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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 PLOS ONE, 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: jamanetwork.com/fullarticle/415378). 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: https://jamanetwork.com/fullarticle/2768351).
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: AIM ImmunoTech PR June 11,
2020).
"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: https://jamanetwork.com/fullarticle/2768351)
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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