- About us
- Clinical trials
- News & Publications
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.
Phase II of Clinical Studies of SOTIO Ovarian Program Has Its First Patient
Last week was into the clinical trials of Phase II of the ovarian programme successfully enrolled the first patient. The patient was accepted into the SOV02 trials by doctors from the Ostrava University Hospital. According to information from cooperating Czech medical centres, further patients should be joining within the next few days. After obtaining all regulatory approvals, SOTIO expects to start enrolling patients also in Germany and Poland in early 2014.
SOTIO Supports Local Prostate Cancer Awareness Day in Boston
On Thursday, September 12th, Sotio will be joining forces with esteemed Massachusetts state legislators, patient advocacy groups, and local Boston athletes in an effort to urge legislators to recognize prostate cancer as a public health priority. Sponsored since 2009 by the AdMeTech Foundation, the event will also include discussions on recent advances in the diagnosis and treatment of prostate cancer and a measure to increase funding to the National Institute of Health for the advancement of early detection initiatives.