Date: 2015-05-26
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Sotio (Czech Republic)
Product: DCVAC/PCa
Action
mechanism: immunotherapy product/cell therapy. DCVAC/PCa is an active cellular immunotherapy treatment for prostate cancer patients. DCVAC/PCa is produced individually for each patient; it uses a patient’s dendritic cells (that are part of the immune system), to induce an immune reaction against presented tumor antigens.
Disease: prostate cancer
Therapeutic area: Cancer - Oncology
Country: Belgium, Bulgaria, Croatia, the Czech Republic, France, Germany, Hungary, Italy, the Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Turkey, UK, USA
Trial
details: VIABLE is a randomized, double blind, multicenter, parallel-group, Phase III study to evaluate the efficacy and safety of DCVAC/PCa as an add-on therapy to 1st line standard of care chemotherapy in men with metastatic Castration Resistant Prostate Cancer (mCRPC), which is based on overall survival (OS) in mCRPC patients treated with DCVAC/PCa versus placebo with standard care chemotherapy. The VIABLE study will recruit patients through cooperation with medical centers in 20 countries: Belgium, Bulgaria, Croatia, the Czech Republic, France, Germany, Hungary, Italy, the Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Spain, Sweden, Turkey, the United Kingdom and the United States. (NCT02111577)
Latest
news: * On May 26, 2015, Sotio announced that it will present an abstract highlighting the design, methods and objectives of its VIABLE study, the global Phase III clinical trial of DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients, in the poster session at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago. Autologous dendritic cell vaccination (DCVAC/PCa) added to docetaxel chemotherapy in a double-blind, randomized Phase III trial (VIABLE) in men with advanced (mCRPC) prostate cancer (Genitourinary (Prostate) Cancer Session: S Hall A, Saturday, May 30, 1:15 PM to 4:45 PM, Poster Board #63b, Abstract No. TPS5070) * On November 19, 2014, Sotio, a biotechnology company owned by the PPF Group, announced that the first US patient has been enrolled in its VIABLE study, the global Phase III clinical trial for DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients. The first US patient was enrolled into this Phase III global study in Rockville, MD. Sotio is targeting to enroll around 250 US patients, collaborating with physicians from more than 80 US medical centers. Initial patients were also recently enrolled into the study in Italy, UK, the Netherlands and Slovakia. The VIABLE study plans to recruit patients through cooperation with medical centers in the United States, Canada and 25 European countries. Sotio’s aim is to enroll approximately 1,170 prostate cancer patients globally. The first patient was enrolled into the VIABLE study in Hungary in May 2014. * On May 22, 2014, Sotio announced that the first patient has enrolled in its VIABLE study, the global Phase III clinical trial for DCVAC/PCa, an active cellular immunotherapy treatment for prostate cancer patients. The first patient was enrolled in Hungarian Army Medical Center (Magyar Honvédség Egészségügyi Központ), Department of Oncology. The initiations of individual countries have already started and the first patients will be enrolled in the coming weeks. SOTIO’s aim is to enrol a total of about 1,170 prostate cancer patients in the study from Europe, Russia and the United States.
