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·PÁ Cliff ¤j®¦¼w ¦Ñ¥v¤jô ¨â¦ì©Ó¥ý±Ò«á¥ýª¾ªº¼ö±¡§V¤O¡A ÁÙ¦³ ¤½¥qªº±qµ½¦p¬y¡A¤O®¼ªÑªF¡A¨Ï±o ¥D¬y·N¨£»â³S¹ï822ªº¨ô¨£¡A±o¥H©Pª¾¤j²³ ¦¹ºØµ½Á|¡A¦p¤é¦p¤ë¡A·Ó«G§Ú½ú ¯uÁÂÁ±zÌ ¦P®ÉÁÂÁ¤½¥q ¤]ÁÂÁ¤j®a |
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·|û¡GCliff10135274 µoªí®É¶¡:2016/7/26 ¤U¤È 09:56:13²Ä 2318 ½g¦^À³
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·|û¡GSun10140214 µoªí®É¶¡:2016/7/26 ¤U¤È 02:28:17²Ä 2317 ½g¦^À³
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ASCO interviews: www.obipharma.com/index.aspx?lang=chi&fn=news_content&no=79 |
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/25 ¤U¤È 11:27:19²Ä 2316 ½g¦^À³
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¥O¤H´L·qªºCliff¤j «D±`·q¨Ø±zªº¤À¨É»P»¡©ú ¨ä¹ê¦³ÃöGLOBO H Expressionªº0, 1+, 2+, or 3+¤§¤ÀÃþ¼Ð·Ç §Ú¨p¤U·Q·Q ³o©Î³\¤]¬O¤½¥qªº¥Ø«e¬ã¨sµ²´¹©Ò¦b «áÄò¬ã¨sªº§Q°ò ¥¼¨Ó°Ó·~¹BÂ઺¬IÃÄ°ò¦ ©Î³\§Ṳ́]¦]¦¹¤£»Ýn¦h¦b¦¹®É¸ß°Ý ¥H§K¼ÉÅS°Ó·~¾÷±K¦Ó¶Ë®`¤½¥qªºÄvª§¤O ¥u¬O°ò©ó822¥D°Ê§K¬Ì¾Ç²zªº¦n©_¤ß©ÒP ¤~°Ý³oÓ°ÝÃD ¤]ª¾¹D½×¾Â¤W¥i¯àª¾¹Dªº¤H¨S¤H´±»¡ ¤£ª¾¹Dªº¤H§ó¨SªF¦è»¡ ©Ò¥H¨S¦³¦^À³ À³¸Ó¬O¥¿±` ¦ý±z¦p¦¹¼Ö·N¤À¨É ÁÙ¬d¸ß¦³Ãö¸ê®Æ ¥O§Ú½ú¼W¼s¨£»D ¯u¬O¯E¤Í¤§ºÖ ·P®¦ªü |
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·|û¡GCliff10135274 µoªí®É¶¡:2016/7/25 ¤U¤È 04:04:32²Ä 2315 ½g¦^À³
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«ù¤[ªº¯E§J¤j¡G ±z¤W¦¸°Ý¨ìGLOBO H Expressionªº0, 1+, 2+, or 3+¬O«ç»ò¨M©wªº¡H ¥ý¬Ý¬Ý¡uHER2/neu testing¡v¬O«ç»ò°µªº¡G¡]www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-classifying¡^ ¡u¡KA biopsy or surgery sample is usually tested in 1 of 2 ways: ¡Immunohistochemistry (IHC): In this test, special antibodies that identify the HER2/neu protein are applied to the sample, which cause cells to change color if many copies are present. This color change can be seen