BioAlliance updates on Livatag development

14 May 2013

French orphan cancer drug developer BioAlliance Pharma (Euronext Paris: BIO) says that the International Independent Board of Experts' Data and Safety Monitoring Board (DSMB) again recommended continuing the ReLive Phase III trial without modification.

The DSMB meets every six months and/or after the recruitment of 75 patients to evaluate the tolerance of Livatag (doxorubicin Transdrug), and to ensure patient safety. On November 19, 2012, the DSMB unanimously recommended continuing the trial without modification. The DSMB renewed its recommendation at its recent meeting following the tolerance data review of Livatag.

Parallel to this, a data review by the French National Agency of Medicine and Health Safety Products (ANSM) was planned after enrollment of the first 25 patients. Authorization was also granted from the ANSM in April 2013 to further continue the ReLive trial.

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