AIM ImmunoTech
Announces Positive Safety Data in First Cohort of Phase 1 Clinical Study
Investigating Intranasal Administration of Ampligen as a Potential
Prophylaxis or Treatment for COVID-19 and Other Respiratory Viral
Diseases
OCALA, Fla., April 07, 2021 (GLOBE NEWSWIRE) -- AIM
ImmunoTech Inc. (NYSE American: AIM) today announced that it has
completed dosing of Cohort 1 in a Phase 1 clinical study on the safety
of AIM’s drug Ampligen as an intranasal therapy, reporting no serious
adverse events, and paving the way for escalation of the dose in Cohort
2. The trial is a critical step in the company’s ongoing efforts to
develop Ampligen as a potential prophylaxis or treatment for COVID-19
and other respiratory viral diseases.
The Centre for Human
Drug Research (CHDR), an independent institute located in Leiden in the
Netherlands, is conducting the clinical study AMP-COV-100 (CHDR2049),
titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to
Evaluate the Safety and Activity of Repeated Intranasal Administration
of Ampligen (Poly I:Poly C12U) in Healthy Subjects.” AIM is the sponsor
and is funding the clinical study.
The study protocol calls for
the enrollment of eight healthy subjects in each of four Cohorts to
receive Ampligen. In addition, two healthy subjects in each Cohort will
receive placebo, for a total of 40 healthy subjects. The subjects will
receive intranasal dosing every other day for 13 days, for a total of
seven doses each. This study will assess the safety, tolerability and
biological activity of repeated administration of Ampligen intranasally.
The protocol design is for subjects in Cohort 1 to receive 75 μg of
Ampligen or a matching placebo, Cohort 2 to receive 200 μg of Ampligen
or a matching placebo, Cohort 3 to receive 500 μg of Ampligen or a
matching placebo, and Cohort 4 to receive 1250 μg of Ampligen or a
matching placebo.
“AIM is pleased with the positive results in
this first cohort. This Phase 1 safety study is designed to test the
parameters of Ampligen’s intranasal tolerance before commencing a Phase 2
study. While the higher doses that we plan to test in this Phase 1
trial may or may not be well tolerated, we plan on moving quickly into
Phase 2 studies with the doses that have successfully passed these Phase
1 tests, such as the dose used in Cohort 1.” said AIM CEO Thomas K.
Equels.
AIM will continue to provide interim updates on the clinical trial.
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 cannot assure that the
CHDR study will be successful or yield favorable data 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
COVID-19 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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