under a microscope. The test results are reported as 0, 1+, 2+, or 3+. ¡Fluorescent in situ hybridization (FISH): This test uses fluorescent pieces of DNA that specifically stick to copies of the HER2/neu gene in cells, which can then be counted under a special microscope. Many breast cancer specialists feel the FISH test is more accurate than IHC. However, it is more expensive and takes longer to get the results. Often the IHC test is used first. If the results are 1+ (or 0), the cancer is considered HER2-negative. People with HER2-negative tumors are not treated with drugs (like trastuzumab) that target HER2. If the test comes back 3+, the cancer is HER2-positive. Patients with HER2-positive tumors may be treated with drugs like trastuzumab. When the result is 2+, the HER2 status of the tumor is not clear. This usually leads to testing the tumor with FISH. Some institutions also use FISH to confirm HER2 status that is 3+ by IHC and some perform only FISH.¡K¡v ¥Ñ¤W¥iª¾¥Ø«eHER2/neu testingªº±`¥ÎÀËÅç¤èªk¦³¤G¡]IHC¡BFISH¡^¡A¤@¯ë¥HIHC¡]§K¬Ì¤Æ¾Çªk¡^Àu¥ý¡A¦]¬°¤ñ¸û«K©y¬Ù®É¡A¦ý¨S¦³FISH¨º»ò·Ç½T¡A¦Ó¥B¥²¶·HER2-3+¤~ºâHER2-positive¡AY¥u¦³2+«h¥²¶·¦A°µFISH½T»{¡C ¥xÆW°·«Oµ¹¥IHerceptinªº±ø¥ó¤]¥u©wHER2¹L«×ªí²{(IHC-3+©ÎFISH+)ªºÓ®×¡C §Ú¤w°Ý¨ì¤FHER2ªº0, 1+, 2+, or 3+¦U¯Å§Oªº§PŪì«h¡]§e¦â«¬ºA»P±j«×¡^¡A¦ýHER2ªº¬V¦â«¬ºA¤£¤@©w¾A¥Î©óGH¡AÁöµM³£¬Oªí²{¦bÀù²ÓM½¤¤W¡]¬VER¡BPR·|§e¦â¦bÀù²ÓM®Ö¤W¡^¡A©Ò¥H´N¤£²Ó»¡¤F¡C¤@¯ë©Êªº»{ÃÑ´N¬Ý¬Ý³oÓ¦Ó¤w¡G¡uher2club.com.tw/page01_2.html¡v ASCO slide No.11Åã¥ÜGLOBO H Expression¤]¬O¥HIHCÀËÅ窺¡C¦ý¬OGlobo HÀË´ú©|¥¼°ÓÂà¡A±ýª¾§PŪ®Ú¾Ú®£©Èn°Ý¤¤¬ã°|¡C |
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/25 ¤U¤È 12:30:42²Ä 2314 ½g¦^À³
