专注于孤儿药研发的BioAlliance制药4月15日宣布，负责ReLive III其试验的数据安全和监测委员会（DSMB）欧洲独立专家委员会已举行第4次会议，再次一致建议继续推进该项研究而无需修改试验方案。DSMB每6个月召开一次会议，评估Livatag（doxorubicin nanoparticle，阿霉素纳米颗粒）的耐受性并确保患者安全。
ReLive是一项国际性、随机III其临床试验，旨在证明Livatag用于既往经安进（Amgen）和拜耳（Bayer）多吉美（Nexavar，通用名：sorafenib，索拉非尼）治疗失败或不耐受的400例晚期肝癌（原发性肝癌）患者的生存疗效。该公司预计，若最终获批，Livatag的年销售潜力将达到8亿欧（约合11亿美元）。
BioAlliance Pharma gets DSMB recommendation to continue phase III trial with Livatag in primary liver cancer
BioAlliance Pharma SA, an innovative company specialised in the development of drugs in orphan oncology diseases, announced that the European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) in charge of the safety profile of the ReLive Phase III trial, has held its fourth meeting and once more unanimously recommended continuing the study without modification.
The DSMB meets every 6 months and or after reaching 75 treated patients to eva1uate the tolerance of Livatag and to ensure patient safety. For the fourth time since November 2012, the DSMB unanimously recommended to continue the study without modification, based on its positive assessment of all safety data of Livatag and thus confirmed the good safety profile of the product.
ReLive is an international, randomised 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.
As of today, ab0ut 40 centres are opened in Europe and more than 25 per cent of patients are enrolled, on track with the plan. The trial is still expanding in Europe and implementation of investigator centres is ongoing in the United States further to the green light obtained from the FDA last December. The recruitment should be completed end of 2015 for expected data end of 2016.
“Each new positive recommendation from our DSMB – now covering over 25 per cent of enrolled patients – strengthens the tolerance eva1uation of Livatag,” comments Judith Greciet, chief executive officer of BioAlliance Pharma. “This positive eva1uation is a major step forward in the overall assessment of this drug being developed for a rare cancer with no or few therapeutic alternatives, and representing sales potential estimated at nearly €800 million.”
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