By Chris Wack
AIM ImmunoTech Inc. said it has been notified by the U.S. Food and Drug Administration that the agency has lifted a clinical hold on AIM's investigational new-drug application for a Phase 2 study of Ampligen as a therapy for locally advanced pancreatic cancer.
The lifting of the clinical hold means the company may proceed with the study.
The company said the AMP-270 clinical trial is planned to be a randomized study with the primary objective of comparing 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. AIM plans to enroll about 90 subjects across up to 30 centers in the U.S. and Europe, it said.
AIM shares were up 32% to 99 cents in premarket trading.
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(END) Dow Jones Newswires
March 16, 2022 07:49 ET (11:49 GMT)Copyright (c) 2022 Dow Jones & Company, Inc.