{"id":5329,"date":"2022-06-17T02:02:51","date_gmt":"2022-06-17T02:02:51","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=5329"},"modified":"2023-08-29T17:54:29","modified_gmt":"2023-08-29T17:54:29","slug":"kazia-therapeutics-us-fda-orphan-drug-designation-paxalisib-childhood-brain-cancer","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=5329","title":{"rendered":"Kazia Therapeutics\u83b7\u5f97\u7f8e\u56fdFDA\u5bf9\u9ad8\u4fb5\u88ad\u6027\u513f\u7ae5\u8111\u764cpaxalisib\u5b64\u513f\u836f\u8ba4\u5b9a"},"content":{"rendered":"

Kazia Therapeutics (ASX: KZA) \u56e0\u5176\u4e3b\u8981\u5019\u9009\u836f\u7269 paxalisib \u6cbb\u7597\u4e00\u79cd\u7f55\u89c1\u4e14\u9ad8\u5ea6\u4fb5\u88ad\u6027\u7684\u513f\u7ae5\u8111\u764c\u800c\u83b7\u5f97\u4e86\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (United States Food and Drug Administration)\u7684\u5b64\u513f\u836f\u6307\u5b9a (ODD)\u3002<\/p>\n

ODD \u4e13\u95e8\u7528\u4e8e paxalisib \u6cbb\u7597\u975e\u5178\u578b\u6a2a\u7eb9\u808c\/\u7578\u80ce\u7624\uff08AT\/RT \uff09\uff0c\u4f5c\u4e3a\u6307\u5b9a\u7684\u4e00\u90e8\u5206\uff0c FDA \u5c06\u514d\u9664\u4e0e\u672a\u6765\u5728 AT\/RT \u76d1\u7ba1\u5907\u6848\u76f8\u5173\u7684\u8d39\u7528\u3002<\/p>\n

Kazia \u6307\u51fa\uff0c\u8fd9\u53ef\u80fd\u4f1a\u5728 2022 \u8d22\u5e74\u4e3a\u516c\u53f8\u8282\u7701 300 \u4e07\u7f8e\u5143\u7528\u4e8e\u63a8\u8fdb paxalisib \u4f5c\u4e3a AT\/RT \u6cbb\u7597\u7684\u7533\u8bf7\u8d39\u3002<\/p>\n

\u201c\u513f\u7ae5\u8111\u764c\u5df2\u6210\u4e3a paxalisib \u8ba1\u5212\u7684\u4e00\u4e2a\u91cd\u8981\u5173\u6ce8\u9886\u57df\uff0c\u201dKazia \u9996\u5e2d\u6267\u884c\u5b98 James Garner \u535a\u58eb\u89e3\u91ca\u8bf4\u3002<\/p>\n

\u201c\u591a\u5e74\u6765\uff0c\u6211\u4eec\u4e00\u76f4\u5728\u4e0e\u51e0\u4f4d\u4e16\u754c\u9886\u5148\u7684\u7814\u7a76\u4eba\u5458\u5408\u4f5c\uff0c\u7814\u7a76\u5f25\u6f2b\u6027\u8111\u6865\u8111\u80f6\u8d28\u7624\u2014\u2014\u6700\u5177\u4fb5\u88ad\u6027\u7684\u513f\u7ae5\u764c\u75c7\u4e4b\u4e00\u3002\u201d<\/p>\n

Garner \u535a\u58eb\u8bf4\uff0c\u6700\u8fd1\u7684\u6570\u636e\u663e\u793a\uff0cpaxalisib \u6709\u53ef\u80fd\u5728 AT\/RT \u4e2d\u53d7\u76ca\uff0c\u8fd9\u662f\u53e6\u4e00\u79cd\u513f\u7ae5\u8111\u764c\uff0c\u73b0\u6709\u6cbb\u7597\u201c\u6548\u679c\u4e0d\u4f73\u201d\u3002<\/p>\n

