SOTIO Initiates VIABLE, a Global Phase III Clinical Trial for Prostate Cancer Immunotherapy Treatment with DCVAC/PCa
SOTIO, a biotechnology company owned by the PPF Group, today 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.
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.
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.
SOTIO Biotech B.V.
Strawinskylaan 933
1077XX Amsterdam
Netherlands
Strawinskylaan 933
1077XX Amsterdam
Netherlands
SOTIO Biotech a.s.
Českomoravská 2532/19b
190 00 Prague 9
Czech Republic
Českomoravská 2532/19b
190 00 Prague 9
Czech Republic
SOTIO Biotech AG
Lichtstrasse 35 - WSJ-210
4056 Basel
Switzerland
Lichtstrasse 35 - WSJ-210
4056 Basel
Switzerland
SOTIO Biotech Inc.
180 Canal St., Suite 300
Boston, MA 02114
USA
180 Canal St., Suite 300
Boston, MA 02114
USA
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