OCALA, Fla., June 21, 2021 (GLOBE NEWSWIRE) -- AIM
ImmunoTech Inc. (NYSE American: AIM) today announced that all subjects
have completed treatment in the Company’s Phase 1 clinical study to
assess the safety, tolerability and biological activity of Ampligen as a
potential intranasal therapy. A final study report is expect in the
third quarter of 2021.
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 study reported no Severe Adverse Events at any
dosage level.
With these positive preliminary results in hand,
the Company is now moving forward with the initial planning and
negotiations for a follow-up Phase 2 study testing Ampligen as a
potential broad-spectrum respiratory virus prophylaxis. Unlike other
drugs tailored to combat specific diseases, Ampligen targets and
amplifies the natural immune system pathways that fight viruses, meaning
that Ampligen delivered via an intranasal device could be an effective
preventive therapy for people who may be exposed to, or have recently
been exposed to, a respiratory virus such as influenza, or even common
coronaviruses and rhinoviruses (like the common cold). This Phase 2
study will test this proposition in humans. A successful Phase 2 study
could also establish Ampligen as a potential prophlyaxis against future
viral variants and future novel respiratory viruses for which there are
no current therapies. Moreover, an Ampligen prophylaxis could
potentially benefit vulnerable populations who are at increased risk of
transmission due to their environments, such as hospital workers; people
on cruises, cargo or miltary ships; people on commercial airplanes; and
service personnel in close quarters on military installations.
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. The Company is in the preliminary
stages of planning a Phase 2 Study of Ampligen as a broad-spectrum
respiratory virus prophylaxis. No assurance can be given as to if or
when such study will occur, the cost of such study or whether it 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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