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AU-011治疗脉络膜黑色素瘤取得突破进展

2019-01-10 MedSci MedSci原创

眼科肿瘤新型靶向治疗开发领域的领导者Aura Biosciences近日宣布,它已收到美国食品和药品管理局(FDA)关于AU-011进行III临床试验(STARBRIGHT)的书面确认,旨在评估光激活的AU-011治疗脉络膜黑色素瘤患者有效性和安全性。

眼科肿瘤新型靶向治疗开发领域的领导者Aura Biosciences近日宣布,它已收到美国食品和药品管理局(FDA)关于AU-011进行III临床试验(STARBRIGHT)的书面确认,旨在评估光激活的AU-011治疗脉络膜黑色素瘤患者有效性和安全性。STARBRIGHT计划将包括两个小型的临床试验,旨在评估AU-011与对照组治疗脉络膜黑色素瘤患者的安全性和有效性。这两项名为STARBRIGHT 1STARBRIGHT 3的试验将是全球性、多中心、随机的。主要终点包括肿瘤控制和视力保持。

Aura首席执行官Elisabet de los Pinos博士说:我们很高兴收到FDA关于STARBRIGHT试验的明确指导,以便能够满足美国市场批准的科学和法规要求。目前可用于脉络膜黑色素瘤的疗法具有导致视力丧失的风险,特别是对于位于中央凹或视盘附近的黑素瘤患者。但光活化的AU-011Ib/II期研究表明该药物具有良好的耐受性,在长期随访中具有明确的肿瘤控制和视力保持能力


原始出处:

http://www.firstwordpharma.com/node/1615860?tsid=4#axzz5bnF206kJ

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    2019-07-05 sunylz
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