First U.S. Clinical Site Opens for CEL-SCI’s Global Phase III Immunotherapy Head and Neck Cancer Trial Expansion


VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT:CVM) today announced its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) has activated its first U.S. clinical trial expansion site at 21st Century Oncology in Greenville, North Carolina. The trial is already active in dozens of hospitals and clinical centers in 12 countries.

21st Century Oncology is the largest global, physician-led provider of integrated cancer care services, operating 166 treatment centers, with 133 centers in 16 U.S. states and 33 centers in six Latin American countries. The Greenville, North Carolina facility is led by Dr. Ron Allison, a board-certified radiation oncologist specializing in Head and Neck Cancer. Dr. Allison, who is serving as the Principal Investigator of CEL-SCI’s Phase III study at the site, has authored several books in the field of oncology and holds several patents addressing radiation isometer measurement devices/visualization and ultrasound distance measurement devices.

“Our goal is to have between 10 and 15 U.S. clinical centers participating in our Phase III trial. We should be there by this summer.” stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in a 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 100-110 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.

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