AIM ImmunoTech Announces IRB Approval to Enroll COVID-19 ‘Long Haulers’ in the AMP-511 ME/CFS Clinical Trial of Ampligen
October 06 2020 - 9:00AM
AIM ImmunoTech Inc. (NYSE American: AIM) is pleased to announce
that it has received Institutional Review Board (IRB) approval for
the expansion of the AMP-511 Expanded Access Program (EAP) clinical
trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
(ME/CFS) to include patients previously diagnosed with SARS-CoV-2,
but who still demonstrate chronic fatigue-like symptoms. Patients
in the trial are treated with AIM’s flagship pipeline drug
Ampligen.
These patients — commonly referred to as
Post-COVID-19 Chronic Fatigue (PCCF) / “Long Haulers” because of
the persistence of their symptoms — will be able to receive
Ampligen treatments alongside the ME/CFS patients in the EAP. Up to
20 of the 100 active participants can be Long Haulers, according to
the new trial protocol amendment. AIM is currently preparing the
IRB-approved protocol for submission to the U.S. Food and Drug
Administration (“FDA”).
"It is anticipated that COVID-19 will trigger a large number of
CFS cases, providing an opportunity for the medical community to
learn more about the onset and pathogenesis of CFS,” according to
Charles Lapp, MD, a global expert in ME/CFS. “The investigational
immune-modulating antiviral drug Ampligen might have a role to play
in this scenario.”
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 (See:
https://jamanetwork.com/journals/jamainternalmedicine/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 (See:
https://jamanetwork.com/journals/jama/fullarticle/2768351). AIM CEO
Thomas K. Equels states, “With millions of U.S. cases of COVID-19
already on record we can expect a tidal wave of new U.S. cases of
COVID-19 sufferers who will exhibit serious chronic fatigue-like
symptoms. In addition, unpublished data from AIM indicates that
ME/CFS patients respond better to Ampligen the earlier they receive
the drug, so enrolling ‘Long Haulers’ earlier in their diagnosis
could potentially benefit these patients while also providing
valuable information for all ME/CFS patients.”
In June, AIM filed a provisional utility patent application for
Ampligen as a potential therapy for COVID-19-induced ME/CFS-like
illness (See:
https://aimimmuno.irpass.com/AIM-ImmunoTech-Files-Provisional-Patent-Application-for-the-Use-of-AmpligenR-as-a-Potential-Therapy-for-COVID-19-Induced-Chronic-Fatigue).
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
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. Human clinical
trials will be necessary to prove whether or not Ampligen will be
efficacious in humans. No assurance can be given as to whether
current or planned immuno-oncology clinical trials 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. In addition, initiation of planned
clinical trials may not occur secondary to many factors including
lack of regulatory approval(s) or lack of study drug. 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.
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/53029413-d7ab-421c-b47d-37c7fa39df48
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