Multikine, a novel immunotherapy drug for the head and neck cancer, is currently in a Phase III pivotal clinical study for US FDA approval. Participating countries include the United States, Taiwan, Canada, Poland, Hungary, Russia, Israel and India.
The study plans to recruit 880 patients as subjects worldwide. The study will be the first clinical trial to enhance patient's immunity and weaken the tumor activity before the standard of treatment (surgery plus radiotherapy or concurrent chemoradiotherapy). The study was designed to compare the efficacy of "immunotherapy before standard treatment plus standard of treatment" and "standard of treatment" in patients with late stage of primary oral squamous cell carcinoma or soft palate cancer.
In Taiwan, the study was presided by Professor Hao Sheng-Po, who is also the founder of the Asian Society of Head and Neck Oncology and the chief of the ENT Department at the Shin-Kong Memorial Hospital. The clinical study was conducted in 9 medical centers. 88 qualified patients are expected to be included in the study, which is approximately 10% of the target patient number.