Onxeo announces positive DSMB recommendation for its Phase III trial with Livatag® in primary liver cancer
Onxeo SA (Euronext Paris, NASDAQ OMX Copenhagen - ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that the European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) in charge of the safety monitoring of the Livatag® Phase III trial has once again unanimously recommended continuing the study without modification.
“Each new positive recommendation from our DSMB further strengthens our confidence about Livatag® safety profile and confirms that so far, the product safety profile is as expected. This is of course of great importance for one of our most promising programs”, comments Judith Greciet, CEO of Onxeo.
ReLive is an international, randomized Phase III trial aiming at demonstrating the efficacy of Livatag® on survival in 400 patients with advanced HepatoCellular Carcinoma (primary liver cancer) after failure of intolerance to Sorafenib.
The Data Safety and Monitoring Board meets every 6 months to review the safety data of the ReLive trial and consequently makes recommendations on the conduct of the study. As in previous safety evaluations since trial’s initiation, the DSMB unanimously recommended to continue the study without modification, based on its positive assessment of the safety data of Livatag®. This fully positive recommendation confirms once more the good safety profile of the product.