CEL-SCI Corporation has received approval from the Medicines and Medical Device Agency of Serbia to begin enrollment of subjects in its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection).
Serbia is the 11th country from which approval to participate in the world's largest Phase III trial for the treatment of head and neck cancer has been obtained.
The clinical sites in Serbia are expected to become active in the next few weeks. Approximately 72 of the worldwide total of 880 patients for the study are expected to be enrolled in Serbia
Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved by regulatory agencies (e.g. FDA) for use following completion of CEL-SCI's clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body's natural ability to fight tumors.
"Immunotherapy has come to be recognized as the next great breakthrough in cancer therapeutics. Science Magazine named cancer immunotherapy the Breakthrough of the Year for 2013. The magazine suggests that clinical trials have cemented immunotherapy's potential in patients and swayed even the skeptics. Science Magazine also reports that oncologists say a corner has been turned and we won't be going back. CEL-SCI has been an early participant in the study of cancer immunotherapeutics and it's very exciting to see this class of cancer therapies acknowledged for its potential to transform the treatment of cancer," stated CEL-SCI CEO Geert Kersten. "We are pleased to advance our Phase III trial, as Serbia becomes the latest country to participate in this important immunotherapy trial."
The Multikine Phase III 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, 10% 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. CEL-SCI's Multikine investigational immunotherapy is intended to create an anti-tumor immune response to reduce local/regional tumor recurrence and thereby increase the survival rate of these patients.
