CEL-SCI Receives Regulatory Clearance to Expand Its Phase III Head and Neck Cancer Trial into Romania

CEL-SCI Corporation (NYSE MKT:

) today announced the Romanian Ministry of Health has cleared the Company to begin patient enrollment and conduct its Phase III head and neck cancer trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in Romania. “Romania, an EU-member state, is the eighteenth country to approve our Phase III study. In accordance with our clinical protocol, we plan to conduct the study in approximately 20 countries in addition to the U.S.,” stated CEL-SCI Chief Executive Officer Geert Kersten. About Multikine Phase III Study 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 improvement in the 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. About Multikine Multikine* (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries in addition to the U.S. In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the US Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.