AIM ImmunoTech Inc (NYSEAMERICAN:AIM) announced Monday that data has been published detailing how its drug Ampligen could have a considerable impact on people living with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) when administered in the disease’s early stages.
The statistically significant findings were published in Plos One, a peer-reviewed open access scientific journal published by the Public Library of Science.
Ampligen substantially improved physical performance in a subset of ME/CFS patients, the company said, and an analysis of Exercise Treadmill Testing (ETT) data showed a subset of patients with at least a two-fold increased exercise response to the drug.
The study divided 208 subjects into two subsets based on symptom duration; 75 patients had symptoms for 2-8 years and 133 patients had symptoms lasting outside that range.
Researchers identified 2-8 years as the target subset for the data analysis in order 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, the company said. More than half of the target subset improved by at least 50%.
This exercise improvement was associated with additional measures of improved quality of life, including an ability to climb the equivalent of nearly 175 more vertical feet after 40 weeks compared to before Ampligen treatment was started.
An analysis indicates that there may be a relatively short disease duration window early in the course of the disease prior to 8 years in which ME/CFS patients may see a significant clinical response, the company said.
Ampligen as a treatment for ME/CFS has major implications for the coronavirus (COVID-19) pandemic, the company said.
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, and approximately 27% of survivors met the CDC criteria for chronic fatigue syndrome.
The company cited 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 having the flu.
Certain coronavirus patients, known as long haulers, have symptoms that last for months and could be uniquely positioned to benefit from Ampligen, the company said.
To that end, AIM won approval from the Institutional Review Board (IRB) on October 6 to expand its AMP-511 Early Access Program for ME/CFS patients to also include long haulers. The plan is 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.
The company filed a provisional patent application for the use of Ampligen for COVID-19-induced chronic fatigue back in June.
“More than 10% 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),” Charles Lapp of the Hunter-Hopkins Cancer Center said. “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.”
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