CEL-SCI Corporation's Taiwanese partner, Orient Europharma, has added two additional Taiwanese clinical centres in CEL-SCI's phase III head and neck cancer clinical trial for Multikine (Leukocyte Interleukin, Injection), the company's flagship investigational immunotherapy. The first centre is the China Medical University Hospital which is located in Taichung, Taiwan, and the second centre is the Buddhist Tzu Chi General Hospital which is located in Hualian, Taiwan.
As part of its large phase III clinical trial with Multikine, CEL-SCI's partners Teva Pharmaceuticals and Orient Europharma are conducting the Multikine phase III clinical study in Israel and Taiwan respectively. Both partners have already enrolled patients in the study and are adding clinical sites to further accelerate the enrollment of patients.
Geert Kersten, CEO of CEL-SCI said, "Following the positive safety finding by the Independent Data and Safety Monitoring Board that supervises this phase III clinical trial last fall, we are now in the process of significantly expanding the study. All efforts are being made to enroll all 880 patients as quickly as possible."
The Multikine phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on three continents around the world. The objective of the study is to demonstrate a statistically significant 10 per cent 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. The universally accepted current standard of care for the patient population being enrolled in the CEL-SCI study is surgery plus radiation or surgery plus concurrent radiation and chemotherapy, dependent on the risk factors for recurrence found after surgery. Multikine treated patients receive 15 local injections of Multikine over a three week period prior to standard of care treatment. Multikine injections are administered in the area around the tumour and in the area of the adjacent lymph nodes since those two areas are where the tumor is most likely to recur. Multikine is intended to create an anti-tumor immune response to reduce local/ regional tumour recurrence and thereby increase the survival of these patients.
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 for use following completion of our clinical development program, Multikine would become an additional and different kind of therapy in the fight against cancer: one that employs our body's natural ability to fight tumours.
CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system.