Onxeo S.A. announced the completion of enrollment in ReLive, the international Phase III clinical trial evaluating Livatag® for the treatment of advanced hepatocellular carcinoma (HCC). The ReLive trial is evaluating the efficacy of intravenous (IV) administration of Livatag® (doxorubicin transdrug®) in patients with advanced HCC after failure or intolerance to sorafenib compared to the best standard of care chosen by the physician. In line with Onxeo's international development plan, the company has conducted this Phase III trial in 11 countries (Europe, USA, MENA). To date, 390 patients have been randomized, with about 260 patients in the Livatag® treatment group and 130 in the comparative group (best standard of care). The completion of patient randomization is an important milestone that confirms the expected timeline of issuing the preliminary efficacy outcomes of the study mid-2017. From a safety standpoint, nine DSMB reviews of the ReLive study have already been conducted over the course of the study. During these reviews, the experts did not identify unexpected adverse effects or signals and unanimously recommended each time the continuation of the trial without modification. These repeated positive recommendations - based on data from the administration of almost 1,000 Livatag® infusions - seem to indicate an adequate safety profile of the drug to date. These findings are important because they reflect the likelihood that this profile will be acceptable to both physicians and regulators.