New Sites Initiated for CEL-SCI’s Multikine Phase III Trial
CEL-SCI Corporation’s Taiwanese partner, Orient Europharma, has added two additional Taiwanese clinical centers 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 center is the China Medical University Hospital which is located in Taichung, Taiwan, and the second center 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.
”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,” said Geert Kersten, CEO of CEL-SCI.
The Multikine Phase III study is enrolling patients with advanced primary, not yet treated, head and neck cancer on 3 continents around the world. 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. 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 3 week period prior to standard of care treatment. Multikine injections are administered in the area around the tumor 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 tumor recurrence and thereby increase the survival of these patients.