Blaze Bioscience的光学成像剂BLZ-100用于"点亮"儿童中枢神经系统肿瘤,获FDA授予快速通道指定

2020-04-08 MedSci原创 MedSci原创

BLZ-100是一种靶向肿瘤的光学成像剂,通过在手术过程中实时、高分辨率地显示癌细胞,可以更加高效地切除癌组织,保留健康组织。

生物技术公司Blaze Bioscience宣布其用于儿童脑肿瘤成像的tozuleristide(BLZ-100),获得美国食品和药物管理局(FDA)的快速通道指定。

BLZ-100是一种靶向肿瘤的光学成像剂,由靶向肽和荧光染料组成,后者发射近红外(NIR)范围的光。通过在手术过程中实时、高分辨率地显示癌细胞,可以更加高效地切除癌组织,保留健康组织。

BLZ-100已在四个1期临床试验中进行了测试,并已证明在脑癌、乳腺癌和皮肤癌临床实验中得到证明。BLZ-100的其他潜在应用包括前列腺癌、肺癌、结肠直肠癌和其他实体瘤癌症。目前正在对儿童中枢神经系统肿瘤(NCT03579602)进行关键的2/3期临床研究,评估研究BLZ-100。

Blaze Bioscience开发执行副总裁Dennis Miller博士说:"获得快速通道指定是对我们的儿科脑癌手术研究的重要认可。小儿脑瘤仍然是儿童和青少年癌症死亡的主要原因。我们希望与FDA保持持续的合作关系,以加快产品批准速度和其他产品开发工作。"

原始出处:

https://www.firstwordpharma.com/node/1713862?tsid=4

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createdBy=b88a5514460, createdName=qidongfanjian, createdTime=Fri Apr 10 01:12:23 CST 2020, time=2020-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515545, encodeId=9bd71515545de, content=<a href='/topic/show?id=b8b82229451' target=_blank style='color:#2F92EE;'>#中枢神经系统肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22294, encryptionId=b8b82229451, topicName=中枢神经系统肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a82c10820207, createdName=ms8888626721583891, createdTime=Fri Apr 10 01:12:23 CST 2020, time=2020-04-10, status=1, ipAttribution=)]
    2020-09-13 sunylz
  5. 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  6. 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  7. 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  8. 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createdBy=b88a5514460, createdName=qidongfanjian, createdTime=Fri Apr 10 01:12:23 CST 2020, time=2020-04-10, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1515545, encodeId=9bd71515545de, content=<a href='/topic/show?id=b8b82229451' target=_blank style='color:#2F92EE;'>#中枢神经系统肿瘤#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=45, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=22294, encryptionId=b8b82229451, topicName=中枢神经系统肿瘤)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a82c10820207, createdName=ms8888626721583891, createdTime=Fri Apr 10 01:12:23 CST 2020, time=2020-04-10, status=1, ipAttribution=)]
    2020-04-10 jichang
  9. 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