CEL-SCI Corporation has received approval to start patient enrollment in Thailand in its ongoing phase 3 trial with its investigational cancer immunotherapy Multikine (Leukocyte Interleukin, Injection) in patients with advanced primary (not yet treated) head and neck cancer.
Thailand is the 24th country to authorize CEL-SCI's phase 3 trial for patient enrollment.
"We have now completed enrollment of over 50 per cent of the anticipated 880 patients in our phase 3 trial and continue to expand the trial into more sites to increase the rate of enrollment. In the past month alone, we have added Spain and Italy as participating countries in our trial. We plan to have approximately 100 clinical centres around the world in about 25 countries screening and treating patients," stated CEL-SCI chief executive officer Geert Kersten.
As of May 31, 2015, 463 patients had been enrolled in the global phase 3 study.
The Multikine phase 3 study is enrolling patients with advanced primary squamous cell carcinoma of the head and neck. 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-label, randomized, controlled, global pivotal phase 3 clinical trial as a potential first-line (right after diagnosis, before surgery) treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to 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.
Multikine is also being tested in a Ppase 1 study under a Cooperative Research and Development Agreement (CRADA) with the US Naval Medical Centre, San Diego, as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. CEL-SCI has also entered into two co-development agreements with Ergomed Clinical Research Limited to further the development of 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.