French-based biopharmaceutical firm Onxeo has closed enrolment for its Phase III clinical trial (ReLive) of Livatag for the treatment of advanced hepatocellular carcinoma (HCC), a primary liver cancer.
A nanoparticle formulation of doxorubicin, Livatag utilises the firm's Transdrug technology to enable the penetration of the drug into the tumour cell, as well as enhance the exposure of target DNA to the drug.
The trial currently includes a total of 390 randomised patients, of which about 260 are in the Livatag treatment group and the remaining 130 in the comparative group.
Conducted in 11 countries, the ReLive trial is assessing the efficacy of Livatag, administered intravenously in patients with advanced HCC.
Onxeo chief executive officer Judith Greciet said: “Completion of enrolment in ReLive marks a significant milestone for the HCC community.
"This is a major step forward in the development of Livatag as a new therapeutic option in a pathology, for which there is a strong need for new treatment.
"It is also a major achievement for Onxeo, which demonstrates its ability to complete a large international Phase III trial and marks a major value creation catalyst in line with the expected publication of preliminary results in mid-2017."
Livatag aids doxorubicin to bypass the mechanisms of multi-drug resistance developed by tumour cells and accumulates in the liver cells.
To date, the nine reviews on ReLive trial performed by Data Safety and Monitoring Board (DSMB) have indicated a positive safety profile of the drug.
Image: Hepatocellular carcinoma. Photo: courtesy of Ed Uthman/Wikipedia.