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February 08, 2017

Information on ReLive Trial Design and Role of its Data Safety and Monitoring Board

Paris (France), February 8, 2017 – 8.30 am CET – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, wishes to clarify information regarding the ReLive trial design and conduct and, in particular, the role of its Data Safety and Monitoring Board (DSMB).

ReLive is an international, randomized Phase III trial aiming at demonstrating the efficacy of Livatag® vs. best standard-of-care on survival in patients with advanced hepatocellular carcinoma (primary liver cancer) after failure or intolerance to sorafenib.

The DSMB of the ReLive trial is an independent committee of experts dedicated to safety review only, based on the analysis of adverse effects and causes of deaths in a blinded mode[1]. The protocol and the DSMB charter approved by regulators did not include interim analysis or futility analysis for survival.

Therefore, survival, the main criteria for efficacy, has not been analyzed so far and will become available only mid-2017. Therefore, conclusions from previous DSMBs can only point towards a reasonable safety profile with no unexpected adverse safety signal and do not make it possible to speculate on Livatag®’s efficacy profile.

The study was conducted in 11 countries (Europe, USA, Egypt, Turkey, and Libanon), starting in France first to enable a close monitoring of safety during the first year and then gradually extended to additional countries.

In January 2017, the Company has announced the completion of enrollment and randomization in the ReLive trial and confirmed the expected availaibility of preliminary efficacy results mid-2017.

[1] Reviewers do not know the treatment administed to the patient.