The DSMB meets every 6 months and/or after the recruitment of 75 patients to evaluate the tolerance of Livatag®, and to ensure patient safety. On November 19, 2012, the DSMB unanimously recommended continuing the trial without modification. The DSMB renewed its recommendation at its recent meeting following the tolerance data review of Livatag®.
Parallel to this, a data review by the French National Agency of Medicine and Health Safety Products (ANSM) was planned after enrollment of the first 25 patients. Authorization was also granted from the ANSM in April 2013 to further continue the ReLive trial.
ReLive is an international, randomized Phase III trial aiming at demonstrating the efficacy of Livatag® on survival in 400 patients with Hepato Cellular Carcinoma after failure of intolerance to sorafenib. The trial started in France in June 2012 and is running in almost 20 French investigational sites. At this stage, about 40 patients have been enrolled, which is in line with the company’s expectations.
As planned, the study should be expanded to other European countries as well as the United States in the short to medium term.
“TheDSMB and ANSM recommendations are important milestones for the development of Livatag® in cancer with high medical needs. The recruitment is on target, which shows the marked interest of investigators for Livatag® as treatment for primary liver cancer,” declared Judith Greciet, Chief Executive Officer. “Livatag®, the leading product in our Orphan Oncology pipeline, is a strategic asset with a high growth potential for BioAlliance Pharma. Each milestone successfully completed is a step forward for our growth strategy and value creation for our shareholders.”