GlobeNewswire Inc | Jan 6, 2021 06:45AM EST

January 06, 2021

OCALA, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that the active AMP-511 Expanded Access Program (EAP) has dosed its first COVID-19 Long Hauler patient with the drug Ampligen (rintatolimod), marking a significant milestone in AIMs efforts to develop an effective therapeutic for people suffering from post-COVID-19 infection chronic fatigue-like symptoms. Additional patients are in the process of being enrolled. The Company also reported it will host an investor conference call on January 12, 2020 at 11AM ET to discuss the AMP-511 trial, believed to be the first clinical trial to treat a patient with COVID-19-induced chronic fatigue-like symptoms, as well as to provide an overall status update on the Company.

The Ampligen EAP protocol is authorized at any one time to enroll up to 100 active Chronic Fatigue Syndrome trial participants, 20 of whom may be Long Haulers. All study subjects will receive the same Ampligen treatments. The EAP is being conducted by investigators Charles Lapp, MD, at Hunter-Hopkins Center in Charlotte, N.C., and Daniel Peterson, MD, at Sierra Internal Medicine in Incline Village, Nevada.

AIM is committed to helping the untold number of people who are already dealing with the long-term effects of COVID-19 infection, said AIM CEO Thomas K. Equels. The development of an effective therapy for COVID-19-induced chronic fatigue is a critical unmet public health need. SARS-CoV-2 infection-induced chronic fatigue may affect millions in the aftermath of the pandemic. Although AMP-511 is not a controlled trial, patients in this AIM-sponsored study are monitored closely and it may be possible to report important observations as early as May.

Hunter-Hopkins Center is excited to have started Ampligen therapy for the first time on a Long Hauler with CFS-like symptoms, said Dr. Lapp. This is a historic moment. We believe that Long Haulers experience a post-viral fatigue syndrome similar to many persons with Chronic Fatigue Syndrome, and starting treatment early and aggressively should enhance the potential to improve their symptoms and outcomes.

AIM announced late last year that the Ampligen-involved myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) EAP would be expanded to include patients previously diagnosed with SARS-CoV-2 which causes the disease COVID-19 and whose persistence of symptoms has led to the group being dubbed Long Haulers. Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network). In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. In fact, approximately 27% of survivors in a JAMA Internal Medicine study met the U.S. Centers for Disease Control and Preventions criteria for chronic fatigue syndrome. Early treatment may be a key to successful therapy (See: PLOS ONE).

View a recent U.S. National Institutes of Health workshop on Post-Acute Sequelae of COVID-19.

Ampligen is approved in Argentina as the worlds first therapy for severe Chronic Fatigue Syndrome and is the only late-stage drug in the U.S. development pipeline for ME/CFS, said Equels. We are highly encouraged by the prospects for Ampligen as a potential therapeutic for this devastating illness, and believe that the AMP-511 clinical trial will help validate Ampligens potential role in combatting COVID-19-induced chronic fatigue.

For more information, see discussion of AIM in The Wall Street Journal, Long-Haul COVID Patients Put Hope in Experimental Drugs.

Conference Call

AIM CEO Thomas K. Equels will host a conference call at 11:00 AM Eastern Time Tuesday, January 12, 2020. The conference call will be available on the Companys website at https://aimimmuno.com/events-presentations/, or via telephone by dialing toll free 877-407-8031 for U.S. callers, or +1 201-689-8031 for international callers.

For those unable to participate at that time, a replay of the call will be archived on the Companys website or can be accessed by dialing 877-481-4010 for U.S. callers, or +1 919-882-2331 for international callers and entering the pass code 39447. The replay will be available for 90 days.

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. For example, no assurance can be given that the Ampligen (rintatolimod) EAP protocol described above will yield positive results and additional testing and trials will be required. 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. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. 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, LLCPhone: 212-671-1021Email:aim@crescendo-ir.com

AIM ImmunoTech IncPhone: 800-778-4042Email:IR@aimimmuno.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/e293adfc-822c-47d9-a917-9b6b233789d4