\u201c\u8fd9\u5bf9 paxalisib \u6765\u8bf4\u662f\u4e00\u4e2a\u91cd\u8981\u7684\u65b0\u673a\u4f1a\uff0c\u6211\u4eec\u5c06\u7ee7\u7eed\u4e0e\u6211\u4eec\u7684\u5408\u4f5c\u8005\u548c\u987e\u95ee\u4e00\u8d77\u70ed\u60c5\u5730\u63a2\u7d22\u8fd9\u4e2a\u673a\u4f1a\uff0c\u201d\u4ed6\u8865\u5145\u9053\u3002<\/p>\n

\u5b64\u513f\u836f\u6307\u5b9a<\/h2>\n

FDA \u7684 ODD \u88ab\u6388\u4e88\u88ab\u8ba4\u4e3a\u6709\u5e0c\u671b\u6cbb\u7597\u7f55\u89c1\u201c\u5b64\u513f\u201d\u75be\u75c5\u7684\u836f\u7269\u3002\u8fd9\u4e9b\u5b64\u513f\u75be\u75c5\u5728\u7f8e\u56fd\u901a\u5e38\u88ab\u5b9a\u4e49\u4e3a\u6bcf\u5e74\u5c11\u4e8e 200,000 \u4f8b\u75c5\u4f8b\u3002<\/p>\n

\u5982\u679c\u4e00\u5bb6\u516c\u53f8\u83b7\u5f97\u4e86 ODD\uff0c\u5b83\u53ef\u4ee5\u63d0\u4f9b\u957f\u8fbe 7 \u5e74\u7684\u5b64\u513f\u836f\u72ec\u5360\u671f\uff0c\u5728\u6b64\u671f\u95f4\uff0c\u7ade\u4e89\u5bf9\u624b\u65e0\u6cd5\u4f7f\u7528 Kazia \u7684\u6570\u636e\u5f00\u53d1 paxalisib \u7684\u901a\u7528\u7248\u672c\u2014\u2014\u6709\u6548\u5730\u5ef6\u957f\u4e86\u5546\u4e1a\u4ea7\u54c1\u7684\u5bff\u547d\u3002<\/p>\n

Kazia \u6307\u51fa\uff0cODD \u8fd8\u4e3a\u83b7\u5f97\u8d60\u6b3e\u8d44\u91d1\u3001\u534f\u8bae\u63f4\u52a9\u548c\u7a0e\u6536\u62b5\u514d\u63d0\u4f9b\u4e86\u673a\u4f1a\u3002<\/p>\n

\u8be5\u516c\u53f8\u5df2\u7ecf\u83b7\u5f97\u4e86\u7528\u4e8e\u6cbb\u7597\u6210\u4eba\u6076\u6027\u80f6\u8d28\u7624\u548c\u513f\u7ae5\u5f25\u6f2b\u6027\u8111\u6865\u8111\u80f6\u8d28\u7624\u7684 ODD\u3002<\/p>\n

\u63a8\u8fdbpaxalisib<\/h2>\n

Paxalisib \u662f\u7531Pacific Pediatric Neuro-Oncology Consortium (PNOC) \u8d5e\u52a9\u7684\u4e00\u9879\u9488\u5bf9\u5f25\u6f2b\u6027\u4e2d\u7ebf\u80f6\u8d28\u7624\u7684 II \u671f\u8bd5\u9a8c\u7684\u4e00\u90e8\u5206\uff0c\u8be5\u8bd5\u9a8c\u5305\u62ec\u5f25\u6f2b\u6027\u5185\u5728\u8111\u6865\u80f6\u8d28\u7624\u3002<\/p>\n

\u8be5\u7814\u7a76\u7ed3\u5408\u4e86\u51e0\u79cd\u7814\u7a76\u6027\u65b0\u836f\u7597\u6cd5\uff0c\u9884\u8ba1\u660e\u5e74\u5c06\u63d0\u4f9b\u521d\u6b65\u6570\u636e\u3002<\/p>\n

