AIM ImmunoTech Announces Availability of the ME/CFS Clinical Trial of its Drug Ampligen for Enrollment to COVID-19 ‘Long Haulers’

Institutional Review Board Authorizes Public Notification for Potential Enrollment of Subjects

Dr. Charles Lapp

Dr. Charles Lapp, Hunter-Hopkins Center, Charlotte, N.C.

Dr. Daniel Peterson

Dr. Daniel Peterson, Sierra Internal Medicine, Incline Village, Nev.

OCALA, Fla., Dec. 24, 2020 (GLOBE NEWSWIRE) — AIM ImmunoTech Inc. (NYSE American: AIM) announced today 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. For more information, see AIM featured in The Wall Street Journal, “Long-Haul COVID Patients Put Hope in Experimental Drugs.”

Dr. Lapp states, “It is anticipated that COVID-19 will trigger a large number ‘long haulers’ suffering COVID induced brain impairment and disabling fatigue. I believe the investigational immune-modulating antiviral drug Ampligen might have a role to play as a future therapy. I believe the data to date suggests that early treatment will lead to better levels of efficacy.”

Dr. Peterson states: “A hypothesis-based re-analysis of CFS patients treated with Ampligen in a randomized-controlled study showed that CFS patients with shorter duration of CFS symptoms were more than twice as likely to respond to Ampligen than the group as a whole. We are cautiously optimistic that early Ampligen treatment of post-COVID-19 patients with Long Hauler chronic fatigue will have the potential to induce a clinically beneficial outcome. This addition to the study will also allow longitudinal follow-up of clinical disease, as well as contribute to the investigation of pathogenesis and prognosis.” (See: PLOS ONE).

AIM CEO Thomas K. Equels states: “While major global pharmaceutical companies have understandably focused their efforts on developing COVID-19 vaccines, AIM believes there is an equally essential need to help post-COVID-19 patients who, while having recovered from the acute infection, may be suffering from long-term and debilitating COVID-induced chronic fatigue symptoms such as brain fog and disabling and profound post-exertional malaise. We hope that the treatment of ‘Long-Hauler’ patients in our AMP-511 clinical trial can help us to quickly determine whether Ampligen has potential as an important therapy for this post-COVID-19 syndrome. If successful, this may change millions of lives for the better.”

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 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. Company personnel were involved in the PLOSONE article referenced above. 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, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com

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

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/34b80e21-269d-47dd-baf9-885e123d042c

https://www.globenewswire.com/NewsRoom/AttachmentNg/7d09de7a-05e3-4f9d-a77b-922fcd9496c3