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VIABLE Study to Proceed in US
The U.S. Food and Drug Administration (FDA) notified Sotio in April 2014 that its complete response to the July 2013 clinical hold on the VIABLE Study has been reviewed and that the FDA has determined that it is safe to proceed under the Investigational New Drug (IND) application.” VIABLE is a global Phase III clinical trial for prostate cancer immunotherapy treatment with DCVAC/PCa. FDA’s removal of the clinical hold represents a major achievement for SOTIO’s global and US development efforts. SOTIO’s aim is to enroll approximately 1,170 prostate cancer patients in the VIABLE study, including patients from Europe, Russia and the United States. Enrollment of the first European patient in VIABLE study is expected during first half of 2014.
PPF Group expands in the field of biotechnology and immunotherapy
PPF Group has acquired a minority stake in OriBase Pharma, a biotechnology company which specialises in the development of new therapies in oncology. The acquisition will strengthen PPF’s research and product portfolio, currently represented by SOTIO which is developing a next-generation Active Cellular Immunotherapy based on activated dendritic cells for the treatment of cancer and autoimmune diseases. Cooperation between OriBase Pharma and SOTIO will enable the effective sharing of research, expertise and clinical development capacities in the area of immunotherapy and targeted therapies.
SOTIO Receives VHP approval to start Phase III Clinical Trial
SOTIO a.s., Prague, announced today that it received from the EU Heads of Medicines Agencies (HMA) a positive decision on a substantial amendment to its Phase III VIABLE Clinical Trial of DCVAC/PCa – an active cellular immunotherapy for the treatment of prostate cancer. The HMA originally approved SOTIO’s submission for the VIABLE Phase III clinical trial in March 2013. This amendment was submitted by SOTIO as part of the European Voluntary Harmonisation Procedure (VHP), based on feedback received from US Food and Drug Administration (FDA). Amendment was developed to ensure unification of the protocol design for EU and US. SOTIO plans to start recruiting patients in the trial beginning in March 2014.