OCALA, Fla., Oct. 06, 2021 (GLOBE NEWSWIRE) -- AIM
ImmunoTech Inc. (NYSE American: AIM) today released detailed safety data
from a Phase 1 clinical study which supports the company’s belief that
its drug Ampligen has significant potential as an intranasal therapeutic
for COVID-19.
AIM previously announced that the study
to assess the safety, tolerability and biological activity of Ampligen
as a potential intranasal therapy was completed, and that a Safety
Report found the drug to be generally well tolerated and reported no
Severe Adverse Events. More details are now being published on both the AIM website
and on the website for the Centre for Human Drug Research (CHDR). A
total of 40 healthy subjects received either Ampligen or a placebo in
the trial, with the Ampligen given at four escalating dosages across
four cohorts, to a maximum level of 1,250 micrograms. The poster was
recently presented at the FIGON Conference in the Netherlands. Dosing was administered every other day (Table 1) for 7 doses.
The biological samples are being analyzed for non-safety-related immunological activity, with results expected in Q4 2021.
Based
on these positive safety results, AIM has moved forward in its efforts
to develop Ampligen as a potential intranasal treatment for COVID-19,
including:
A Phase 2a Human Challenge Trial (HCT) to
test Ampligen as a potential intranasal prophylactic using a human
rhinovirus (HRV-16, a common cold virus) and influenza A virus (H3N2),
which could help establish Ampligen as a potential prophylaxis against
future viral variants and future novel respiratory viruses for which
there are no current therapies, as well as mutations of known viruses
such as SARS-CoV-2, which causes COVID-19
A Pre-Investigational
New Drug application (Pre-IND) to the U.S. Food and Drug Administration
(FDA) for two separate Phase 2 clinical studies to study the potential
of Ampligen as both an intranasal and an infusion treatment for
early-onset COVID-19
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
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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