AIM
ImmunoTech Files Provisional Patent Application for Ampligen as an
Early-Onset Intranasal Therapy that May Also Confer Enhanced Immunity to
a Wide Range of Respiratory Viruses
OCALA, Fla., Sept. 27, 2021 (GLOBE NEWSWIRE) -- AIM
ImmunoTech Inc. (NYSE American: AIM) today announced the filing of a
provisional patent application for Ampligen as a potential early-onset
intranasal therapy designed to enhance and expand infection-induced
immunity, epitope spreading, cross-reactivity and cross-protection in
patients exposed to a wide range of RNA respiratory viruses, such as
influenza, Rhinoviruses and SARS-CoV-2, which causes the disease
COVID-19.
The new filing concerns the early-stage
administration of Ampligen following active viral replication after a
respiratory virus has entered a person’s nasal passages. AIM believes
that Ampligen – which is thought to be a powerful immune system
modulator – can help the body respond to such an infection by first
activating the innate immune system to blunt viral replication, and
then, as a second important step, inducing an enhanced cross-protective
immune response or a broad-based immune response, both to the virus and
potential variants of the virus.
Applications for clinical
trial authorization, which the Company plans to file in the near future,
are expected to include intranasal therapeutic effect as a primary
endpoint, but also exploratory endpoints to gather data supporting the
Ampligen-enhanced immunity.
“We have designed upcoming
clinical trials with exploratory endpoints that we believe will provide
data supporting this novel concept and further validate Ampligen’s
potential as an early-onset intranasal therapy,” said AIM CEO Thomas K.
Equels. “When vaccines are not available, or where no vaccine has been
developed, this therapy would use the power of the virus against the
virus. From a public health perspective, this may be a critical new
concept, especially for future novel viral outbreaks where no vaccine
has been developed. This approach builds on the strong existing data
demonstrating Ampligen’s broad antiviral activity against a range of
respiratory viruses, combined with the encouraging results from our
recently completed Phase 1 clinical trial to assess the safety,
tolerability and biological activity of Ampligen as a potential
intranasal therapy, which determined that the highest-dosage and the
every other day frequency of administration of intranasal Ampligen was
generally well-tolerated.”
AIM’s COVID-19 patent portfolio also includes:
A
provisional patent application for Ampligen as both an intranasal and
an intravenous therapy for what AIM describes as Post-COVID-19 Cognitive
Dysfunction (PCCD).
Multiple provisional patient applications for Ampligen as a COVID-19 therapy and as an intranasal COVID-19 vaccine adjuvant.
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 assurance can be given as to when
the Company will submit the applications for clinical trial
authorization, whether the applications will be required to be revised
or whether they will be approved. Even if the applications are approved,
they are only the initial steps. 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. In
addition, no assurance can be given that the patent application
described above or subsequent patent applications claiming priority to
this application ultimately will be granted. 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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