BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces that the European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) held its first meeting on the ReLive Phase III trial and recommended continuing it without modification to evaluate the efficacy of Livatag® (doxorubicin Transdrug™) in primary liver cancer.
In order to ensure a regular safety monitoring of patients enrolled in ReLive, the organization of a Board of international experts was to meet every 6 months, and/or after inclusion of the first 25 patients, to review the safety data of patients included in the trial, and to recommend possible modifications of the protocol. This type of Board is usually organized in pivotal phase III clinical trials to assure patient safety and integrity of the trial.
Therefore, on November 19th, and 6 months after the study initiation, BioAlliance Pharma held its Board of Experts meeting which, based on the data review from the first patients included and treated, unanimously recommended continuing the trial without modification
This international, multicenter, randomized clinical trial aims at evaluating the efficacy of Livatag® on overall survival in nearly 400 patients suffering from Hepato Cellular Carcinoma, resistant or intolerant to sorafenib. Almost 20 French sites expert in hepatology are initiated. BioAlliance Pharma is planning to extend the study abroad in the short to medium term.
« This first recommendation is a very positive and encouraging sign for the safety profile evaluation of Livatag® and consequently for the pursuit of the study”, comments Judith Greciet, CEO of BioAlliance Pharma. “Livatag® is the leader of our “Orphan Oncology product” portfolio, core of the Company’s growth strategy. It represents a very strong asset for BioAlliance and ReLive is a key milestone that enhances its value”.