IM ImmunoTech announces availability of the ME/CFS clinical trial of Ampligen for enrollment to COVID-19 'Long Haulers'.

AIM ImmunoTech Inc. announced that the post-COVID-19 “Long Hauler” portion of the active AMP-511 Expanded Access Program (EAP) protocol received approval from the Institutional Review Board (IRB) for a public notification of potential patient enrollment. Eligible patients enrolled in the trial receive treatment with AIM’s flagship pipeline drug Ampligen. AIM announced in October that the myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) clinical trial received IRB approval to include patients previously diagnosed with SARS-CoV-2 – which causes the disease COVID-19 – but who now demonstrate post-acute infection chronic fatigue-like symptoms. These patients are commonly referred to as Long Haulers because of the persistence of their post-COVID-19 symptoms. Ampligen is AIM’s TLR3 agonist immune-system modulator. It 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. The Ampligen EAP protocol is authorized to enroll up to 100 active 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, Nev. Enrollment is an important milestone in AIM’s program to develop Ampligen as a therapy for the millions of people who medical experts predict will suffer from SARS-CoV-2-induced chronic fatigue, including many with brain fog. Nearly 70 million COVID-19 cases have been recorded during the ongoing global pandemic. 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. Given the massive pandemic caused by SARS-CoV-2, a virus with almost identical genetic sequence and similar in pathogenesis to the first SARS virus with persuasive emerging evidence supporting COVID-19’s SARS-CoV-2 induced chronic fatigue is following a similar pattern. The development of an effective therapy is a critical unmet public health need for patients with acute SARS-CoV-2 infection-induced classic chronic fatigue symptoms.