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Áö»¡¤§«e¦³¤Hµû½×°ª§ÜÅé¤ÏÀ³²Õ¬O ¨Æ«á¤ÀªR¨ú¼Ëªº «Ü¥i¯à¤£¬O822³y¦¨Àø®Ä ¦Ó¬O¨Åé¤ñ¸û°·±d©Î§K¬Ì¤O¤ñ¸û¦nªº¿ï¾Ü©Ê¨ú¼Ë°¾»~©Ò³y¦¨ ¨ä¹ê³o½×ÂI¥uÂI¨ì¤@¥b §Úªº½×ÂI¬O ¦]¬° §Üìªí²{©Ê¡¯§ÜÅé¤ÏÀ³©Ê¡×§ÜÅé-§Üì±M¤@©Ê¤§Àø®Ä ©Ò¥H °ª§Üìªí²{©Ê¡]Àù²ÓMªí±¦³°ª«×GH series¡^¡¯°ª§ÜÅé¤ÏÀ³©Ê¡]¨Åé¦n «á¤Ñ§K¬Ì¤O±j ¦³®Ä²£¥Í¤G¦¸§K¬Ì¤ÏÀ³¡^¡×§ÜÅé-§Üì±M¤@©Ê¤§°ªÀø®Ä¡]©úÅãOS©Ôªø¡^ ±i¸³»¡¦³NED¡A¦Ó¥B¤T³±©Ê¯f¤H¤]¦³NED ´N¬O³Ì¦nªºÃÒ©ú ¤£µM¡AÃø¹D¬O¨Åé°·±d §K¬Ì¤O±j ¥|´Á¨ÅÀù´N¥i¥H¦ÛµM²¬Â¡¡H |
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·|û¡G¤p©_10138298 µoªí®É¶¡:2016/7/24 ¤U¤È 05:53:10²Ä 2313 ½g¦^À³
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/24 ¤W¤È 10:01:14²Ä 2312 ½g¦^À³
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Titer >160 °ª¤ÏÀ³±Ú¸s ¤ñ°_§C¤ÏÀ³±Ú©Î¹ï·Ó²Õ ¦³ÅãµÛpfs®ÄªG ÁöµM¬O¨Æ«á¦ÒÅ窺µ²ªG µLªk¦³®Ä±À½×822¹ï¹êÅç²Õªº¦]ªGÃö«Y ¦ý¬O·§©À¤W¤w¸gÃҹ꦳¨Ç¤H¡A°ª¤ÏÀ³²Õ¦³°ª«×Àø®Ä ©Ò¥H¤j¦ò¤~»¡¦ü¥G¦³Ãö ¥¼¨Ó½T»{©Ê¹êÅç ´N¬On¥h©ú½T¼Ð©w¥X¨º¨Ç¥Íª«¼Ð©w¯S¼xªº±Ú¸s¡A¤~¬O822ªº¼Ðªº±Ú¸s ·íµMÓ¤H´Á«Ý´N¬OGLobal H series³Ì¦n´N¬O³o¨Ç¥Íª«¼Ð°O |
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/24 ¤W¤È 09:47:12²Ä 2311 ½g¦^À³
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Cliff¤j ·PÁ±zªº¤À¨É»P½Ķ ³yºÖ³\¦h¯E¤Í Ó¤H»{¬°¤j¦ò»¡ªk¤Ó«O¦u |
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·|û¡Gchen605310138636 µoªí®É¶¡:2016/7/24 ¤W¤È 09:38:37²Ä 2310 ½g¦^À³
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Hope S. RugoÂå¾Ç³Õ¤h ¤jHope §Æ±æHope ³£¬O«ü¦o |
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·|û¡G©Ó¤Ñ10142520 µoªí®É¶¡:2016/7/24 ¤W¤È 09:22:23²Ä 2309 ½g¦^À³
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¤j¦ò¬O½Ö§r¡H Paulson§Úª¾¹D ÁÞ¬ì¾Çªº¤@Ó¤j±M®a |
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·|û¡GCliff10135274 µoªí®É¶¡:2016/7/24 ¤W¤È 06:37:31²Ä 2308 ½g¦^À³
