CEL-SCI Corporation announced that it has received the official minutes from its February 8, 2017 meeting with the U.S. Food and Drug Administration (FDA) in regards to the partial clinical hold placed on the Phase 3 head and neck cancer study with CEL-SCI’s investigational drug Multikine (leukocyte interleukin, injection) on September 26, 2016.
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 purpose of the Type A (face-to-face) meeting with the FDA was to allow an open and frank discussion of the clinical hold issues raised by the FDA and to secure the FDA’s input and clarification on how to address the partial hold issues.
The Action Items for CEL-SCI to pursue per the minutes from the FDA are the following:
1) Provide an updated Investigator’s Brochure and current procedures for compliance with requirements under 21 CFR 312 Subpart D to address the partial clinical hold.
2) Provide 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.
CEL-SCI is working diligently on responding to all action items.
CEL-SCI is giving the FDA issues top priority. It is our belief that addressing the action items listed above will support a favorable decision by the FDA to lift the partial clinical hold. While we think that we have understood the action items, it is possible that we have not understood all issues involved. All of our work is subject to the FDA’s review of our submission upon its completion and may or may not result in the lifting of the partial clinical hold.
(Source: Business Wire)