Approval to start ReLive (Livatag®) Phase III Clinical Trial in Primary Liver Cancer in the US and Germany

BioAlliance Pharma SA (Euronext Paris – BIO), an innovative Company dedicated to the development of orphan oncology and to supportive care products, announces that it has received authorization to start its Phase III ReLive clinical trial in primary liver cancer in the US (IND approval), following the review of the Livatag® development program by the FDA, as well as in Germany after the German health agency green light.

“The deployment strategy planned was to implement the clinical trial first in France, then to expand it to Europe and then to the United States 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 U.S in order to open investigating centers “, stated Pierre Attali, COO in charge of Strategy and Medical affairs of BioAlliance Pharma.

Regarding Europe, BioAlliance Pharma is also enlarging the study to Germany following the authorization granted by the BfArM (German health agency). This extension in a territory with a strong recruitment potential follows authorizations already obtained in Spain, Italy, Russia, Hungary, Austria and Belgium.

ReLive, an international phase III randomized trial, aims to demonstrate the efficacy of Livatag® on survival in 400 patients with hepatocellular carcinoma after failure or intolerance to sorafenib. To date, twenty centers have been opened and more than 80 patients have been enrolled, in line with the recruitment objectives set by 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.

“The IND approval of our Phase III clinical trial protocol in the United States is a key milestone for BioAlliance. 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”, stated Judith Greciet, CEO of BioAlliance Pharma.

 

 

131204EN Livatag IND