FDAnews
www.fdanews.com/articles/183139-fda-lifts-hold-on-clinical-trial-of-multikine
FDA_Logo_Black_2016.gif

FDA Lifts Hold on Clinical Trial of Multikine

August 17, 2017

The FDA lifted its partial hold on a Phase III clinical trial of a head and neck cancer immunotherapy being conducted by CEL-SCI Corp., of Virginia.

The trial, of CEL-SCI’s Multikine injection (leukocyte interleukin), had enrolled 928 patients. The company was unable to enroll any new patients since the hold was imposed in 2016.

CEL-SCI representatives met with FDA officials after the hold was imposed and responded with plans to provide an updated investigator’s brochure and procedures for compliance with clinical trials requirements, along with a list of major protocol deviations.

View today's stories