AIM ImmunoTech Announces Positive Safety Data in First Cohort of Phase 1 Clinical Study Investigating Intranasal Administrati...
April 07 2021 - 9:15AM
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.
Contacts:
Crescendo Communications, LLCPhone:
212-671-1021Email: aim@crescendo-ir.com
AIM ImmunoTech IncPhone:
800-778-4042Email: IR@aimimmuno.com
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