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

Dec 24, 2020 22:00 JST

Source: AIM ImmunoTech Inc

OCALA, FL / ACCESSWIRE, Dec 24, 2020 - (ACN 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 solicitation of patient enrollment. Patients in the trial are treated 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.
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: 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 met the U.S. Centers for Disease Control and Prevention's criteria for chronic fatigue syndrome (See: JAMA Internal Medicine).

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, "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.

Contacts:
Crescendo Communications, LLC
Phone: 212-671-1021
Email: aim@crescendo-ir.com
AIM ImmunoTech Inc
Phone: 800-778-4042
Email: IR@aimimmuno.com

Cautionary Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

Source: AIM ImmunoTech Inc
Sectors: BioTech, Healthcare & Pharm