{"id":6517,"date":"2023-03-09T01:19:46","date_gmt":"2023-03-09T01:19:46","guid":{"rendered":"\/\/smallcapscn.x5view.co\/?p=6517"},"modified":"2023-08-29T17:57:12","modified_gmt":"2023-08-29T17:57:12","slug":"prescient-therapeutics-fda-orphan-drug-status-ptx-100-treat-t-cell-lymphomas","status":"publish","type":"post","link":"https:\/\/smallcapscn.x5view.co\/?p=6517","title":{"rendered":"Prescient Therapeutics \u83b7\u5f97 FDA \u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624\u7684 PTX-100 \u5b64\u513f\u836f\u7269\u5730\u4f4d"},"content":{"rendered":"

\u4e34\u5e8a\u9636\u6bb5\u80bf\u7624\u5b66\u516c\u53f8 Prescient Therapeutics (ASX: PTX) \u7684\u4e3b\u8981\u5019\u9009\u836f\u7269 PTX-100 \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u7528\u4e8e\u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624 (TCL)\uff0c\u5305\u62ec\u76ae\u80a4 TCL (CTCL) )\u3002<\/p>\n

TCL \u662f\u4e00\u7ec4\u5728\u767d\u7ec6\u80de\uff08\u6dcb\u5df4\u7ec6\u80de\uff09\u751f\u957f\u5931\u63a7\u65f6\u53d1\u751f\u7684\u6dcb\u5df4\u7624\u3002<\/p>\n

\u603b\u7684\u6765\u8bf4\uff0cTCL \u4ee3\u8868\u4e86\u60a3\u8005\u9700\u6c42\u672a\u5f97\u5230\u6ee1\u8db3\u6216\u672a\u5f97\u5230\u6ee1\u8db3\u7684\u9886\u57df\uff0c\u5c24\u5176\u662f\u5728\u60a3\u6709\u590d\u53d1\u6216\u96be\u6cbb\u6027\u75be\u75c5\u7684\u4eba\u7fa4\u4e2d\u3002<\/p>\n

Prescient\u4e8e2022\u5e74\u5206\u522b\u83b7\u5f97\u5916\u5468TCL\uff08PTCL\uff09\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u968f\u540eCTCL\u4e5f\u7533\u8bf7\u83b7\u5f97\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\u3002<\/p>\n

FDA \u73b0\u5728\u6388\u4e88\u4e86\u6bd4 Prescient \u8981\u6c42\u66f4\u5e7f\u6cdb\u7684\u540d\u79f0\uff0c\u5176\u4e2d\u5305\u62ec\u6240\u6709 TCL\u3002<\/p>\n

\u5b64\u513f\u836f\u72b6\u6001<\/h2>\n

FDA \u7684\u5b64\u513f\u836f\u7269\u6307\u5b9a\u8ba1\u5212\u4e3a\u65e8\u5728\u5b89\u5168\u6709\u6548\u5730\u6cbb\u7597\u3001\u8bca\u65ad\u6216\u9884\u9632\u7f55\u89c1\u75be\u75c5\uff08\u5b9a\u4e49\u4e3a\u5f71\u54cd\u7f8e\u56fd\u4e0d\u5230 200,000 \u4eba\u7684\u75be\u75c5\uff09\u7684\u836f\u7269\u63d0\u4f9b\u5b64\u513f\u5730\u4f4d\u3002<\/p>\n

\u8be5\u8ba1\u5212\u4e3a\u6fc0\u52b1\u836f\u7269\u5f00\u53d1\u63d0\u4f9b\u4e86\u597d\u5904\uff0c\u5305\u62ec\u4ece\u83b7\u5f97\u76d1\u7ba1\u6279\u51c6\u8d77\u4e03\u5e74\u7684\u5e02\u573a\u72ec\u5360\u6743\u4fdd\u8bc1\uff1b \u5904\u65b9\u836f\u7528\u6237\u8d39\u7528\u6cd5\u6848 (PDUFA) \u8d39\u7528\u7684\u8c41\u514d\uff0c\u8be5\u8d39\u7528\u5728 2022 \u5e74\u4ef7\u503c\u8d85\u8fc7 310 \u4e07\u7f8e\u5143\u3002<\/p>\n

