announced today it has held the Investigator Meeting for the European clinical investigators participating in the ongoing Phase III clinical trial of CEL-SCI’s investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Inj.). The meeting had 108 participants from 56 clinical centers that are or will be participating in the Multikine Phase III clinical trial for head and neck cancer. These clinical centers come from 13 European countries. The Investigator Meeting for the clinical centers in the United States and Canada is scheduled for November 2013. A total of approximately 880 patients are expected to be enrolled in this international Phase III study.
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. About 6% of all cancers are head and neck cancer with an estimated 650,000 new cases globally and about 150,000 in the U.S. and Europe. The objective of the study is to demonstrate a statistically significant 10% improvement in overall survival of enrolled patients who are treated with the investigational therapy Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival of these patients.
Should Multikine treatment plus SOC prove to be successful in demonstrating a statistically significant overall survival advantage in the Phase III study, and following the FDA review of the totality of the Multikine development program, Multikine plus the current standard of care treatment, following an anticipated marketing approval from the FDA, could then become part of the new standard of care treatment in this indication. That would represent a multi billion dollar market. The U.S. Food and Drug Administration (FDA) has already granted orphan drug designation to Multikine in the treatment of advanced primary head and neck cancer.