Seoul National University Hospital Announced Pivotal Study Results Published in Gastroenterology

SEOUL, South Korea, June 8, 2015 /PRNewswire/ -- Seoul National University Hospital (SNUH) today announced the publication of primary results from the study of 'Immuncell-LC' in Gastroenterology, the top journal in the field of gastrointestinal disease. Up to now, there has been no adjuvant therapy which was proven to reduce the risk of tumor recurrence after complete removal of hepatocellular carcinoma (HCC), and 'Immuncell-LC' is the firstly proven adjuvant therapy in the world. Results showed that adjuvant immunotherapy with activated cytokine-induced killer (CIK) cells, attained from the own blood of patients with HCC, was shown to reduce recurrence and mortality rates by approximately 40% and 80%.                                                

The team of professors Jung-Hwan Yoon and Jeong-Hoon Lee at the Department of Internal Medicine, the SNUH made comparative analysis of adjuvant therapy with CIK cells, with respect to drug efficacy and safety, for 230 patients with HCC after their malignant tumor had been extirpated by surgical resection, radiofrequency ablation or percutaneous ethanol injection in their multicenter randomized clinical trial. These subjects were divided into 2 groups: the treatment group (115 patients with adjuvant therapy, Immuncell-LC, administered a total of 16 times for 60 weeks) and the control (115 with no adjuv.ant therapy) group.

As a result, recurrence-free survival (survival duration without recurrence, the primary endpoint of the study) was 44 months for the treatment group while that of the control group was 30 months. This is approximately 1.5 fold increase for the treatment group. The recurrence rate of the treatment group was 37% lower than that of the control group while the mortality rate of the treatment group was 79% lower than that of the control group.

The 2-year HCC recurrence rate of the treatment group was 28% while that of the control group was 46%. The mortality rate within 4 years of the treatment group was 4% while that of the control group was 15%. However, there was no significant difference in occurrence of serious adverse reactions between these two groups.

"Early detection of HCC is the trend as regular surveillances are made for patients with risk factors such as chronic hepatitis B and C, but recurrences are quite common even after a complete cure," said lead investigators Jung-Hwan Yoon, M.D., Ph.D. and Jeong-Hoon Lee M.D., Ph.D. "5-year recurrence rate is 70% even after HCC extirpation treatment (such as surgical resection, radiofrequency ablation or percutaneous ethanol injection)." "This is a high figure compared with that of less than 10% recurrence rate of early gastric cancer."

After collecting approximately 120 mL of patient's own blood, the sample is cultivated under specific conditions of the Good Manufacturing Practice (certified central facilities) for 2-3 weeks. The immune cells, referred to as "activated cytokine-induced killer cells" vigorously proliferate. Administration of this immune-active adjuvant to patient leads to destruction of minute HCC cells remaining in the liver. One injectable is able to administer approximately 6.4 billion activated CIK immune cells.

"There have been much effort to decrease recurrences of HCC, but there has been no therapeutic agent that has demonstrated the efficacy in a large-scale clinical trial up until now," said lead investigators Jung-Hwan Yoon, M.D., Ph.D. and Jeong-Hoon Lee M.D., Ph.D. "Through this study, this therapeutic agent of immune cells has established itself as a treatment modality, which reduces recurrence and prolongs overall survival, proven for the first time in the world."

Primary liver cancer is a common malignancy among Koreans. The prevalence rate of liver cancer in Korea is the 6th frequently-occurring cancer (7.3%) among 224,117 Korean cancer patients in 2012. Nevertheless, the 5-year survival rate of liver cancer is 30.1%, which is one of tumors with the poorest prognosis. This means many patients suffer from it. In particular, liver cancer occurs largely in the age of 40s and 50s when they are most vigorous in economic activities. This is the cancer that inflicts largest socioeconomic losses.

Owing to the excellent treatment effect of adjuvant therapy of immune cells, developed in Korea, it is expected that patients with liver cancer can have largely extended overall survival.

The capability of customized treatment, by utilizing patient's own blood cells, may have little serious adverse reactions such as immune rejection. The manufacturer and distributor of Immuncell-LC is Green Cross Cell, subsidiary of Green Cross Corporation.

SOURCE Seoul National University Hospital