CEL-SCI Corporation announced that in 2014 it enrolled close to 200 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal phase III head and neck cancer trial for its investigational immunotherapy Multikine (leukocyte interleukin, injection). This annual enrollment represents an eight-fold increase over enrollment of 24 patients in 2013, the year during which CEL-SCI dismissed its prior clinical research organization (CRO) and replaced it with new CROs, Aptiv and Ergomed. Twenty one (21) patients were enrolled in the study during the month of December.

“During 2014 we enrolled more patients than we did in several years when we worked with our prior CRO. As we continue to work with our new CROs, we expect strong continued growth in monthly and quarterly patient enrollment for the balance of 2015,” stated CEL-SCI chief executive officer Geert Kersten.

A total of 880 patients are expected to be enrolled through approximately 100 clinical centers in about 20 countries by the end of 2015 in the world’s largest phase III trial for head and neck cancer. 328 patients have been enrolled in the study by the end of December, 2014.

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.

Multikine (leukocyte interleukin, injection) is an investigational immunotherapeutic agent that is being tested in an open-lable, 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 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.

CEL-SCI’s work is focused on finding the best way to activate the immune system to fight cancer and infectious diseases.