AIM ImmunoTech Announces Positive Safety Data in Second Cohort of Phase 1 Clinical Study Investigating Intranasal Administrat...
April 27 2021 - 7:15AM
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it
has completed dosing of Cohort 2 in a Phase 1 clinical study to
assess the safety, tolerability and biological activity of Ampligen
as an intranasal therapy, reporting no serious adverse events
(SAE). AIM also reported no SAEs in Cohort 1. The study will
proceed with enrollment into Cohort 3.
The clinical study is crucial for 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 sponsoring and funding the clinical study.
The study protocol calls for a total of 40 healthy
subjects to receive repeated administration of either Ampligen or a
placebo. Subjects in Cohort 1 received 75 μg of Ampligen, while
subjects in Cohort 2 received 200 μg of Ampligen. The dosage will
escalate to 500 μg in the next cohort, Cohort 3, with the highest
level of 1250 μg planned for Cohort 4.
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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