VIENNA, Va.–(BUSINESS WIRE)–
CEL-SCI Corporation (NYSE MKT: CVM) today announced that during the month of March the Company enrolled 14 patients with advanced primary, not yet treated, head and neck cancer into its global Phase III head and neck cancer trial. This marks the largest number of patients enrolled in the Company’s trial with its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in any month to date.
CEL-SCI’s trial, the largest Phase III head and neck cancer trial in the world, is now active in 12 countries through about 40 clinical sites. During the month of March five clinical centers were added to the study. By the end of 2015 the study is expected to complete enrollment of 880 patients through over 100 clinical centers. As the number of clinical centers increases, patient enrollment is scheduled to accelerate each month.
“In the balance of 2014 and 2015 we plan to add about 60 additional clinical centers to our study. With our new clinical research organizations, Ergomed and Aptiv Solutions, on board we are confident that we will meet our objective of completing patient enrollment by the end of 2015. We anticipate consistent month-over-month increases in the number of new patients enrolled,” commented CEL-SCI Chief Executive Officer Geert Kersten.
Multikine was well tolerated and used safely in CEL-SCI’s Phase II studies in head and neck cancer, as reported by the Phase II study investigators. In the trial, which formed the basis for the Phase III study, Multikine administration appeared to have caused, on average, the disappearance of about 50% of the cancer cells of treated patients. Based on pathology reports, 12% of patients had no remaining cancer cells after treatment with Multikine. These results were published in the Journal of Clinical Oncology.
