Paris (France), May 23, 2017 – 6.00 pm CEST – 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, today announced that the company has received the 10th unanimous recommendation from the Data Safety Monitoring Board (DSMB), to continue without modification the Phase III study of Livatag®, ReLive, in patients still undergoing treatment. The DSMB is an independent European board of experts that monitors the blind tolerability data from the study.
ReLive is an ongoing international, randomized Phase III trial designed to evaluate the efficacy of Livatag® in patients with advanced hepatocellular carcinoma (HCC) after failure or intolerance to sorafenib.
The Relive study protocol involved the recruitment of approximately 400 patients, divided into three arms: two Livatag® treatment arms at 20 and 30 mg /m2 every 4 weeks intravenously for 6 hours, until progression or intolerance, and a comparative arm of patients receiving the best available treatment chosen by their physicians. All patients under the protocol have been randomized since the end of January 2017.
“As we approach the key milestone of ReLive’s preliminary results, we are once again very encouraged by the positive recommendations of the DSMB that confirm Livatag®’s acceptable tolerance profile in terms of safety and side effects. Livatag® aims to treat a challenging pathology, patients with advanced HCC. This product candidate represents a potential new and innovative therapeutic option for patients suffering from this orphan and resistant cancer, and could become a potentially impactful catalyst for the Company,” commented Judith Greciet, CEO of Onxeo.
As per study protocol, the DSMB examines blind tolerance data from the ReLive trial twice a year. However, the DSMB does not receive any data that may enable an assessment of the efficacy of Livatag®.
Preliminary efficacy results from ReLive are expected by mid-2017.