Two key validation steps for Livatag achieved by BioAlliance Pharma

French orphan cancer drug developer BioAlliance Pharma (Euronext Paris: BIO) has announced the validation of its application for a Phase III clinical trial for Livatag (doxorubicin Transdrug) in the treatment of primary liver cancer submitted to the French drug regulation agency, the Afssaps. This will enable the review of the preclinical and clinical dossiers by the experts of the Agency.

Submitted on June 27, BioAlliance says the Phase III clinical trial application is based on particularly striking survival data observed in the Phase II trial (17-month increase in the median overall survival as compared to that of chemoembolization) together with a new administration scheme, validated on an animal model, enabling to significantly prevent acute pulmonary adverse events. This trial aims at demonstrating efficacy of Livatag on survival in patients with hepatocellular carcinoma after failure of or intolerance to sorafenib. A regular monitoring will be performed by an independent expert board.

Ph III to start next year