Onxeo has received the recommendation from an independet European board, Data Safety Monitoring Board (DSMB), Livatag Phase III trial, “ReLive”, to continue the study without modification.
Onexo, a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, pointed out that the nine consecutive positive DSMB recommendations reinforce the acceptable safety profile of Livatag.
The ReLive is a Phase III study that looks at the efficacy of intravenous (IV) taking of Livatag in patients with advanced hepatocellular carcinoma (HCC) after failure or intolerance to sorafenib.
Soon to reach 400 patients
According to Onexo, 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.
Judith Greciet, CEO of Onxeo, said: “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.”