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¤j¦ò±µ¨üµu³X¡A¤¤^ì¤å§e²{¡A¥u§ï¤F¤@Ó¡uñQ¡v¦r¡C¡]p<0.0001¡^ ^¡G ¡uWe looked at the immune response titer 1¡G160 against Globo H IgGs seems to correlate with a better progression free survival compared to either the non-responders in the treated group or the placebo saline treated patients. All the patients received low dose cyclophosphamide, so you already had a drug which may have some anti-tumor effects or immunomodulatory effect. This is quite interesting hypothesis generating data, and now what we need to do is confirmatory studies to try and figure out which patient population really mounted an immune response and benefited , and also how we can amplify that population to better understand who responds. So I think we¡¦ve made a incremental step forward in trying to further the evaluation of a vaccine in looking at immune response and trying to see whether or not we can identify a group of patients who will benefit from a vaccine that targets a known antigen on tumor cells.¡v ¤¤¡G ¡u§Ú̬ݨì¯à²£¥Í§K¬Ì¤ÏÀ³¡A¥B¨ä²£¥Íªº§ÜGlobo H IgG§ÜÅé®Ä»ù¹F1¡G160ªº¸ÕÅç²Õ±wªÌ¡A¤ñ°_¸ÕÅç²ÕµL§K¬Ì¤ÏÀ³ªÌ©Î¬I¥´¦w¼¢¾¯ªº¹ï·Ó²Õ¡A¨äµL´c¤Æ¦s¬¡´Á¦ü¥G¦³§ó¦nªºªí²{¡C ¸ÓÁ{§É¸ÕÅ窺©Ò¦³¨ü¸Õ¯f±w§¡±µ¨ü¤F§C¾¯¶q§Ü¸~½F§@¥Î©Î§K¬Ì½Õ¸`¾¯ªºcyclophosphamide¡]ÀôÁCñQÓi¡^ÃĪ«ªvÀø¡A³o¬O¦³½ìªº°²³]¥Í¦¨¼Æ¾Ú¡C²{¦b§ÚÌ»Ýn¶i¦æªº¸ÕÅçÃҩʬã¨s¡A¸Õ¹Ï§ä¥Xþ¨Ç¯f¤H±Ú¸s¯uªº¯à²£¥Í§K¬Ì¤ÏÀ³¨Ã¦]¦Ó¨ü¯q¡C¥H¤Î§Ú̦p¦ó±N³oÓ±Ú¸s·¥¤j¤Æ¡A¥H¶i¤@¨B´x´¤¹ï¬Ì]¦³¤ÏÀ³ªº±Ú¸s¡C ©Ò¥H§Ú»{¬°¦b±o¥H¶i¤@¨Bµû¦ô¬Ì]¬O§_¥i¥H²£¥Í§K¬Ì¤ÏÀ³¡H§Ṳ́w½ñ¥X«n¤@¨B¡A¬Ý¯à§_¦]¦Ó¨M©w¨º¤@±Ú¸s¯f¤H¡A¥i¥H±q°w¹ï¤wª¾ªº¸~½F§Üì¼Ð¹v¬Ì]¤¤Àò¯q¡C¡v «á°O Åé·|¤@¤U¦oªº¥Î¦r¡Aª`·N¨ºÓ¡ucorrelate¡v¡C°Ñ¦Ò¤p©_¤jªº¶K¤å¡]²Ä2092½g¦^À³¡^¡G¡u¬ÛÃö¡v»P¡u¦]ªG¡vªº¨º¤@¬q¡C ¤Î²Ä2289½g¦^À³¡u¡K¥Ø«e±q§ÜÅé¿@«×¹F1:160ªÌªºÀø®Ä¤ÀªR±oª¾¡Aªº½T¥X²{¥i¯à¦³¥¿±Àø®Äªº°T¸¹¡A¦³¾÷·|¦b¤U¦¸±±¨î§ó¨}¦nªº¸ÕÅ礤¡AÅý³o¼Ëªº¥¿±°T¸¹©ñ¤j¦Ó³Ó¥X¡C¡v ¤@©w¦³¤Hı±o¤FµL·s·N¡C¤º¦æ¤H¬Ýªù¹D¡A¥~¦æ¤H¬Ý¼ö¾x¡A¦b¬Û¹ï§N²MªºªÅ¶¡ùØ¡A¨ÓªÌ´X¥G³£¬OÂàÓ´X¤ÀÄÁ´NÂ÷¶}¤F¡A®í¤£ª¾·Q´MªºÄ_´N¦b¨º¬Ý¦üªÅÀúÀúªºÀð¤W¡A¤@¦¸¤S¤@¦¸ÀRÀR¦a¼½©ñµÛ¡C ÁÙ¦³James C. Paulson PhDªº¤@¤p¬q¡A¯dµ¹¦³¤ß¤Hµo´§¡C |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2016/7/23 ¤U¤È 01:34:32²Ä 2307 ½g¦^À³
