On January 5, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that in 2015 it enrolled 340 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, JAN 5, 2016, View Source [SID:1234508669]). In the month of December it enrolled 33 patients. Total patient enrollment for the trial is now 668 as of December 31, 2015 in the world’s largest Phase 3 study in head and neck cancer.
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The enrollment of 340 patients in the study during 2015 represents a 75% increase over total patient enrollment of 195 in 2014. It also exceeds the total number of patients enrolled in the prior four years combined from 2011 through 2014.
Geert Kersten, CEL-SCI’s CEO, stated, "2015 has been a record breaking year for us in terms of patient enrollment, a key indicator of the progress we are achieving in our Phase 3 head and neck cancer trial. We believe that doctors would likely not be enrolling new patients in the study unless they believed that the Multikine treatment regimen was benefiting their patients. We further believe that Ergomed, the Clinical Research Organization (CRO) running the Phase 3 study since 2013, would not have invested an additional $2 million, for a total of $12 million, into the Phase 3 study if did not see a good chance of success."
Mr. Kersten added, "We also believe that this strong patient enrollment will be very helpful to us in CEL-SCI’s ongoing $50 million plus arbitration claim against the former CRO that used to run our Phase 3 study."
The current study goal is to enroll 880 patients through approximately 100 clinical centers in over 20 countries.
About the Multikine 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.
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. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF, which was added to the study in July 2015.
CEL-SCI has also entered into two additional co-development agreements for up to $3 million each 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.