Danish pharma company Onxeo has completed enrollment of patients in the phase 3 clinical trial of its advanced hepatocellular carcinoma (HCC) drug Livatag (doxorubicin transdrug).
Dubbed ReLive, the phase 3 trial will evaluate the efficacy of intravenous (IV) administration of Livatag for treating the aggressive form of primary liver cancer. It will have patients with advanced HCC who either failed getting treated by sorafenib or had intolerance to the kinase inhibitor drug.
The trial is being carried out in 11 countries including the US while the rest of them are spread across Europe, Middle East and North Africa as part of the pharma’s global development plan.
Onxeo CEO Judith Greciet said: “Completion of enrollment 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.”
390 patients taking part in the phase 3 trial and have been randomized into two groups. While the first group with around 260 patients will be subjected to Livatag treatment, the remaining will form the comparative group and will be given the best standard of care.
A nanoparticle formulation of doxorubicin, Livatag was developed based on the Transdrug technology of Onxeo.
The technology helps the drug to penetrate into the tumor cell and increase the target DNA exposure to the drug, and subsequently bypassing the multi-drug resistance mechanisms developed by tumor cells.