AIM ImmunoTech
Announces Filing of Provisional Patent Application for Use of Ampligen
as Both an Intranasal and an IV Therapy for Post-COVID-19 Cognitive
Dysfunction (PCCD)
Patients
with symptoms of PCCD being treated with Ampligen in the ongoing
AMP-511 Early Access Program have reported consistent improvements in
cognitive function
OCALA, Fla., Aug. 25, 2021 (GLOBE NEWSWIRE) -- AIM
ImmunoTech Inc. (NYSE American: AIM) today provided an update on the
company’s efforts to develop its drug Ampligen as a potential intranasal
therapeutic for COVID-19, including the announcement of a new
provisional patent application for Ampligen as both an intranasal and an
intravenous therapy for what AIM describes as Post-COVID-19 Cognitive
Dysfunction (PCCD).
AIM has been working steadily to expand
its COVID-19 patent portfolio. In addition to the new provisional patent
application addressing compositions and methods for treating PCCD, in
February 2020 the company filed multiple COVID-19-related provisional patient applications,
which are now patent pending worldwide, for Ampligen as a COVID-19
therapy and as a vaccine adjuvant. Developing an effective therapy is
critical for relieving the socioeconomical impact of PCCD and its
medical burden on the population. The people suffering from PCCD,
including some young adults, are afflicted with severe difficulties in
concentrating, serious memory problems and inability to live an active
lifestyle, unable to work, and even unable to perform everyday tasks.
Early
data has demonstrated that patients with symptoms of PCCD being treated
with Ampligen in the ongoing AMP-511 Early Access Program (EAP) have
reported improvements in cognitive function, according to Charles Lapp,
MD, at Hunter-Hopkins Center in Charlotte, N.C.
“The results of
some individual symptoms are very dramatic,” said Lapp, the EAP’s lead
investigator. “The results clearly show a significant reduction of one
or more symptoms of PCCD in patients after the administration of
Ampligen.”
Also, as recently noted in the Wall Street Journal,
intranasal immunity to the SARS-Cov-2 virus may be a key to controlling
the spread of COVID-19, especially the more contagious and deadly Delta
variant, which can accumulate in nasal tissues even in individuals who
have been vaccinated with currently available vaccines. AIM’s leadership
and scientific experts reached a similar conclusion in the early days
of the COVID-19 outbreak, deciding then to make the development of
intranasal Ampligen a major R&D goal.
“There is a growing
and significant need for effective therapies to treat COVID-19, both in
the acute phase and its longer-term effects,” said AIM CEO Thomas K.
Equels. “We believe that Ampligen has the potential to activate the
body’s innate immune system to fight COVID-19 through its use as a
front-line, early-onset therapeutic — which includes potentially
reducing intranasal viral load, potentially curbing the spread of the
disease and lessening its severity. We believe Ampligen also can play a
role in treating Post-COVID-19 Cognitive Dysfunction. PCCD is one of the
most common and disabling immediate after effects of acute COVID-19
infection.”
AIM’s approach has been strategic and methodical:
In August 2020, AIM identified an effective in vitro model
using human tracheal, bronchial epithelial cells at The Institute for
Antiviral Research at Utah State University which showed that Ampligen
was able to decrease SARS-CoV-2 infectious viral yields by 90% at
clinically achievable intranasal Ampligen dosage levels.
In November 2020, AIM disclosed positive pre-clinical results
from a test by Japan’s National Institute of Infectious Diseases (NIID)
This pre-clinical work determined that Ampligen, when used as a vaccine
adjuvant, provided 100% survival in a pre-clinical rodent model of
SARS-CoV as a surrogate model of SARS-CoV-2, in contrast to the control
group, which demonstrated 100% mortality. The preclinical findings
suggested Ampligen was generally well-tolerated by the experimental
cohort.
In early 2021, AIM launched a Phase 1 intranasal safety
study of Ampligen, testing the safety, tolerability and biological
activity of Ampligen at increasing doses, in anticipation of testing its
potential as an intranasal therapy. A total of 40 healthy subjects
received either Ampligen or a placebo in the trial, with Ampligen given
at four escalating dosages across four cohorts, to a maximum level of
1,250 micrograms. In June 2021, AIM announced that there were no Severe Adverse Effects
observed in the study at any dosage level, thus establishing that
Ampligen was well-tolerated when administered intranasally in humans.
A June 2021 article in the medical journal Cancers
stated that Ampligen has the potential to reduce the severity of
COVID-19 by “activating the innate and the adaptive immune systems by
activating a cascade of actions in human pancreatic cancer cells.” The
study’s authors include Prof. C.H.J. van Eijck, MD, PhD, the lead
investigator for an Early Access Program at Erasmus Medical Center in
the Netherlands, where Ampligen is being used to treat patients with
late-stage pancreatic cancer.
In July 2021, AIM announced significant progress toward a Phase 2a Human Challenge Trial
to test the intranasal prophylactic effect of Ampligen in separate
Rhinovirus hRV and Influenza cohorts. The study is part of AIM’s work to
develop Ampligen as a potential therapy against SARS-CoV-2 and other
respiratory viruses. The trial is expected to commence in Q4 2021.
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 of 1995 (the “PSLRA”).
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. Among other things, for those statements, the
Company claims the protection of safe harbor for forward-looking
statements contained in the PSLRA. No assurances can be given as to
whether any studies will be successful or yield favorable data. Studies
and 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. Significant additional testing and
trials will be required to determine whether Ampligen will be effective
in the treatment of respiratory viruses, including SARS-CoV-2, as an
intranasal therapy or otherwise, and no assurance can be given that this
will be the case. There is the potential for delays in clinical trial
enrollment and reporting because of the COVID-19 medical emergency. We
do not undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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