France-based BioAlliance Pharma has received authorisation to begin its randomised Phase III ReLive (Livatag) clinical trial in primary liver cancer in the US and Germany.
The move follows the review of the IND approval of the Livatag development programme by the US FDA and also the approval from the German health agency BfArM.
BioAlliance Pharma COO in charge of strategy and medical affairs Pierre Attali said the deployment strategy planned was to implement the clinical trial first in France, then to expand it to Europe and then to the US in 2014.
"The schedule is currently fully respected as the study is already implemented in Europe since last summer, and clinical operations will now be able to start in the US in order to open investigating centers," Attali said.
Regarding Europe, the company is also enlarging the trial to Germany after securing BfArM authorisation and this extension in a territory with a strong recruitment potential follows authorisations already secured in Spain, Italy, Russia, Hungary, Austria and Belgium.
The trial is aimed at showing the efficacy of Livatag on survival in 400 patients with hepatocellular carcinoma after failure or intolerance to sorafenib.
Twenty centres so far have been opened and more than 80 patients have been enrolled, in line with the recruitment objectives set by the company.
According to the company, the international extension of Livatag trial is necessary to meet the recruitment timelines objectives, which anticipate an end of recruitment in 2015 and preliminary results in 2016.
BioAlliance Pharma CEO Judith Greciet said the IND approval of the company’s Phase III clinical trial protocol in the US is a major milestone for them.
"In addition to the geographic expansion and the acceleration of patient enrollment, the implementation of ReLive in the United States will allow world’s leading experts in hepatology and oncology to build their own experience on the product," Greciet said.
A nanoparticle formulation of doxorubicin, Livatag is developed for the treatment of primary liver cancer.
Livatag uses Transdrug technology along with doxorubicin in the treatment of advanced primary liver cancer since the technology allows bypassing the mechanisms of multi-drug resistance developed by tumour cells.
Transdrug technology uses nanoparticles to help fight against chemotherapy resistance, a major mechanism in the failure of some anticancer drugs, that facilitate the penetration of the drug into the tumour cell and increase the cellular exposure to the drug.
Image: CT scan showing cholangiocarcinoma. Photo: courtesy of Filip em.