CEL-SCI gets approval to start enrollment for Multikine Phase III study for head and neck cancer

Dec 5 2013

Further advancing one of the largest Phase III trials for head and neck cancer in the world, CEL-SCI Corporation (NYSE MKT:CVM) announced today that it has received approval from the Agency for Medicaments and Medical Devices of the government of Bosnia and Herzegovina to begin enrollment of subjects into the Phase III Head and Neck Cancer clinical trial of its investigational cancer immunotherapy treatment Multikine (Leukocyte Interleukin, Injection). Bosnia and Herzegovina is the 10^th country into which CEL-SCI has now expanded its global Phase III trial. This also marks the Company's milestone in receiving approval to commence accrual in one-half the number of countries in the currently planned expansion of the study. The trial is expected to expand into a total of approximately 100 clinical centers in 20 countries. CEL-SCI expects to enroll approximately 30 patients in Bosnia and Herzegovina through three clinical centers.

Multikine is the first immunotherapeutic agent being developed as a potential first-line treatment for advanced primary head and neck cancer. If it were to be approved by regulatory agencies (e.g. FDA) for use following completion of CEL-SCI's clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that aims to employ our body's natural ability to fight tumors.

CEL-SCI is currently accelerating enrollment in its Phase III clinical trial for Multikine by adding a large number of clinical centers. In addition to these centers, the trial also benefits from clinical centers in CEL-SCI's partners' territories, Teva Pharmaceuticals in Israel and Orient Europharma in Taiwan.

"We are pleased with the accelerating pace at which new clinical centers and countries, which will participate in our study, are being added. From this we expect to see a fast pick-up in the number of patients enrolled in the study. We are aiming to complete enrollments of subjects in the second half of 2015. CEL-SCI offers a potential first-line approach to cancer treatment that employs the body's own immune system, before the current standard of care, which includes surgery plus radiation therapy or surgery and combined radiochemotherapy, is used," stated CEL-SCI CEO Geert Kersten.

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, 10% improvement in overall survival of enrolled patients who are treated with Multikine plus Standard of Care (SOC) vs. subjects who are treated with SOC only. Multikine is intended to create an anti-tumor immune response to reduce local / regional tumor recurrence and thereby increase the survival rate of these patients.

SOURCE CEL-SCI Corporation