Onxeo S.A., a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, has completed enrollment in ReLive, the international Phase III clinical trial evaluating Livatag for the treatment of advanced hepatocellular carcinoma (HCC).
Pr. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Principal Investigator of the ReLive study said that all patients have now been enrolled in the Phase III trial of Livatag and the DSMB recommendations point towards an adequte safety profile.
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. The company has conducted this Phase III trial in 11 countries (Europe, USA, Middle-East & North Africa).
So far 390 patients have been randomized and preliminary results are expected in mid-2017.
“Completion of enrollment in ReLive marks a significant milestone for the HCC community. This is a major step forward in the development of Livatag as a new therapeutic option in a pathology for which there is a strong need for new treatment. It is also a major achievement for Onxeo, which demonstrates its ability to complete a large international Phase III trial and marks a major value creation catalyst, in line with the expected publication of preliminary results in mid-2017,” concludes Judith Greciet, Chief Executive Officer of Onxeo.