announced the receipt of a warning notification (the “Letter”) from the NYSE American LLC (the “NYSE American”) stating that the Company is not in compliance with the minimu...

 PRESS RELEASE

AIM ImmunoTech Resumes Trading on NYSE American

AIM ImmunoTech Resumes Trading on NYSE American Company trading under the ticker “AIM” NYSE American effective at the start of trading today, Tuesday, June 17th OCALA, Fla., June 17, 2025 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (“AIM” or the “Company”) today announced that its common stock has resumed trading on the NYSE American under the symbol "AIM" and CUSIP 00901B303, effective at the start of trading today, June 17, 2025. 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 ...

 PRESS RELEASE

AIM ImmunoTech Granted U.S. Patent Covering Methods of Manufacturing T...

AIM ImmunoTech Granted U.S. Patent Covering Methods of Manufacturing Therapeutic dsRNA, Including Ampligen® Patent portfolio now includes protection for manufacture, methods and compositions Provides AIM with patent protection for manufacturing Ampligen until 2041 OCALA, Fla., June 12, 2025 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (OTC Pink: AIMID) (“AIM” or the “Company”) today announced the United States Patent and Trademark Office has granted U.S. patent No. 12312376, titled “Therapeutic Double Stranded RNA and Methods for Producing the Same.” The patent expires January 25, 2041. T...

 PRESS RELEASE

AIM ImmunoTech Announces NYSE American Removal of Trading Suspension

AIM ImmunoTech Announces NYSE American Removal of Trading Suspension Company expected to resume trading on the NYSE American on Tuesday, June 17, 2025 OCALA, Fla., June 12, 2025 (GLOBE NEWSWIRE) -- (OTC Pink: AIMID) (NYSE American: AIM) (“AIM” or the “Company”) today announced that the staff of NYSE Regulation has withdrawn its delisting determination and will be lifting the trading suspension of the Company's common stock on the NYSE American. The NYSE Regulation staff determined that the Company's common stock was now trading above the threshold of low selling price issues as further...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch