Paris (France), Copenhagen (Denmark) – Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO), a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced that the company has received the 9th unanimous recommendation from the Data Safety Monitoring Board (DSMB), an independent European board of experts that monitors the safety of the Livatag® Phase III trial, “ReLive”, to continue the study without modification.
The nine consecutive positive DSMB recommendations reinforce the acceptable safety profile of Livatag®. The ReLive study is an ongoing international, randomized Phase III trial designed to evaluate the efficacy of intravenous (IV) administration of Livatag® in patients with advanced hepatocellular carcinoma (HCC) after failure or intolerance to sorafenib. The study plans to enroll a total of 400 patients across approximately 90 sites. To date, more than 90% of the patients have been randomized in the study. The DSMB reviews the safety data of the treated patients in the study, totaling more than 900 infusions of Livatag®.
“As we are approaching complete randomization in the ReLive study, we are, once again, encouraged by the DSMB’s positive recommendation which confirmed the acceptable safety profile of Livatag® as regards to unexpected safety events. Enrolment is well on track and we should reach the 400 patients in the coming weeks, which comforts us in our planning of preliminary data announcement mid-2017. Livatag®’s potential to address the unmet medical need for HCC patients combined with the drug’s favorable safety profile is a significant cornerstone in Onxeo’s mission to develop innovative medicines for patients, providing patients with new therapeutic options, and a significant catalyst for the company value,” said Judith Greciet, CEO of Onxeo.
As per study protocol, the DSMB meets twice a year since study initiation to review the safety data of the ReLive trial and subsequently issues recommendations on the conduct of the study.