US clinical site opens for expansion of CEL-SCI’s global phase III immunotherapy head and neck cancer trial


CEL-SCI Corporation announced its phase III head and neck cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, injection) has activated its first US clinical trial expansion site at 21st Century Oncology in Greenville, North Carolina, USA. The trial is already active in dozens of hospitals and clinical centres in 12 countries.

According to a press release, 21st Century Oncology is the largest global, physician-led provider of integrated cancer care services, operating 166 treatment centres, with 133 centres in 16 US states and 33 centres in six Latin American countries. The Greenville, North Carolina facility is led by Ron Allison, a board-certified radiation oncologist specialising in head and neck cancer. 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/visualisation and ultrasound distance measurement devices.

“Our goal is to have between 10 and 15 US clinical centres participating in our phase III trial. We should be there by this summer.” says CEL-SCI chief executive officer, Geert Kersten.

Multikine (Leukocyte Interleukin, injection) is an immunotherapeutic agent that is being tested in a randomised, 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 programme 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 tumours. CEL-SCI is aiming to complete enrolment 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 to 110 clinical centres in about 20 countries.