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Multikine

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. Enrollment was completed and 40 qualified patients were included in the study.

Study Site/Recruitment Status
Study Site Recruitment Status
China Medical University Hospital  Study completed
Taichung Veterans General Hospital Study completed
Hualien Tzu-Chi Hospital  Study completed
Chang Gung Memorial Hospital, Linkou Study completed
Chang Gung Memorial Hospital, Kaohsiun  Study completed
Shin Kong Wu Ho-Su Memorial Hospital  Study completed
Changhua Christian Hospital Study completed
National Cheng Kung University Hospital  Study completed
National Taiwan University Hospital  Study completed
2ccPA

2ccPA is a natural derivative of phospholipid (cyclic phosphatidic acid). Previous animal studies show that 2ccPA can inhibit inflammation and alleviate the pain caused by osteoarthritis.

 

The phase one clinical trial of 2ccPA is currently ongoing. The purpose of the trial is to evaluate the safety, tolerance, pharmacokinetics, and maximum tolerance dose (MTD) in administering a single dose of 2ccPA to patients with symptomatic osteoarthritis of the knee, and to collect scientific data as reference for subsequent trial designs and execution. Patient subjects are still being recruited.

 

Study Site/Recruitment Status
Study Site Recruitment Status
Tri-Service General Hospital Recruiting
Taipei Veterans General Hospital Recruiting
Shuang Ho Hospital Recruiting
National Cheng Kung University Hospital Recruiting
Chang Gung Memorial Hospital, Kaohsiung  Start in 2023
China Medical University Hospital Recruiting
Taichung Veterans General Hospital Recruiting
Chang Gung Memorial Hospital, Linko Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital Recruiting
Taipei Medical University Hospital Start in 2023
Taipei Tzu Chi Hospital Start in 2023