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2014.05.12 Clinical Results for DC Vaccine Vaccell® Announced in Cancer Immunology, Immunotherapy

A research paper concerning DC (dendritic cell) vaccine Vaccell® of tella, Inc. (Head office: Minato-ku, Tokyo; President and Representative Director: Yuichiro Yazaki) was published in the April 29, 2014 electronic version of the academic journal Cancer Immunology, Immunotherapy (CII). The paper explains the effectiveness and prognosis factors of Vaccell® for treating inoperable locally advanced pancreatic cancer.

Pancreatic cancer is very difficult to treat and usually has an extremely negative prognosis. Surgery is the only treatment that has any hope of stopping this cancer. However, surgery can be performed on only 5% to 25% of all people with pancreatic cancer. Normally, anticancer drugs are used to treat inoperable advanced pancreatic cancer. Gemcitabine hydrochloride and S-1 are the main drugs that are used. At Phase III clinical studies in Japan and Taiwan, the median survival time was 10.1 months when using these two anticancer drugs. Recently, the Folfirinox therapy has been approved. Folfirinox has produced a significant increase in survival time compared with the use of gemcitabine. However, Folfirinox is used very cautiously in only a few hospitals specializing in cancer treatment because of this drug’s comparatively strong side effects. Consequently, there is a need for a new pancreatic cancer treatment with fewer side effects because of the limited treatment options for treating inoperable advanced pancreatic cancer.

The objective of this research was to confirm the efficacy and safety of the DC vaccine Vaccell® at a number of facilities, using anticancer drugs WT1 peptides and MUC1 (cancer antigens) for treating inoperable advanced pancreatic cancer. Another purpose was to determine the factors associated with extending survival time. The report is based on the retrospective analysis of 255 pancreatic cancer cases at following facilities: Shinshu University Hospital (providing this therapy as an “advanced medical treatment”), Nagasaki University Hospital, Sapporo Hokuyu Hospital, and our contracted medical institutions of the Seren Clinic Group (Tokyo, Nagoya, Kobe, Fukuoka). In all cases, DC vaccine was administered with anticancer drugs. Furthermore, in about 95% of the cases, DC vaccine was administered with chemotherapy after individuals had undergone neoadjuvant chemotherapy (DC vaccine and chemotherapy were used together from the outset in 5% of the cases) and the analysis was performed for a comparatively uniform group of patients.
In 255 cases, the median survival times from the pancreatic cancer diagnosis date and from the first dose of DC vaccine were 16.5 months and 9.9 months, respectively. The Cox proportional hazards model was used for multivariate analysis for survival time factors. This analysis revealed that erythema reaction (defined as a diameter of at least 3cm) in the area where the DC vaccine was administered was an independent factor for extension of survival time. Furthermore, Pearson’s chi-squared test demonstrated that for erythema reaction of the area where DC vaccine was administered, (1) the occurrence of a fever after administering the vaccine, (2) an albumin level of ≧3.5g/dL prior to administration of the vaccine, and (3) a prognostic nutritional index (PNI) of ≧40 are subordinate factors. This analysis shows that maintaining good nutrition and paying attention to other factors are important for Vaccell®.

The most important observation regarding this analysis is that the delayed separation pattern in the Kaplan-Meier curve (survival curve) for erythema reaction in the area where the vaccine was administered. The delay is an increase in survival starting about 10 months after the vaccine is first administered. This delayed separation pattern is described as a typical pattern for the effectiveness of a cancer vaccine in Guidance for Industry-Clinical Considerations for Therapeutic Cancer Vaccines, which was issued in October 2011 by the U.S. Food and Drug Administration. At the very least, it should be suggested the effectiveness of the vaccine for the individuals who participated in this test by these results.

This research has demonstrated the safety of the DC vaccine Vaccell® using WT1 peptides and MUC1. The report also showed that this vaccine may contribute on extending the survival time of individuals with inoperable advanced pancreatic cancer. The results of this research therefore provide important data for receiving approval for Vaccell®, which is one of the central elements of tella’s strategy for growth.

tella will gather more scientific evidence about DC vaccine Vaccell® in order to develop and make available even better cell therapies.

This matter will have only a negligible effect on results of operations in fiscal 2014.