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.
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