AIM ImmunoTech Announces Positive Safety Data from the Third Cohort of Its Phase 1 Intranasal Clinical Trial

On May 26, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it has completed dosing of Cohort 3 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 (Press release, AIM ImmunoTech, MAY 26, 2021, View Source [SID1234580606]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This is consistent with results in the first two cohorts of the study and at escalating doses.The study protocol called 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, subjects in Cohort 2 received 200 μg of Ampligen and subjects in Cohort 3 received 500 μg. The study is already proceeding with Cohort 4, with subjects receiving 1250 μg.

The Centre for Human Drug Research (CHDR), an independent institute located in Leiden in the Netherlands, is conducting the Phase 1 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.