BioAlliance Pharma SA has initiated ReLive, its phase III clinical trial with Livatag (doxorubicin Transdrug), as scheduled in the advancement calendar of the project. This international, multi-centre, randomized phase III trial aims at evaluating the efficacy of Livatag on overall survival in nearly 400 patients suffering from Hepato Cellular Carcinoma, resistant or intolerant to sorafenib.
Almost 15 French sites expert in hepatology are already initiated and able to start recruiting the first patients. In the short and middle term, BioAlliance Pharma plans to extend the study to about 30 sites in France and abroad.
“Primary liver cancer is a particularly severe cancer and the need for efficacious treatments in advanced stage of the disease is major to improve patients’ survival”, declares Prof. Philippe Merle, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and principal investigator of the study. “Livatag represents a different therapeutic approach, as compared with targeted therapies currently under evaluation. Its nanoparticle formulation enables Livatag to bypass the resistance mechanisms of the tumour cell and assign it an interesting activity. This clinical trial should confirm it.”
The clinical trial batches of Livatag have been performed by qualified companies for injectable cytoxic products in nanoparticle form, in collaboration with the BioAlliance Pharma’s team specialized in industrial development that ensured the transmission of its know-how specific to nanoparticle Transdrug technology, and followed throughout the process. The clinical batches will be sent to the investigating sites in the next days. At last, the European independent Board of experts of the ReLive trial has met, with Pr. Michel Beaugrand (Jean Verdier University Hospital, Paris) as President and Pr. Jordi Bruix (Hospital Clinic i Provincial, Barcelona), as Vice-President. It will perform a regular monitoring of the study.
“All necessary authorizations and conditions are now in place to enable us to actually start the ReLive trial; the investigators can now screen and treat their first patients. The need for alternative therapeutics in primary advanced liver cancer is crucial and this trial should enable to establish the efficacy and the tolerance of Livatag in this indication. This last step of the product development is now launched, barely one year after announcement of the phase II preliminary results, and in line with the expected schedule, this is a substantial team performance”, comments Judith Greciet, CEO of BioAlliance Pharma. “Livatag is the leader of our “Orphan Oncology product” portfolio, core of the Company’s growth strategy, and represents a very strong asset for BioAlliance, with a sales potential above 800 million Euros. Implementation and realization of ReLive are indeed key steps to value this company’s strong asset.”