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SOTIO will launch Phase II clinical trials for ovarian cancer
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.
SOTIO receives orphan-drug designation for Ovarian Active Cellular Immunotherapy
SOTIO has received orphan-drug designation from the U.S. Food and Drug Administration (FDA) for the active cellular immunotherapy (ACI) DCVAC/OvCa.