Onxeo announces positive DSMB recommendation to continue Livatag® ReLive study in HCC

Paris (France), Copenhagen (Denmark),  Onxeo S.A. (Euronext Paris, Nasdaq Copenhagen: ONXEO), an innovative company specializing in the development of orphan oncology therapeutics, today announced that it has received a unanimous recommendation from the Data Safety Monitoring Board (DSMB), the independent European board of experts that monitors the safety of the Livatag® Phase III trial, “ReLive”, to continue the study without modification.

As per study protocol, the DSMB meets twice a year to review the safety data of the ReLive trial and subsequently issues recommendations on the conduct of the study.

The positive DSMB recommendation granted for the eighth time  further confirms the acceptable safety profile of Livatag®.

ReLive 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, primary liver cancer) after failure or intolerance to sorafenib. The study plans to enroll a total of 400 patients across approximately 90 sites. To date, more than 65% 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 600 infusions of Livatag®.

“This eigth positive recommendation from our independent board of experts once again confirms Livatag®’s safety profile, based on data collected from a growing number of patients. We remain very confident in the potential of this innovative product based on a novel nanoparticle formulation, allowing to overcome tumor resistance to traditional chemotherapy. It  could represent a significant breakthrough in the treatment of hepatocellular carcinoma, a very severe cancer with a high unmet medical need,” commented Judith Greciet, CEO of Onxeo.  

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