On September 1, 2015 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in the month of August it has enrolled 19 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary squamous cell carcinoma of the oral cavity/soft palate, a type of head and neck cancer (Press release, Cel-Sci, SEP 1, 2015, View Source [SID:1234507373]). Total patient enrollment is now 540 as of August 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.
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"A lower enrollment number in the month of August was expected since the majority of our clinical sites are in Europe and the month of August is known to be a primary vacation time in Europe. We expect enrollment in the fall to increase rapidly again with the goal of being completely enrolled by March of next year," stated CEL-SCI Chief Executive Officer Geert Kersten.
A total of 880 patients are expected to be enrolled, through approximately 100 clinical centers in over 20 countries.
About the Multikine Phase 3 Study
The Multikine Phase 3 study is enrolling just diagnosed, not yet treated 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. Standard of care for these patients consists of the surgical removal of the tumor and any locally involved lymph nodes, followed by radiotherapy or concurrent radiochemotherapy.
About Multikine
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 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 tumors.
Multikine is also being tested in a Phase 1 study under a Cooperative Research and Development Agreement ("CRADA") with the U.S. Naval Medical Center, San Diego, and at University of California, San Francisco (UCSF), 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.