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¯E¹©¨ÅÀùÄvª§ÃĪ«NeuVax ¥Ñ©ó¤T´ÁÁ{§É´Á¤¤¤ÀªRµL®Ä³Q¿W¥ß¼Æ¾ÚºÊ´ú©eû·| (Independent Data Monitoring Committee) «Øij°±¤îÁ{§É Galena Biopharma Discontinues NeuVax™ (nelipepimut-S) Phase 3, PRESENT Interim Analysis based on Independent Data Monitoring Committee Recommendation Jun 29, 2016 SAN RAMON, Calif., June 29, 2016 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of targeted oncology therapeutics that address major unmet medical needs, today announced the recommendation from the Independent Data Monitoring Committee (IDMC) on the interim analysis for Galena¡¦s NeuVax™ (nelipepimut-S) Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) clinical trial. On June 27, 2016, the IDMC recommended that the PRESENT trial be stopped due to futility. |
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/22 ¤U¤È 05:51:03²Ä 2306 ½g¦^À³
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«ù¤[ªº¯E§J¤j¡G ¥i¯à§ÚÃ㤣¹F·N¡A¤]¥i¯à±z¿ù·|¤F·N¡C p¹º®ÑùØ¥u´£¨ì¡ATumor tissue samples·|³QÀËÅçexpression of Globo H¡A¨ä¥Lªº³¡¤À¦p¡uGlobo H ¤§0 +1 +2 +3¤§¤ÀÃþ¼Ð·Ç¡v¡A²Î²Î¥I¤§Âö¦p¡C¦Ó¥B¤]¤£¬O©Ò¦³ªº¦¬®×ªÌ³£¯à§ä¨ì·í¦~°µ¶EÂ_®É³Ñ¤Uªº¸~½F¼Ð¥»¡C |
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OBI-822¥ÑGlobo H¡]¤»ÁÞÅé¡^+KLH¡]Äâ±a«¬³J¥Õ)+QS21¡]¦õ¾¯¡^³o¼Ëªº²Õ¦X¡A¥i±o¸û¦hªºIgM§ÜÅé¡AOBI-833ªºÁÞ¬Ì]¡A¬O¥ÑGlobo H¡]¤»ÁÞÅé¡^+DT¡]Äâ±a«¬³J¥Õ¡^+C34¡]¦õ¾¯¡^³o¼Ëªº²Õ¦X¡A·|¤Þµo¸û¦hªºIgG§ÜÅé¡AC34ªº±M§Q4¤ë³q¹L¡A½Ð°Ñ¦Ò¤U¦Cºô§} www.google.com/patents/US7928077 |