Paxalisib \u6cbb\u7597\u5f25\u6f2b\u6027\u8111\u6865\u8111\u80f6\u8d28\u7624\u7684 I \u671f\u7814\u7a76\u5373\u5c06\u5b8c\u6210\uff0c\u9884\u8ba1\u5728\u4eca\u5e74\u5e74\u5e95\u524d\u83b7\u5f97\u6700\u7ec8\u6570\u636e\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

Kazia Therapeutics (ASX: KZA) \u56e0\u5176\u4e3b\u8981\u5019\u9009\u836f\u7269 paxalisib \u6cbb\u7597\u4e00\u79cd\u7f55\u89c1\u4e14\u9ad8\u5ea6\u4fb5\u88ad\u6027\u7684\u513f\u7ae5\u8111\u764c\u800c\u83b7\u5f97\u4e86\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (United States Food and Drug Administration)\u7684\u5b64\u513f\u836f\u6307\u5b9a (ODD)\u3002 ODD \u4e13\u95e8\u7528\u4e8e paxalisib \u6cbb\u7597\u975e\u5178\u578b\u6a2a\u7eb9\u808c\/\u7578\u80ce\u7624\uff08AT\/RT \uff09\uff0c\u4f5c\u4e3a\u6307\u5b9a\u7684\u4e00\u90e8\u5206\uff0c FDA \u5c06\u514d\u9664\u4e0e\u672a\u6765\u5728 AT\/RT \u76d1\u7ba1\u5907\u6848\u76f8\u5173\u7684\u8d39\u7528\u3002 Kazia \u6307\u51fa\uff0c\u8fd9\u53ef\u80fd\u4f1a\u5728 2022 \u8d22\u5e74\u4e3a\u516c\u53f8\u8282\u7701 300 \u4e07\u7f8e\u5143\u7528\u4e8e\u63a8\u8fdb paxalisib \u4f5c\u4e3a AT\/RT \u6cbb\u7597\u7684\u7533\u8bf7\u8d39\u3002 \u201c\u513f\u7ae5\u8111\u764c\u5df2\u6210\u4e3a paxalisib \u8ba1\u5212\u7684\u4e00\u4e2a\u91cd\u8981\u5173\u6ce8\u9886\u57df\uff0c\u201dKazia \u9996\u5e2d\u6267\u884c\u5b98 James Garner \u535a\u58eb\u89e3\u91ca\u8bf4\u3002 \u201c\u591a\u5e74\u6765\uff0c\u6211\u4eec\u4e00\u76f4\u5728\u4e0e\u51e0\u4f4d\u4e16\u754c\u9886\u5148\u7684\u7814\u7a76\u4eba\u5458\u5408\u4f5c\uff0c\u7814\u7a76\u5f25\u6f2b\u6027\u8111\u6865\u8111\u80f6\u8d28\u7624\u2014\u2014\u6700\u5177\u4fb5\u88ad\u6027\u7684\u513f\u7ae5\u764c\u75c7\u4e4b\u4e00\u3002\u201d Garner \u535a\u58eb\u8bf4\uff0c\u6700\u8fd1\u7684\u6570\u636e\u663e\u793a\uff0cpaxalisib \u6709\u53ef\u80fd\u5728 AT\/RT \u4e2d\u53d7\u76ca\uff0c\u8fd9\u662f\u53e6\u4e00\u79cd\u513f\u7ae5\u8111\u764c\uff0c\u73b0\u6709\u6cbb\u7597\u201c\u6548\u679c\u4e0d\u4f73\u201d\u3002 \u201c\u8fd9\u5bf9 paxalisib \u6765\u8bf4\u662f\u4e00\u4e2a\u91cd\u8981\u7684\u65b0\u673a\u4f1a\uff0c\u6211\u4eec\u5c06\u7ee7\u7eed\u4e0e\u6211\u4eec\u7684\u5408\u4f5c\u8005\u548c\u987e\u95ee\u4e00\u8d77\u70ed\u60c5\u5730\u63a2\u7d22\u8fd9\u4e2a\u673a\u4f1a\uff0c\u201d\u4ed6\u8865\u5145\u9053\u3002 \u5b64\u513f\u836f\u6307\u5b9a FDA \u7684 ODD \u88ab\u6388\u4e88\u88ab\u8ba4\u4e3a\u6709\u5e0c\u671b\u6cbb\u7597\u7f55\u89c1\u201c\u5b64\u513f\u201d\u75be\u75c5\u7684\u836f\u7269\u3002\u8fd9\u4e9b\u5b64\u513f\u75be\u75c5\u5728\u7f8e\u56fd\u901a\u5e38\u88ab\u5b9a\u4e49\u4e3a\u6bcf\u5e74\u5c11\u4e8e 