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2013.08.06 Results of DC Vaccine Therapy Clinical Trials Announced in Journal of Gastrointestinal Surgery Study involves the effectiveness and prognosis factors of the DC vaccine therapy for treating unresectable advanced recurrent biliary tract cancer

A research paper concerning tella, Inc. (Head office: Chiyoda-ku, Tokyo; President and Representative Director: Yuichiro Yazaki; hereinafter “the Company”)’s DC (dendritic cell) vaccine therapy was published in the July 20, 2013 electronic version of the Journal of Gastrointestinal Surgery, the official publication of the U.S. Society for Surgery of the Alimentary Tract. The paper explains the effectiveness and prognosis factors of this therapy for treating unresectable advanced recurrent biliary tract cancer.

Bile produced in the liver pass through biliary tract to the duodenum. Surgery is used to treat operable biliary tract cancer and chemical therapy or radiation therapy is normally used when this cancer is inoperable. Only surgery can permanently eliminate this cancer. However, since this cancer is difficult to diagnose, it has reached an advanced in most individuals by the time the cancer is found. As a result, people with biliary tract cancer live for a median of less than one year after this cancer is diagnosed. For chemical therapy, the usual first choice for treatment is a combination of gemcitabine hydrochloride and platinum agent. In phase III clinical studies, the median survival time when using both of these anti-cancer drugs was reported to be 11.7 months. However, a new therapy needs to be developed because there is currently no effective second choice.
The objective of this research was to confirm the efficacy of the DC vaccine therapy, using WT1 peptides and MUC1 (both of which are cancer antigens) for treating unresectable advanced recurrent biliary tract cancer. Another purpose was to determine the factors associated with extending survival time. The report is based on the retrospectiveanalysis of 65 cases at four of the Company’s contracted medical institutions: Seren Clinic Nagoya (Nagoya City, Aichi), Seren Clinic Tokyo (Minato-ku, Tokyo), Seren Clinic Kobe (Kobe City, Hyogo), and Seren Clinic Fukuoka (Fukuoka City, Fukuoka). A RECIST evaluation was performed three months after the first dose of the vaccine. Of the 65 cases studied, there were 4 PR cases and 15 SD cases, resulting in a disease control ratio of 29%. Furthermore, the median survival time was 18.5 months. The Cox proportional hazards model was used to perform multivariate analysis of factors affecting the survival time. This process showed that there are four important independent factors: (1) use of the DC vaccine therapy with chemical therapy; (2) the albumin level (≧4.0g/dL) prior to administration of the DC vaccine therapy; (3) the level of C-reactive protein (<0.5mg/dL) before administration of the vaccine; and (4) the occurrence of a fever after administering the vaccine. This information shows that it is important to start chemical therapy in advance and to maintain sound nutrition for the effective use of the DC vaccine therapy.

This research has demonstrated the safety of the DC vaccine therapy using WT1 peptides and MUC1. The report also showed that this treatment may have an effect on extending the survival time of individuals with unresectable advanced recurrent biliary tract cancer. There have been several papers in recent years about immunotherapy that uses DC cells as a new way to treat cancer. However, these therapies are used as supplementary treatments after surgery. This research report was the first to examine the DC vaccine therapy as a way to treat unresectable advanced recurrent biliary tract cancer. Based on the results of this research, the Company will gather more scientific evidence about this therapy in order to develop and make available even better methods to treat cancer.

This matter will have only a negligible effect on results of operations in fiscal 2013.