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2014.05.27 Clinical Results for DC Vaccine Vaccell® Announced in Journal of Ovarian Research

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 Journal of Ovarian Research (2014, 7:48). Vaccell® is our exclusive technology that can powerfully induce the most effective reaction for an immune system response to cancer. The paper explains the clinical effectiveness and prognosis factors of Vaccell® for treating recurrent ovarian cancer.

Ovarian cancer takes time to produce symptoms because the ovaries are located in the pelvis. In many cases, this cancer has already advanced to stage III or IV by the time it is discovered. The rate of complete remission is increasing with the standard approach of an anticancer drug therapy. However, the cancer comes back within two years for 55% of these individuals and within five years for 70%. Anticancer drug therapy is used again when the cancer reoccurs, but this time the average response rate is only 10% to 25%. This is why there is a need for a new way to treat recurrent ovarian cancer.

One main purpose of this research is verifying the safety and clinical effectiveness of Vaccell®, a DC vaccine that uses WT1 peptides and other cancer antigens, for treating recurrent ovarian cancer. WT1 peptide was developed by Professor Haruo Sugiyama of the Graduate School of Osaka University. Another purpose is to identify the factors that influence the survival time of ovarian cancer patients. To perform this research, retrospective analysis was performed for 56 ovarian cancer cases at the Selen Clinic Group (located in Tokyo and Nagoya), which is a contracted medical institution of tella. All 56 cases started with anticancer drug therapy. When a vaccine was administered, 48% of these cases received anticancer drug therapy using a platinum agent. The remainder were administered an anticancer drug with no platinum agent or no anticancer drugs at all.
Analysis revealed that there was an immunological response in 71% of the 17 cases that used the WT1 peptide developed by Professor Sugiyama. In all 56 cases, the median survival time was 30.4 months from the first diagnosis of recurrent ovarian cancer and 14.5 months from the first dose of the vaccine. Multivariate analysis using the Cox proportional hazards model was used for survival time determinants. Analysis showed that there are two independent factors that influence survival time. One is an albumin level of at least 4.0g/dL prior to the first dose of the vaccine. The other is a lactate dehydrogenase (LDH) level below 200 IU/L. The median survival time was 19.9 months for cases with an albumin level of at least 4.0g/dL and 11.6 months for lower albumin levels. The corresponding disease control ratios were 36% and 15%, respectively. This analysis shows that maintaining good nutrition when the vaccine is administered may be key to extending survival time by making possible an effective immune response to the cancer antigens.
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.

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