Results of a multicenter randomized clinical trial showed that CIK cell immunotherapy reduced HCC recurrence and mortality by approximately 37% and 79%; the relapse-free survival in the treatment group (115 cases) was 44 months, 1.5 times that of the control group. The article was published in Gastroenterology, a leading journal in the field of gastrointestinal diseases (impact factor 12). SEOUL, Korea, June 9, 2015 — Seoul National University Hospital (SNUH) today announced the publication of the study “Immuncell-LC” in Gastroenterology, a leading journal in the field of gastrointestinal diseases. The main results of the study “Immuncell-LC Until now, no adjuvant therapy has been shown to reduce the risk of cancer recurrence after complete elimination of hepatocellular carcinoma (HCC), but “Immuncell-LC” is the first proven adjuvant therapy in the world. The results show that adjuvant immunotherapy using CIK (cell-guided killer) activated cells harvested from HCC patients’ own blood has been shown to reduce recurrence and mortality rates by approximately 40% and 80%. A team of Professors Jung-Hwan Yoon and Jeong-Hoon Lee from the SNUH International Department of Medicine conducted a comparative analysis of the efficacy and safety of adjuvant therapy with CIK cells in 230 patients who had their malignancies eliminated by surgical resection, radiofrequency ablation, or percutaneous alcohol injection in their multicenter randomized clinical trial. The subjects were divided into two groups: a treatment group (115 patients treated with adjuvant therapy Immuncell-LC, 16 treatments over 60 weeks) and a control group (115 patients not treated with adjuvant therapy). The result was a relapse-free survival (survival without recurrent disease, the primary endpoint of the study) of 44 months in the treatment group compared with 30 months in the control group, i.e., approximately 1.5 times longer in the former group compared with the latter. Relapse rates were 37% lower in the treatment group compared to the control group, while mortality rates were 79% lower in the former compared to the latter. The recurrence rate of HCC in the treatment group was 28% at 2 years, compared with 46% in the control group at 2 years. The mortality rate in the treatment group was 4% at 4 years, compared with 15% in the control group at 4 years. However, the two groups did not show significant differences in the occurrence of serious adverse effects. Principal investigators Jung-Hwan Yoon, M.D., Ph.D., and Jeong-Hoon Lee, M.D., Ph.D., said, “Early detection of HCC is a trend because regular screening can be performed for patients with a high risk of chronic hepatitis B and C, but relapse is common even after complete cure. Even after resective treatment for HCC (e.g., surgical resection, radiofrequency ablation or percutaneous alcohol injection), the recurrence rate remains at 70 percent at 5 years. This recurrence rate is quite high compared to the recurrence rate of less than 10% for early gastric cancer.” After about 120 milliliters of blood is collected from patients, the samples are cultured for two to three weeks under specific Good Manufacturing Practice conditions. The immune cells, called “CIK-activated cells,” have a high proliferation capacity. Patients can eliminate trace amounts of remaining HCC cells in the liver with this immunologically active adjuvant. About 6.4 billion CIK-activated immune cells can be injected in a single shot. Principal investigators Jung-Hwan Yoon, M.D., Ph.D., and Jeong-Hoon Lee, M.D., Ph.D., in turn, said, “Numerous efforts have been made to reduce the recurrence rate of HCC, but so far no therapeutic agent has shown good efficacy in large-scale clinical trials. With this study, this immune cell therapy agent becomes a therapeutic option to reduce recurrence rates and prolong overall survival, demonstrating its efficacy for the first time worldwide.” Primary liver cancer is a common nasty tumor among Koreans. Liver cancer is the sixth most prevalent cancer in Korea (prevalence rate of 7.3%), while the number of cancer patients in Korea in 2012 was 224,117. However, the survival rate of liver cancer within 5 years is 30.1%, and liver cancer is one of the tumors with the worst prognosis. This means that many patients suffer from the disease. It is worth mentioning that liver cancer occurs mainly in people between the ages of 40 and 50, when they have the best financial capacity. This cancer causes the greatest socioeconomic damage. The overall survival of liver cancer patients is expected to be significantly longer due to the excellent efficacy of this immunocellular adjuvant therapy developed in Korea. The efficacy of the customized chemotherapy method using the patient’s own blood may have minor adverse effects such as immune rejection. immunocell-LC is manufactured and distributed by Green Cross Cell, a subsidiary of Green Cross Corporation (Korea).