BioAlliance Pharma: First Meeting of the DSMB of the ReLive Trial and Continuation Without Modification of the Phase III Clinical Trial With Livatag® in Primary Liver Cancer
12/20/2012 8:58:14 AM
PARIS--(BUSINESS WIRE)--Regulatory News: BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces that the European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) held its first meeting on the ReLive Phase III trial and recommended continuing it without modification to evaluate the efficacy of Livatag® (doxorubicin Transdrug™) in primary liver cancer. In order to ensure a regular safety monitoring of patients enrolled in ReLive, the organization of a Board of international experts was to meet every 6 months, and/or after inclusion of the first 25 patients, to review the safety data of patients included in the trial, and to recommend possible modifications of the protocol. This type of Board is usually organized in pivotal phase III clinical trials to assure patient safety and integrity of the trial.
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