AIM ImmunoTech Inc (NYSEAMERICAN:AIM) (FRA:HXB2) has entered into a sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) clinical study on the safety of AIM’s drug Ampligen as an intranasal therapy.
In a statement Friday, the company said the study is a critical step in its ongoing efforts to develop Ampligen as a coronavirus (COVID-19) treatment.
CHDR, an independent institute located in Leiden in The Netherlands, will conduct and manage the proposed clinical study 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.”
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AIM said the current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and one placebo group -- for a total of 40 healthy subjects. They will receive intranasal dosing every other day for 13 days, for a total of seven doses each.
The company is funding the clinical study and is working to finalize the study protocol. It will announce new information as it becomes available.
AIM, based in Ocala, Florida, 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.
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