CEL-SCI Corp. announced that the French Agency for the Safety of Health Products has cleared the company to commence patient enrollment for its Phase 3 Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection) in France.
In the past three months CEL-SCI has also received governmental clearance to expand its trial into the United Kingdom, Austria, Sri Lanka and Turkey.
CEL-SCI’s Phase 3 trial is assessing the company’s investigational immunotherapeutic agent Multikine as a potential first-line treatment for advanced primary head and neck cancer. The Multikine Phase 3 study is enrolling patients with advanced primary, not yet treated, head and neck cancer. The objective of the study is to demonstrate a statistically significant improvement in overall survival of enrolled patients who are treated with the Multikine treatment regimen plus Standard of Care (SOC) vs. subjects who are treated with SOC only.
Date: July 30, 2014