August 14, 2013
SOTIO is preparing to launch Phase II clinical trials at the end of September 2013 to assess the use of active cellular immunotherapy (DCVAC/OvCa treatment) combined with standard therapy in patients with epithelial ovarian cancer. SOTIO’s clinical trials will be conducted at medical centers in the Czech Republic, Germany and Poland. They will be focused on different groups of patients, based on the course of their disease and their reaction to standard therapy already used. Altogether 210 patients will be gradually enrolled in about 25 clinical centers. The initiation of the first of three clinical trials is scheduled for September 2013, the program will be completed in December 2017. Based on results of a tender, SOTIO has chosen Theorem Clinical Research as its strategic partner for organization of Phase II clinical trials in ovarian cancer program.
Description of individual Phase II clinical trials:
Clinical Trial SOV01 (Eudra CT: 2013-001322-26): a randomized, open-label, three-arm multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to standard chemotherapy (carboplatin and paclitaxel) in women with epithelial ovarian cancer.
Clinical Trial SOV02 (Eudra CT: 2013-001323-38): a randomized, open-label, parallel group, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to standard chemotherapy (carboplatin and gemcitabine) in women with relapsed platinum-sensitive epithelial ovarian cancer.
Clinical Trial SOV03 (Eudra CT: 2013-001325-24): a randomized, open-label, parallel group, multi-center Phase II clinical trial evaluating the effect of adding DCVAC/OvCa to chemotherapy in women with relapsed platinum-resistant epithelial ovarian cancer.
Countries the patients will be enrolled in:
Czech Republic, Germany, Poland