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Proxalutamide用于治疗美国住院COVID-19患者的III期临床试验，首次对患者给药

2021-10-04 Allan MedSci原创

Covid-19Proxalutamide（GT0918）
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Kintor Pharma今天宣布，于10月1日进行的Proxalutamide III期临床试验（用于治疗住院COVID-19患者）已在美国招募并给药了第一位患者。

Kintor Pharma今天宣布，于10月1日进行的Proxalutamide III期临床试验（用于治疗住院COVID-19患者）已在美国招募并给药了第一位患者。Proxalutamide是唯一进入III期MRCT临床试验的小分子口服药物，用于治疗住院COVID-19患者。

美国III期试验是一项随机、双盲、安慰剂对照、多区域关键性试验，旨在评估proxalutamide在住院 COVID-19患者中的疗效和安全性。试验的主要终点是第30天评估的持续恢复时间，试验的次要终点是30天死亡率。这项关键研究已获得美国FDA、中国CDE、菲律宾FDA和巴西ANVISA的批准，并正在寻求欧洲和亚洲更多监管机构的批准。

Proxalutamide是一种非甾体类抗雄激素（AR）药物，是雄激素受体的选择性高亲和力拮抗剂，正在开发用于COVID-19、前列腺癌和乳腺癌的潜在治疗。Proxalutamide靶向AR-ACE2/TMPRSS2信号轴可以通过转录下调TMRPSS2和ACE2的表达来显著抑制病毒进入宿主细胞。同时，Proxalutamide通过激活Nrf2通路促进病原体清除并减少炎症，该通路激活多种抗氧化基因和蛋白质，并降低细胞因子反应的强度，这可能对COVID-19感染患者具有临床益处。

Kintor Pharma创始人、董事长兼首席执行官Youzhi Tong博士评论说：“作为AR拮抗剂，proxalutamide已经展示了明确的作用机制，包括下调ACE-2和 TMPRSS2蛋白，提高NrF-2的表达并抑制IL-6和TNF-α等，从而最大限度地减少细胞因子风暴和组织损伤，这表明proxalutamide可作为治疗重症COVID-19患者的可能方法”。

 

原始出处：

https://www.firstwordpharma.com/node/1868315?tsid=4

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    2022-05-07 juliusluan78

    #III#

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    2022-09-02 医生2402

    #I期临床#

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content=<a href='/topic/show?id=b317956200' target=_blank style='color:#2F92EE;'>#III期#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=25, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9562, encryptionId=b317956200, topicName=III期)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=a12645, createdName=智智灵药, createdTime=Wed Oct 06 12:05:20 CST 2021, time=2021-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1602392, encodeId=0f571602392d8, content=<a href='/topic/show?id=2f801469e57' target=_blank style='color:#2F92EE;'>#PRO#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=16, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=14697, encryptionId=2f801469e57, topicName=PRO)], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=a60b18898917, createdName=sunylz, createdTime=Wed Oct 06 12:05:20 CST 2021, time=2021-10-06, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1057707, encodeId=9c37105e707cb, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f9435503843, createdName=ms2000001420109698, createdTime=Mon Oct 04 22:58:41 CST 2021, time=2021-10-04, status=1, ipAttribution=)]
    2022-03-09 kksonne

    #II期临床试验#

    0

  5. [GetPortalCommentsPageByObjectIdResponse(id=1916481, encodeId=1d381916481e3, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat May 07 18:05:20 CST 2022, time=2022-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088871, encodeId=d49f20888e156, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1057707, encodeId=9c37105e707cb, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f9435503843, createdName=ms2000001420109698, createdTime=Mon Oct 04 22:58:41 CST 2021, time=2021-10-04, status=1, ipAttribution=)]
    2021-10-06 zhangph

    #COVID-19患者#

    0

  6. [GetPortalCommentsPageByObjectIdResponse(id=1916481, encodeId=1d381916481e3, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat May 07 18:05:20 CST 2022, time=2022-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088871, encodeId=d49f20888e156, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1057707, encodeId=9c37105e707cb, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f9435503843, createdName=ms2000001420109698, createdTime=Mon Oct 04 22:58:41 CST 2021, time=2021-10-04, status=1, ipAttribution=)]
    2021-10-06 guihongzh

    #II期临床#

    0

  7. [GetPortalCommentsPageByObjectIdResponse(id=1916481, encodeId=1d381916481e3, content=<a href='/topic/show?id=c5a89550ff' target=_blank style='color:#2F92EE;'>#III#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=33, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=9550, encryptionId=c5a89550ff, topicName=III)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=e68e415, createdName=juliusluan78, createdTime=Sat May 07 18:05:20 CST 2022, time=2022-05-07, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=2088871, encodeId=d49f20888e156, content=<a href='/topic/show?id=53961018913' target=_blank style='color:#2F92EE;'>#I期临床试验#</a>, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[TopicDto(id=10189, encryptionId=53961018913, topicName=I期临床试验)], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=45b2276, 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1057707, encodeId=9c37105e707cb, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f9435503843, createdName=ms2000001420109698, createdTime=Mon Oct 04 22:58:41 CST 2021, time=2021-10-04, status=1, ipAttribution=)]
    2021-10-06 guihongzh

    #III期临床试验#

    0

  8. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1057707, encodeId=9c37105e707cb, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f9435503843, createdName=ms2000001420109698, createdTime=Mon Oct 04 22:58:41 CST 2021, time=2021-10-04, status=1, ipAttribution=)]
    2021-10-06 智智灵药

    #III期#

    0

  9. 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status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=1057707, encodeId=9c37105e707cb, content=👍, beContent=null, objectType=article, channel=null, level=null, likeNumber=68, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=null, createdBy=f9435503843, createdName=ms2000001420109698, createdTime=Mon Oct 04 22:58:41 CST 2021, time=2021-10-04, status=1, ipAttribution=)]
    2021-10-06 sunylz

    #PRO#

    0

  10. 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    2021-10-04 ms2000001420109698

    👍

    0

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胸部CT对疾病监测至关重要，时间是充分评估肺部恢复能力的关键因素。

Am J Resp Crit Care：半乳糖凝集素-3抑制剂治疗COVID-19肺炎

在COVID-19肺炎中，吸入GB013治疗的耐受性良好，达到了临床相关的血浆浓度。该研究的数据支持更大规模的临床试验来明确GB013的临床疗效。

European Radiology：如何实现影像学的标准COVID-19全自动预测？

放射组学是一种利用数学算法量化医学成像中病变的表型特征的方法，可用于预测疾病的严重程度和进展。

Lenzilumab 治疗 COVID-19 住院患者，未达到主要终点

FDA 已经拒绝了该公司寻求紧急使用该疗法治疗新住院 COVID-19 患者的请求。美国监管机构确定，它无法得出 lenzilumab 的潜在益处超过潜在风险的结论。