AIM ImmunoTech Announces PLOS ONE’s Publication of New Data Analyses Showing Importance of Disease Duration on Ampligen’s...
November 02 2020 - 9:00AM
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.
Contacts:
Crescendo Communications, LLCPhone:
212-671-1021Email: aim@crescendo-ir.com
AIM ImmunoTech IncPhone:
800-778-4042Email: IR@aimimmuno.com
Source: AIM ImmunoTech
Inc.
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/1d4ca343-93dc-4e28-bae1-8f004af28bf0
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