Prescient \u8463\u4e8b\u603b\u7ecf\u7406 Steven Yatomi-Clarke \u5bf9\u6307\u5b9a PTX-100 \u7528\u4e8e\u6cbb\u7597\u6240\u6709 TLC \u8868\u793a\u6b22\u8fce\u3002<\/p>\n

\u201c\u6211\u4eec\u5f88\u9ad8\u5174\u88ab FDA \u6388\u4e88\u5b64\u513f\u836f\u79f0\u53f7\uff0c\u6211\u4eec\u5f88\u9ad8\u5174\u6536\u5230\u6bd4\u6211\u4eec\u8981\u6c42\u66f4\u5e7f\u6cdb\u7684\u79f0\u53f7\uff0c\u201d\u4ed6\u8bf4\u3002<\/p>\n

\u201c\u73b0\u5728\uff0c\u8fd9\u786e\u5b9a\u4e86 PTX-100 \u5728\u4e34\u5e8a\u9700\u6c42\u672a\u5f97\u5230\u6ee1\u8db3\u6216\u672a\u5f97\u5230\u6ee1\u8db3\u7684\u66f4\u5e7f\u6cdb\u75be\u75c5\u4e2d\u4e03\u5e74\u7684\u5e02\u573a\u72ec\u5360\u6027\u3002\u201d<\/p>\n

First-in-class \u5316\u5408\u7269<\/h2>\n

PTX-100 \u662f\u4e00\u6d41\u7684\u5316\u5408\u7269\uff0c\u80fd\u591f\u963b\u65ad\u9999\u53f6\u57fa\u9999\u53f6\u57fa\u8f6c\u79fb\u9176-1 (GGT-1) \u764c\u75c7\u751f\u957f\u9176\u3002<\/p>\n

\u5b83\u901a\u8fc7\u6291\u5236\u764c\u7ec6\u80de\u4e2d Rho\u3001Rac \u548c Ral \u56de\u8def\u7684\u6fc0\u6d3b\u6765\u7834\u574f\u81f4\u764c Ras \u901a\u8def\uff0c\u4ece\u800c\u5bfc\u81f4\u7ec6\u80de\u51cb\u4ea1\uff08\u6216\u6b7b\u4ea1\uff09\u3002<\/p>\n

PTX-100 \u88ab\u8ba4\u4e3a\u662f\u4e16\u754c\u4e0a\u552f\u4e00\u5904\u4e8e\u4e34\u5e8a\u5f00\u53d1\u9636\u6bb5\u7684 GGT-1 \u6291\u5236\u5242\uff0c\u5e76\u5728 1 \u671f\u7814\u7a76\u548c\u6700\u8fd1\u7684\u8840\u6db2\u5b66\u548c\u5b9e\u4f53\u6076\u6027\u80bf\u7624\u7684 PK\/PD \u7bee\u5b50\u7814\u7a76\u4e2d\u8bc1\u660e\u4e86\u5b89\u5168\u6027\u548c\u65e9\u671f\u4e34\u5e8a\u6d3b\u6027\u3002<\/p>\n

\u8be5\u836f\u7269\u76ee\u524d\u6b63\u5904\u4e8e T \u7ec6\u80de\u6dcb\u5df4\u7624\u7684 1b \u671f\u6269\u5c55\u961f\u5217\u7814\u7a76\u4e2d\uff0c\u5df2\u663e\u793a\u51fa\u4ee4\u4eba\u9f13\u821e\u7684\u7597\u6548\u4fe1\u53f7\u548c\u5b89\u5168\u6027\u3002<\/p>\n

\u65b0\u578b\u7ed3\u6784\u57df\u6291\u5236\u5242<\/h2>\n

Prescient \u7684\u53e6\u4e00\u79cd\u9776\u5411\u7597\u6cd5 PTX-200 \u662f\u4e00\u79cd\u65b0\u578b PH \u7ed3\u6784\u57df\u6291\u5236\u5242\uff0c\u65e8\u5728\u963b\u6b62\u79f0\u4e3a Akt \u7684\u80bf\u7624\u5b58\u6d3b\u9014\u5f84\uff0c\u8be5\u9014\u5f84\u5728\u4e73\u817a\u764c\u548c\u5375\u5de2\u764c\u4ee5\u53ca\u767d\u8840\u75c5\u7684\u53d1\u5c55\u4e2d\u8d77\u7740\u5173\u952e\u4f5c\u7528\u3002<\/p>\n

