BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology and to supportive care products, today announced that the International Independent Board of Experts’ Data and Safety Monitoring Board (DSMB), in charge of the safety profile of the ReLive Phase III trial, unanimously recommended continuing the study without modification for the third time since the trial’s initiation.
The DSMB meets every 6 months and/or after reaching 75 treated patients to evaluate the tolerance of Livatag® and to ensure patient safety. In continuance with its November 2012 and April 2013 recommendations, the DSMB unanimously confirmed its recommendation to continue the study, based on its positive assessment of all safety data of Livatag®.
ReLive is an international, randomized Phase III trial aiming at demonstrating the efficacy of Livatag® on survival in 400 patients with advanced Hepatocellular Carcinoma (primary liver cancer) after failure of intolerance to Sorafenib.
As of the end of September, about 20 centers are opened in France and enrollment is on track with the plan. The European extension of the trial is ongoing as planned with authorizations already obtained in 6 countries (Spain, Italy, Russia, Hungary, Austria and Belgium). The Company plans to expand the trial to the United States in 2014, enabling completion of recruitment in 2015 and data in 2016.
“The follow up of Livatag®’s safety is a major aspect of the ReLive study. The reaffirmed recommendations of the DSMB and its positive evaluation of Livatag®’s safety data are crucial as they strengthen an acceptable safety profile of the product”, comments Judith Greciet, CEO of BioAlliance Pharma. “Livatag® is a key drug for the Company with potential sales of several hundreds of millions and addressing patients for whom there is no other therapeutic alternative”.