AIM ImmunoTech Announces that the ME/CFS Clinical Trial of its Drug Ampligen is Open for Enrollment to COVID-19 'Long Haulers'

Institutional Review Board Authorizes Solicitation for Enrollment of Subjects

OCALA, FL / ACCESSWIRE / December 24, 2020 / AIM ImmunoTech Inc. (NYSE American: AIM) announced today that the post-COVID-19 "Long Hauler" portion of the active (EAP) protocol received approval from the Institutional Review Board (IRB) for a solicitation of patient enrollment. Patients in the trial are treated with AIM's flagship pipeline drug Ampligen.

AIM 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.

Long Haulers will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. Up to 20 of the 100 active trial participants can be Long Haulers. The EAP is being conducted by 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: ). 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 met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome (See: ).

Given the massive pandemic caused by SARS-CoV-2, a virus almost identical in reference to pathogenesis to the first SARS virus, and the emerging literature supporting that 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 where acute SARS-CoV-2 infection-induced classic chronic fatigue symptoms. For more information, see AIM featured in The Wall Street Journal, "."

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: ).

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, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. Results obtained in animal models do not necessarily predict results in humans. No assurance can be given as to whether current or planned immuno-oncology clinical trials will be successful or yield favorable data and the 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. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Some of the world's largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, no assurance can be given that the Company's actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive. The Company recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients 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. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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