\u4e0e\u5176\u4ed6\u9776\u5411 Akt \u6291\u5236\u7684\u5019\u9009\u836f\u7269\u4e0d\u540c\uff0cPTX-200 \u5177\u6709\u4e00\u79cd\u65b0\u7684\u4f5c\u7528\u673a\u5236\uff0c\u53ef\u4ee5\u7279\u5f02\u6027\u6291\u5236 Akt \u800c\u6ca1\u6709\u975e\u7279\u5f02\u6027\u6fc0\u9176\u6291\u5236\u4f5c\u7528\u3002<\/p>\n

\u5b83\u76ee\u524d\u6b63\u5904\u4e8e\u590d\u53d1\u548c\u96be\u6cbb\u6027\u6025\u6027\u9ad3\u6027\u767d\u8840\u75c5\u7684 1b \/ 2 \u671f\u8bd5\u9a8c\u4e2d\uff0c\u8fc4\u4eca\u4e3a\u6b62\u5df2\u5bfc\u81f4\u56db\u6b21\u7f13\u89e3\u3002<\/p>\n

PTX-200 \u5148\u524d\u5728\u4e0e HER2 \u9634\u6027\u4e73\u817a\u764c\u548c\u590d\u53d1\u6027\u6216\u6301\u7eed\u6027\u94c2\u8010\u836f\u5375\u5de2\u764c\u76f8\u5173\u7684\u8bd5\u9a8c\u4e2d\u4ea7\u751f\u4e86\u4ee4\u4eba\u9f13\u821e\u7684\u7ed3\u679c\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

