January 9, 2013
SOTIO a.s. has selected Chiltern International Limited to be the Contract Research Organization (CRO) that carries out the European part of its phase III global clinical trial entitled VIABLE, which will include 1,170 prostate cancer patients from Europe and the U.S.
Under the agreement signed in December 2012, Chiltern will be responsible for providing full-service management of the VIABLE phase III clinical trial in Europe. It will be the contracting party for 126 treatment centers in 17 European countries where a total of 750 patients are expected to participate in the trial. Chiltern will also be responsible for processing the data obtained during this clinical evaluation.
Description of the clinical trial:
SP005 VIABLE (Eudra CT: 2012-002814-38): A randomized double-blind multicenter parallel-group phase III study designed to evaluate the efficacy and safety of the DCVAC/PCa drug in comparison with a placebo, in men indicated for chemotherapy of metastatic castration-resistant prostate cancer.
European countries where patients will be recruited for the VIABLE trial are:
Belgium, Bulgaria, Czech Republic, Croatia, France, Italy, Hungary, Germany, Netherlands, Poland, Portugal, Austria, Serbia, Spain, Sweden, Turkey, and United Kingdom. Romania, Russia and Slovakia may also be included following the removal of legislative barriers.