AIM ImmunoTech Announces PLOS ONE’s Publication of New Data Analyses Showing Importance of Disease Duration on Ampligen’s Positive Role in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

OCALA, Fla., Nov. 02, 2020 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) announced today the publication of statistically significant data detailing how its drug Ampligen could have a considerable positive impact on people living with the debilitating illness myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) when administered in the early stages of the disease. The data were published in , a peer-reviewed open access scientific journal published by the Public Library of Science.

AIM researchers found that the TLR3 agonist Ampligen substantially improved physical performance in a subset of ME/CFS patients. Analysis of Exercise Treadmill Testing (ETT) data from its Phase III trial has identified a subset of patients with at least a two-fold increased exercise response to Ampligen.

Study Analysis

The ME/CFS population of 208 subjects was divided into two subsets based on symptom duration. The Target subset consisting of 75 patients with ME/CFS symptom duration of 2-8 years was compared to a Non-Target subset consisting of 133 patients with symptom duration outside of the 2-8-year range. Researchers identified 2-8 years as the preferred Target subset for the data analysis in an attempt to reduce possible cases of spontaneous remission after disease onset, while still including several years for ME/CFS symptoms to persist.

The placebo-adjusted percentage increase in ETT and the vertical rise in feet while exercising on the treadmill in the Target subset were both at least twice that seen for the combined population of 208 subjects. While no clinically significant ETT response was seen in the Non-Target subset, within the Target subset, 51.2% of the Ampligen-treated subjects improved their exercise duration by at least 25% (p=0.003, a statistically significant value). This magnitude of exercise improvement was associated with additional measures of improved quality of life, including an ability to ascend the equivalent of nearly 175 more vertical feet at Week 40 when compared to the baseline value before the Ampligen treatment was started. The analysis indicates that there may be a relatively short disease duration window early in the course of the disease (before eight years) in which ME/CFS patients may see a significant clinical response.

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 CDC criteria for chronic fatigue syndrome, which requires at least 6 months of symptoms (See: ). There is now increasing evidence that patients with COVID-19 — the disease caused by SARS-CoV-2 — can develop a similar, ME/CFS-like illness, which aligns with anecdotal accounts of ME/CFS symptoms commencing after flu-like syndromes (See: ). 

The findings in the PLOS ONE publication potentially carry special importance for survivors of COVID-19, many of whom report classic chronic fatigue-like symptoms long after recovering from the acute SARS-CoV-2 infection. These patients are commonly referred to as “Long Haulers” because of the persistence of these symptoms. They are also uniquely situated to potentially benefit from Ampligen as an early onset therapy for subjects who have recovered from acute COVID-19 only to come down with chronic fatigue-like symptoms.

AIM announced on October 6 the receipt of Institutional Review Board (IRB) approval to expand its AMP-511 Early Access Program for ME/CFS patients to also include Long Haulers in the clinical sites at Incline Village, Nev. at Lake Tahoe and Charlotte, N.C. The expansion is designed to test the hypothesis that if Ampligen is to have beneficial effects on Long Haulers, then it would likely need to be used earlier in the disease process rather than later. AIM filed a provisional patent application for the use of Ampligen for COVID-19-induced chronic fatigue in June of 2020 (See: ).

“More than 10 percent of persons who contract COVID-19 develop long term symptoms that are remarkably similar to persons with Chronic Fatigue Syndrome (also known as ME/CFS). So there may be thousands of individuals with CFS-like illness in the near future. Such ‘Long Haulers’ could prove to benefit from Ampligen therapy. Moreover, the recently released analyses published in PLOS ONE indicate that the potential benefit of Ampligen in patients with ME/CFS may depend on treatment earlier in the disease,” said Charles Lapp, MD, of the Hunter-Hopkins Center, PLLC. (See: )

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 (PSLRA) of 1995. 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. For example, the FDA could require changes to the IRB approved trial protocol amendment and testing will be required to determine whether or not Ampligen will assist in the treatment of COVID-19 induced CFS-like cases. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in 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. No assurance can be given as to whether current, planned or other clinical trials necessary to potential FDA approval 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. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. The study was designed and conducted by AIM.

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Source: AIM ImmunoTech Inc.

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