\u4e34\u5e8a\u9636\u6bb5\u80bf\u7624\u5b66\u516c\u53f8 Prescient Therapeutics (ASX: PTX) \u7684\u4e3b\u8981\u5019\u9009\u836f\u7269 PTX-100 \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u7528\u4e8e\u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624 (TCL)\uff0c\u5305\u62ec\u76ae\u80a4 TCL (CTCL) )\u3002 TCL \u662f\u4e00\u7ec4\u5728\u767d\u7ec6\u80de\uff08\u6dcb\u5df4\u7ec6\u80de\uff09\u751f\u957f\u5931\u63a7\u65f6\u53d1\u751f\u7684\u6dcb\u5df4\u7624\u3002 \u603b\u7684\u6765\u8bf4\uff0cTCL \u4ee3\u8868\u4e86\u60a3\u8005\u9700\u6c42\u672a\u5f97\u5230\u6ee1\u8db3\u6216\u672a\u5f97\u5230\u6ee1\u8db3\u7684\u9886\u57df\uff0c\u5c24\u5176\u662f\u5728\u60a3\u6709\u590d\u53d1\u6216\u96be\u6cbb\u6027\u75be\u75c5\u7684\u4eba\u7fa4\u4e2d\u3002 Prescient\u4e8e2022\u5e74\u5206\u522b\u83b7\u5f97\u5916\u5468TCL\uff08PTCL\uff09\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u968f\u540eCTCL\u4e5f\u7533\u8bf7\u83b7\u5f97\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\u3002 FDA \u73b0\u5728\u6388\u4e88\u4e86\u6bd4 Prescient \u8981\u6c42\u66f4\u5e7f\u6cdb\u7684\u540d\u79f0\uff0c\u5176\u4e2d\u5305\u62ec\u6240\u6709 TCL\u3002 \u5b64\u513f\u836f\u72b6\u6001 FDA \u7684\u5b64\u513f\u836f\u7269\u6307\u5b9a\u8ba1\u5212\u4e3a\u65e8\u5728\u5b89\u5168\u6709\u6548\u5730\u6cbb\u7597\u3001\u8bca\u65ad\u6216\u9884\u9632\u7f55\u89c1\u75be\u75c5\uff08\u5b9a\u4e49\u4e3a\u5f71\u54cd\u7f8e\u56fd\u4e0d\u5230 200,000 \u4eba\u7684\u75be\u75c5\uff09\u7684\u836f\u7269\u63d0\u4f9b\u5b64\u513f\u5730\u4f4d\u3002 \u8be5\u8ba1\u5212\u4e3a\u6fc0\u52b1\u836f\u7269\u5f00\u53d1\u63d0\u4f9b\u4e86\u597d\u5904\uff0c\u5305\u62ec\u4ece\u83b7\u5f97\u76d1\u7ba1\u6279\u51c6\u8d77\u4e03\u5e74\u7684\u5e02\u573a\u72ec\u5360\u6743\u4fdd\u8bc1\uff1b \u5904\u65b9\u836f\u7528\u6237\u8d39\u7528\u6cd5\u6848 (PDUFA) \u8d39\u7528\u7684\u8c41\u514d\uff0c\u8be5\u8d39\u7528\u5728 2022 \u5e74\u4ef7\u503c\u8d85\u8fc7 310 \u4e07\u7f8e\u5143\u3002 Prescient \u8463\u4e8b\u603b\u7ecf\u7406 Steven Yatomi-Clarke \u5bf9\u6307\u5b9a PTX-100 \u7528\u4e8e\u6cbb\u7597\u6240\u6709 TLC \u8868\u793a\u6b22\u8fce\u3002 \u201c\u6211\u4eec\u5f88\u9ad8\u5174\u88ab FDA \u6388\u4e88\u5b64\u513f\u836f\u79f0\u53f7\uff0c\u6211\u4eec\u5f88\u9ad8\u5174\u6536\u5230\u6bd4\u6211\u4eec\u8981\u6c42\u66f4\u5e7f\u6cdb\u7684\u79f0\u53f7\uff0c\u201d\u4ed6\u8bf4\u3002 \u201c\u73b0\u5728\uff0c\u8fd9\u786e\u5b9a\u4e86 PTX-100 \u5728\u4e34\u5e8a\u9700\u6c42\u672a\u5f97\u5230\u6ee1\u8db3\u6216\u672a\u5f97\u5230\u6ee1\u8db3\u7684\u66f4\u5e7f\u6cdb\u75be\u75c5\u4e2d\u4e03\u5e74\u7684\u5e02\u573a\u72ec\u5360\u6027\u3002\u201d First-in-class… Continue reading Prescient Therapeutics \u83b7\u5f97 FDA \u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624\u7684 PTX-100 \u5b64\u513f\u836f\u7269\u5730\u4f4d<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":18801,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[3],"tags":[171],"yoast_head":"\nPrescient Therapeutics \u83b7\u5f97 FDA \u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624\u7684 PTX-100 \u5b64\u513f\u836f\u7269\u5730\u4f4d<\/title>\n<meta name=\"description\" content=\"\u4e34\u5e8a\u9636\u6bb5\u80bf\u7624\u5b66\u516c\u53f8 Prescient Therapeutics (ASX: PTX) \u7684\u4e3b\u8981\u5019\u9009\u836f\u7269 PTX-100 \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u7528\u4e8e\u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624 (TCL)\uff0c\u5305\u62ec\u76ae\u80a4 TCL (CTCL) ).\" \/>\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=\"Prescient Therapeutics \u83b7\u5f97 FDA \u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624\u7684 PTX-100 \u5b64\u513f\u836f\u7269\u5730\u4f4d\" \/>\n<meta property=\"og:description\" content=\"\u4e34\u5e8a\u9636\u6bb5\u80bf\u7624\u5b66\u516c\u53f8 Prescient Therapeutics (ASX: PTX) \u7684\u4e3b\u8981\u5019\u9009\u836f\u7269 PTX-100 \u5df2\u83b7\u5f97\u7f8e\u56fd\u98df\u54c1\u548c\u836f\u7269\u7ba1\u7406\u5c40 (FDA) \u7684\u5b64\u513f\u836f\u8d44\u683c\u8ba4\u5b9a\uff0c\u7528\u4e8e\u6cbb\u7597 T \u7ec6\u80de\u6dcb\u5df4\u7624 (TCL)\uff0c\u5305\u62ec\u76ae\u80a4 TCL (CTCL) ).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/smallcapscn.x5view.co\/prescient-therapeutics-fda-orphan-drug-status-ptx-100-treat-t-cell-lymphomas\/\" \/>\n<meta property=\"og:site_name\" content=\"smallcapsCN\" \/>\n<meta property=\"article:published_time\" content=\"2023-03-09T01:19:46+00:00\" 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