FDA Removes Clinical Hold On AIM ImmunoTech's Mid-Stage Ampligen Trial In Pancreatic Cancer

The FDA has lifted the clinical hold on AIM ImmunoTech Inc's AIM investigational new drug (IND) application for a Phase 2 study of Ampligen for locally advanced pancreatic cancer (AMP-270).
The AMP-270 clinical trial's primary objective compares the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma.
Secondary objectives include comparing safety and tolerability. The Company will enroll approximately 90 subjects in the study expected to commence before year-end.
Related: AIM ImmunoTech Recruits hVIVO For Ampligen Trial For Prophylaxis Use Against Respiratory Viruses.
Ampligen is AIM's dsRNA product candidate being developed for cancers, viral diseases, and immune system disorders.
Ampligen is also being used as a monotherapy to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.
Price Action: AIM shares are up 14.30% at $0.86 during the market session on the last check Wednesday.