CEL-SCI Corporation (NYSE AMEX: CVM) announced that its Taiwanese partner Orient Europharma Co. Ltd. (“Orient Europharma”) today is presenting its development strategies for CEL-SCI's investigational cancer therapy Multikine ® (Leukocyte Interleukin, Injection)* in Taiwan, at the World Orphan Drug Congress in Seoul, Korea. Orient Europharma is a development partner of CEL-SCI participating in the investigational cancer therapy Multikine (Leukocyte Interleukin, Injection) Phase III Pivotal global study for head and neck cancer. The presentation, titled: “Developing orphan drugs in Asia: Successful collaborative effort between biotechs & policy makers” will be delivered by Yao Ting Lin, Head, Orient Europharma’s Head of Business Development Division and will include a case study of its strategy for developing Multikine (Leukocyte Interleukin, Injection) in Taiwan. Taiwan has a high concentration of reported head and neck cancer cases and is expected to provide a significant number of patients for the CEL-SCI’s Phase III trial.
Orient Europharma has completed the Site Initiation Visit at all seven clinical centers in Taiwan and expects to enroll patients in the Taiwanese clinical centers this month. Overall the Phase III clinical study is expected to enroll about 880 head and neck cancer patients in about 48 hospitals in 9 countries on 3 continents. CEL-SCI's partner Teva Pharmaceuticals is conducting part of the Phase III study in Israel.
Multikine (Leukocyte Interleukin, Injection)
Multikine (Leukocyte Interleukin, Injection) is an investigational immunotherapeutic agent consisting of a mixture of naturally occurring cytokines, including interleukins, interferons, chemokines and colony-stimulating factors, currently being developed for treatment of head and neck cancer. Multikine (Leukocyte Interleukin, Injection) has been cleared by the regulators in 9 countries around the world, including the U.S., for a global Phase III clinical trial in advanced primary (not yet treated) head and neck cancer patients. This trial is believed to be the largest head and neck cancer clinical study ever conducted. A detailed description of the study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&rank=1.It is also thought to be the first Phase III study in the world in which immunotherapy is given to cancer patients first, i.e., prior to their receiving the current conventional treatment for cancer, including surgery, radiation and/or chemotherapy. This is important because conventional therapy may weaken the immune system, and may compromise the benefits of immunotherapy. Because Multikine (Leukocyte Interleukin, Injection) is given before conventional cancer therapy when the immune system is likely to be more intact CEL-SCI believes the potential exists for it to be more successful in activating an anti-tumor immune response under these conditions.