Rare Disease Report

Clinical Hold Lifted for Head and Neck Cancer Study

AUGUST 14, 2017
James Radke
The U.S. Food and Drug Administration (FDA) has removed a clinical hold on CEL-SCI’s Phase 3 clinical trial testing Multikine (Leukocyte Interleukin) in patients with head and neck cancer.
Head and neck cancers are a group of cancers that begin in the mouth, nose, throat, larynx, sinuses, or salivary glands. Most are squamous cell carcinomas and linked to alcohol or tobacco use. Treatment will depend on the location of the cancer as well as other factors (age, health, cancer stage).
Multikine is a mixture of 14 pro-inflammatory cytokines (interleukins, interferons, chomkines, and colony stimulating factors) developed by CEL-SCI.
In September, 2016, the FDA placed a partial clinical hold on CEL-SCI’s Phase 3 study, meaning that the 928 patients enrolled in the trial could continue to receive treatment but no additional patients could be enrolled.  
The hold was due to the FDA’s concern that the company had not responded to Independent Data Monitoring Committee (IDMC) recommendations in 2014 and 2016 to halt or halt recruitment of the trial. Furthermore, the FDA noted that the investigator brochure for the clinical trail was misleading, erroneous, and materially incomplete, and that the design of the clinical trial ‘is deficient in design to meet its stated objectives.
On February 8, 2017, the company met with FDA officials and based on that meeting, the FDA requested that the company provide:
1.     an updated Investigator's Brochure and current procedures for compliance with requirements under 21 CFR 312 Subpart D to address the partial clinical hold, and
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.
It is assumed that CEL-SCI provided those documents as the clinical hold has been lifted.
In the Phase 3 clinical trial, 928 newly-diagnosed head and neck cancer patients have enrolled in the study. The study's primary endpoint is a 10% increase in overall survival in patients receiving Multikine plus standard of care compared to patients receiving standard of care (surgery followed by radiotherapy or radio-chemotherapy).
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