Onxeo Completes Enrollment in Phase III Study of Livatag® for the Treatment of Hepatocellular Carcinoma
Business Wire Business WireJanuary 24, 2017
PARIS & COPENHAGEN, Denmark--(BUSINESS WIRE)--
Onxeo S.A. (ONXEO.PA) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ Copenhagen: ONXEO), a biopharmaceutical company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced the completion of enrollment in ReLive, the international Phase III clinical trial evaluating Livatag® for the treatment of advanced hepatocellular carcinoma (HCC).
"Advanced HCC is a particularly severe form of liver cancer with a high mortality and very few treatment options," commented Pr. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Principal Investigator of the ReLive study. "All patients have now been enrolled in the Phase III trial of Livatag® and the DSMB recommendations point towards an adequte safety profile. We hope this treatment will become a new option for patients with advanced HCC for whom there is a strong unmet therapeutic need and we are now looking forward to the preliminary efficacy data expected within a few months."
The ReLive trial is evaluating the efficacy of intravenous (IV) administration of Livatag® (doxorubicin transdrug®) in patients with advanced HCC after failure or intolerance to sorafenib compared to the best standard of care chosen by the physician. In line with Onxeo’s international development plan, the company has conducted this Phase III trial in 11 countries (Europe, USA, MENA*).
To date, 390 patients have been randomized, with about 260 patients in the Livatag® treatment group and 130 in the comparative group (best standard of care). The completion of patient randomization is an important milestone that confirms the expected timeline of issuing the preliminary efficacy outcomes of the study mid-2017.