Onxeo receives DSMB recommendation for Phase III Livatag study

The Data Safety Monitoring Board (DSMB) has awarded Onxeo S.A. with its ninth unanimous recommendation. The DSMB is an independent European board of experts charged with monitoring the safety of Onxeo’s Phase III Livatag study, called “ReLive.”
“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,” Onxeo CEO Judith Graciet said. “Enrollment 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 hepatocellular carcinoma (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.”
The DSMB recommendation supports Livatag’s safety profile.
The Phase III ReLive study is ongoing in centers around the globe. It is designed to assess the safety and effectiveness of Livatag’s administration through IVs in patients who have advanced HCC.