CEL-SCI Gets Minutes on Clinical Hold FDA Meeting

CEL-SCI Corp. has received the official FDA minutes from a 2/8 meeting that discussed a partial clinical hold placed 9/2016 on a Phase 3 head and neck cancer study with the company’s investigational drug Multikine (leukocyte interleukin, injection). “Pursuant to this partial clinical hold, patients currently receiving study treatments can continue to receive treatment at the discretion of their physicians and with their consent, and patients already enrolled in the study will continue to be followed; 928 patients are enrolled in this study,” the company says. Additionally, CEL-SCI says it is working on the following FDA-requested action items:

1) An updated investigator’s brochure

2) A list of major protocol deviations, which CEL-SCI believes will affect study results, and provide a plan to identify major protocol deviations across all patients enrolled in the Phase 3 protocol.