November 6, 2017
Source: Press Release, Prague
SOTIO, a biotechnology company owned by the PPF Group, today announced the enrollment of the last patient into the VIABLE study, a global Phase III clinical trial evaluating DCVAC/PCa in combination with docetaxel for patients with metastatic castration-resistant prostate cancer (mCRPC).
The VIABLE study (Eudra CT: 2012-002814-38: IND: 015255) 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 the first-line standard of care chemotherapy for patients with metastatic castration-resistant prostate cancer (mCRPC). The study is being conducted in around 200 clinical sites in 21 European countries and the United States. Since its launch in 2014, 1182 patients were randomized in the VIABLE study. Data on the overall survival of patients in this study are expected in 2020.
Ladislav Bartonicek, CEO of SOTIO, said: “The completion of the patient enrollment to the VIABLE study is an important milestone. It is a major step towards registration of our active cellular immunotherapy and making it available for routine clinical use. We are grateful to all our medical partners, the patients and their families for their ongoing support of this study. After finalization of treatment and follow-up period, we expect to finalize the primary analysis of the data in 2020.”
“This pivotal clinical trial is building on many years of scientific research at Charles University and University Hospital in Motol in Prague and intensive development efforts of SOTIO,” Radek Spisek, Chief Scientific Officer of SOTIO comments. “Completing the enrollment underlines the significant progress SOTIO has made in the assessment of the innovative, dendritic cell-based active cellular immunotherapy for late stage prostate cancer and other cancer indications. We believe that adding DCVAC/PCa to standard chemotherapy can prolong patients’ lives and slow down disease progression.”
DCVAC is an active cellular immunotherapy treatment which is produced individually for each patient using the patient’s own dendritic cells (that are part of the immune system), to induce an immune reaction against tumor antigens. SOTIO is developing three product candidates using the DCVAC platform to affect multiple different cancers in various stages of disease - DCVAC/PCa for patients with prostate cancer, DCVAC/OvCa for patients with ovarian cancer and DCVAC/LuCa for patients with lung cancer. DCVAC/PCa was the first SOTIO investigational medicinal product to enter clinical research.
The company is currently evaluating the safety and efficacy of DCVAC in multiple Phase I to Phase III clinical trials.