VIENNA, Va.–(BUSINESS WIRE)–

CEL-SCI Corporation (NYSE MKT: CVM) today announced it has expanded its Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine* (Leukocyte Interleukin, Injection) in the U.S. with the addition of a new site in Scottsdale, Arizona. The 21st Century Oncology clinic in Scottsdale, along with the Arizona Cancer Research Alliance, has just joined the study and is actively screening patients for enrollment into the trial. The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer.

“Our clinical trial is now active in over 40 medical centers internationally and we are pleased to expand the number of sites in the U.S. More American patients now have the option of enrolling in this trial for Multikine, which aims to use the body’s own natural immune system to fight cancer. We look forward to working with 21st Century Oncology, and the Arizona Cancer Research Center to bring the potential of this innovative new method of treating cancer patients to Arizona,” stated CEL-SCI Chief Executive Officer Geert Kersten.

The Arizona Cancer Research Alliance (ACRA) is a community-based network for testing and validating medical interventions with the potential to diagnose, treat, ameliorate or cure cancer. The alliance is focused on creating infrastructure to support physicians who are believed to be responsible for over 80% of the care provided to patients with cancer.

21st Century Oncology is the largest global, physician-led provider of integrated cancer care services, operating 166 treatment centers, with 133 centers in 16 states in the U.S. and 33 centers in six Latin American countries.

The Principal Investigator for the Scottsdale site is Dr. Steven Finkelstein, whose clinical expertise includes radiation oncology, surgical oncology and clinical immunotherapy in the treatment of head and neck malignancies, prostate, breast, lung, and colorectal cancers. Dr. Finkelstein is a Scottsdale Board Certified Radiation Oncologist, National Director of the Translational Research Consortium, Adjunct Associate Professor at Translational Genomic Research Institute, and Executive Director of the Arizona Cancer Research Alliance.

21st Century Oncology’s Scottsdale clinic is the organization’s second clinic to join CEL-SCI’s trial as part of the CEL-SCI trial expansion. CEL-SCI recently announced 21st Century Oncology’s Greenville, North Carolina site had also joined the study.

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.