200,000… Continue reading Kazia Therapeutics\u83b7\u5f97\u7f8e\u56fdFDA\u5bf9\u9ad8\u4fb5\u88ad\u6027\u513f\u7ae5\u8111\u764cpaxalisib\u5b64\u513f\u836f\u8ba4\u5b9a<\/span><\/a><\/p>\n","protected":false},"author":3,"featured_media":10095,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[3],"tags":[498],"yoast_head":"\nKazia Therapeutics\u83b7\u5f97\u7f8e\u56fdFDA\u5bf9\u9ad8\u4fb5\u88ad\u6027\u513f\u7ae5\u8111\u764cpaxalisib\u5b64\u513f\u836f\u8ba4\u5b9a<\/title>\n<meta name=\"description\" content=\"Kazia Therapeutics (ASX: KZA) \u56e0\u5176\u4e3b\u8981\u5019\u9009\u836f\u7269 paxalisib \u6cbb\u7597\u4e00\u79cd\u7f55\u89c1\u4e14\u9ad8\u5ea6\u4fb5\u88ad\u6027\u7684\u513f\u7ae5\u8111\u764c\u800c\u83b7\u5f97\u4e86\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (United States Food and Drug Administration)\u7684\u5b64\u513f\u836f\u6307\u5b9a (ODD)\u3002\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kazia Therapeutics\u83b7\u5f97\u7f8e\u56fdFDA\u5bf9\u9ad8\u4fb5\u88ad\u6027\u513f\u7ae5\u8111\u764cpaxalisib\u5b64\u513f\u836f\u8ba4\u5b9a\" \/>\n<meta property=\"og:description\" content=\"Kazia Therapeutics (ASX: KZA) \u56e0\u5176\u4e3b\u8981\u5019\u9009\u836f\u7269 paxalisib \u6cbb\u7597\u4e00\u79cd\u7f55\u89c1\u4e14\u9ad8\u5ea6\u4fb5\u88ad\u6027\u7684\u513f\u7ae5\u8111\u764c\u800c\u83b7\u5f97\u4e86\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (United States Food and Drug Administration)\u7684\u5b64\u513f\u836f\u6307\u5b9a (ODD)\u3002\" \/>\n<meta property=\"og:url\" content=\"https:\/\/smallcapscn.x5view.co\/kazia-therapeutics-us-fda-orphan-drug-designation-paxalisib-childhood-brain-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"smallcapsCN\" \/>\n<meta property=\"article:published_time\" content=\"2022-06-17T02:02:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-08-29T17:54:29+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/smallcapscn.x5view.co\/wp-content\/uploads\/2023\/08\/Incannex-Healthcare-trading-halt-study-results-FDA-strategy-ASX-IHL.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"640\" \/>\n\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Lorna Nicholas\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Lorna Nicholas\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/smallcapscn.x5view.co\/kazia-therapeutics-us-fda-orphan-drug-designation-paxalisib-childhood-brain-cancer\/\",\"url\":\"https:\/\/smallcapscn.x5view.co\/kazia-therapeutics-us-fda-orphan-drug-designation-paxalisib-childhood-brain-cancer\/\",\"name\":\"Kazia 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