Global Clinical Trial Phase III – VIABLE
SOTIO is currently testing the safety and efficiency of DCVAC/PCa treatment in an extensive global multi-center Phase III clinical trial for prostate cancer immunotherapy called the VIABLE study which was launched in 2014.
The acronym VIABLE is derived from the description of this trial: actiVe ImmunotherApy using dendritic cell-Based treatment for Late stage prostatE cancer.
In May 2014 the first patient was enrolled into the study in Hungarian Army Medical Center (Magyar Honvédség Egészségügyi Központ), Department of Oncology. The VIABLE study plans to recruit patients through cooperation with medical centers in around 20 European countries and the United States. SOTIO’s aim is to enroll a total of 1,170 prostate cancer patients in the study.
Description of Phase III - VIABLE clinical trial:
Clinical Trial SP005 VIABLE (Eudra CT: 2012-002814-38: IND: 015255) is a randomized, double-blind, multi-center parallel-group Phase III study designed to assess the efficacy and safety of the DCVAC/PCa added to standard of care in comparison with placebo, in men with metastatic castration-resistant prostate cancer eligible for first line chemotherapy. For more information please visit www.viablestudy.com.