CEL-SCI Corp. has received the official minutes from its Type A (face-to-face) meeting with the U.S. Food and Drug Administration (FDA) concerning the partial clinical hold placed on a Phase 3 trial assessing Multikine (leukocyte interleukin, injection) in head and neck cancers.
A Type A meeting is required to help an otherwise stalled product development program proceed. The meeting between CEL-SCI and the FDA was held to allow an open and frank discussion of the clinical hold issues raised by the FDA and to get input from the agency on how CEL-SCI should address those issues.
The global Phase 3 trial (NCT01265849) was designed to assess the safety and effectiveness of Multikine plus standard-of-care therapy (surgery followed by radiotherapy or concurrent radiochemotherapy) vs. standard of care alone in patients with advanced primary squamous cell cancer of the head and neck (SCCHN).
The trial’s primary outcome was overall survival; secondary outcomes included progression-free survival, local regional control, and quality of life.
In September 2016, the FDA placed the partial hold on the trial, stopping CEL-SCI from recruiting new patients for the study. But the agency allowed the 928 patients already enrolled to continue to receive treatment if they wished.
CEL-SCI did not reveal why the FDA placed a hold on the trial.
To fulfill the FDA requirements for the hold to be lifted, CEL-SCI needs to:
1) Provide an updated Investigator’s Brochure and the procedures being adopted in the clinical trial as per the 21 CFR 312 Subpart D to address the partial clinical hold. (CFR stands for Code of Federal Regulations.)
2) Provide the FDA with a list of any major changes in the clinical trial protocol, and a plan to identify major alterations in the trial protocol across all patients enrolled.
“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,” a CEL-SCI press release stated. “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.”
Multikine, CEL-SCI‘s lead investigational therapy, is being developed for the potential treatment of head and neck cancer, peri-anal warts, and cervical dysplasia (a precancerous condition) in patients co-infected with both human immunodeficiency virus (HIV) and human papillomavirus (HPV). It is a defined mix of small proteins, called cytokines, known to induce strong immune responses.