Benzinga | Jan 6, 2021 06:48AM EST

AIM ImmunoTech Announces First COVID-19-Induced Chronic Fatigue 'Long Hauler' Patient Dosed with Ampligen

OCALA, Fla., Jan. 06, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE: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 AIM's 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 Prevention's 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 world's 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 Ampligen's 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."