VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of June the Company enrolled 19 patients with advanced primary, not yet treated, head and neck cancer into its global pivotal Phase III head and neck cancer trial for its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). A total of 54 patients were enrolled over the past three months, with 21 enrolled in April, 14 in May, and 19 in June. This marks a 93% increase over the prior three month period when a total of 28 patients were enrolled, with 8 in January, 6 in February, and 14 in March. Since the beginning of 2014, the Company has enrolled a total of 82 patients. This compares with 10 patients enrolled in the first half of 2013.
“As a result of active patient recruitment ongoing in an increasing number of clinical centers around the world, we are seeing the kind of acceleration we expect in patient enrollment numbers. With the United Kingdom having recently cleared our study, we are well past the halfway mark for country approvals. We are looking forward to receiving approvals from multiple additional countries later this year before being fully approved in all participating countries,” stated CEL-SCI Chief Executive Officer Geert Kersten.
So far, a total of 218 patients have been enrolled in the study. The study is expected to complete enrollment of 880 patients by the end of 2015.
About Multikine Phase III Study
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer. 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.