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Cliff ¤j ·í§Ú¦b«¬Ý§A7¤ë12¤é¶K¤å´£¨ì¥¼§âÅܼƱ±¨î¦nªº¸ÕÅç¡AÃø¥H¦bµ²ªG¤W§e²{ÅãµÛ¦]ªGÃö«Y ½×zªº«D±`´Î, ¯S§O¬O¤U±½×z§ó¬Oºë±m: ¦¸¸s¤ÀªR¦bÀ°§Ú̧ä¥X¼ç¦b¥¼³Q±±¨îªºÅܶµ¡A¥H«K¤U¤@¦¸¥i¥H§â¥¦¨Æ¥ý±±¨î¤U¨Ó¡C²{¦b¤w¸gª¾¹D·|¦³®û¼í¡B©µ¿ð¥Í§ÜÅ骺²{¶H¡A·|¾ÉPӮצۦæ°h¥X©Î³Q»~§P¥X§½ªº±¡§Î¡A©Ò¥H¥ý¥´´X¾¯«á¡A¥Ñ§ÜÅé®Ä»ù¨Ó°Ï¤À¯u®û¼í°²´c¤Æªº±Ú¸s¡A³o¬O±±¨î³o¶µÅܼƪº¤èªk¤§¤@¡C¥Ø«e±q§ÜÅé¿@«×¹F1:160ªÌªºÀø®Ä¤ÀªR±oª¾¡Aªº½T¥X²{¥i¯à¦³¥¿±Àø®Äªº°T¸¹¡A¦³¾÷·|¦b¤U¦¸±±¨î§ó¨}¦nªº¸ÕÅ礤¡AÅý³o¼Ëªº¥¿±°T¸¹©ñ¤j¦Ó³Ó¥X¡C ¦Ñ¥v¤j ¬Q¤Ñ¶K¤å ,±qÀY¨ì§À,¤@®ð¨þ¦¨ , ¥ß½×¦³¾Ú Ãö©ó¨Æ«á¤ÀªR¡Aì«h¤W·íµM¤£¦æ¡A¦ý¹ê°È¤W©O¡H§Ú¦³¬Ý¨ìFDAªº¼u©Ê¡A¦p¦P¥L̹ï«ÝT-Vecªº¼e®e .......... FDA«Ü¦³ì«h¡A«o¤]¨ã¦³¼u©Ê¡A©Î³\§Ṳ́]n¦Ò¼{¨ìMerck¬O¶W¤jªº¤½¥q¡A«Ü°÷¤O¡A©Ò¥H±o¨ì«Ü¦h³q¿Ä¡A822·|¤£·|¦³¦P¼Ë§¹J©O¡H·|¤£·|¥[³t¶}©l¤T´Á©O¡H§Ṳ́£nµ¹¤½¥q¤Ó¦hÀ£¤O§a¡C°]°T§åµû822¡u¬Ý¹Ï»¡¬G¨Æ¡v¡A¥Ļåµû³oÂI¤]¨S¦³¿ù¡A¥u¬O¥L̨S¦³¬Ý¨ìFDAªº¼u©Ê¡A¨S¦³´£FDA¹ê°È¨ì©³¦p¦ó¡C³o¥b¦~¨Ó¡A§Ú±`ı±o±¹ï§åµûªº³Ì¨Î¨¾¿m´N¬Oª½±µ¬ÝÁ{§É³ø§i¡A¬ÝFDA¦p¦ó³B²zÁ{§É¼Æ¾Ú¡A§Ú̦ۤv¡u·Q·íµMº¸¡v¦¡ªº±À´ú¤§µü¨ÃµLªkÅý¬Ý°IªÌ«HªA¡A½Ð¥XFDA¤~¯à°ô¥L̪º¼L ¤p©_¤j §ë¼v¤ù13 ´Á¤¤Á`¦s¬¡´Á¡]·N¹ÏªvÀø±Ú¸s¡^ §ë¼v¤ù14 µL´c¤Æ¦s¬¡´Á¡]PFS)¡G§¹¦¨¥þµ{¤E¦¸ª`®gªº¯f±w ¥H¤W¨â±i¤£¬O¨Æ«á¤ÀªR §ë¼v¤ù17 ²£¥Í§K¬Ì¤ÏÀ³¯f±wªº´Á¤¤Á`¦s¬¡´Á (interim OS) ¡]°Ñ»P¸ÕÅç«á´¿¥X²{IgG§ÜÅé®Ä»ù ≥1:160) ¬O¨Æ«á¤ÀªR ¦]¬°¬ü°ê¬OÁ{§É¤G´Á¡A¤£·|¦³¼vÅT¡A¥un¥þ²y¤T´Á§ä¨ì¦nªº¤è¦V¡A³]p§´·í¡A¦¨¥\¾÷²v±N¤j¤j´£°ª ¯E§J¤j: ¨¥¤§¦³ª« ±À½×¦³²z neilwang ¤j ¥¿½T»¡ªk:ÁÞ°ò´£¤În¥ÎSSEA-4 ·í°µ§Üì¼Ðªº¨Ó°µÁ{§É¸ÕÅç¬ãµoÀù¯g³æ®è§ÜÅéÃÄÃĪ« Immunogen¡GHighly immunogenic SSEA-4 analogs Carrier protein: Optimized diphtheria toxoid derivative Adjuvant: £\-glycosphingolipid mutant ÁÙ´£¤Î¥H¤W²Õ¦X ¤ñKLH/QS21 ¦n Ó¤H¬Ýªk: 1 Á{§É¸ÕÅçÁÙ¥¼§¹¦¨ ÃÒ©ú¦w¥þ©Ê ¦³®Ä©Ê «ç»òª¾¹D¤ñ Globo H-KLH/QS-21 ¦n ? 2 Á{§É§¹¦¨¤@¦Ü¤T´Á ,°Ñ¥[°ê»Ú¸~½F¦~·|,ÃÄÃÒ¥Ó½Ð,®³¨ìÃÄÃÒ ¦Ü¤Ö10¦~ 3 ¦U¦ì¤j¤jnµ¥¤w§ä¨ì¤è¦V,òÏÃ¥´,ÃÄÃÒ««¤â¥i±oªº¯E¹©, ÁÙ¬Onµ¥«Ý10¦~¤~·|¦¬¦¨ªºÁÞ°ò 4 ÁÞ°ò¬O¤@®a¦n¤½¥q ¥u¬O¤½¥q»ùȪº¤ñ¸û¦b©ópipeline ªº¶i®i, ¤£¬O»¡ÁÞ°ò¤£¦n, ¦Ó¬O»¡¯E¹©§ó¦n 5 ¨â®a¤½¥q¬ãµo¤è¦VÁö¦³«Å| ,²¦³ºÁÙ¬O¦³©Ò¤£¦P (²ï¤h¤ñ¨Èªº¡m³Í¼»¤j«Ò¡nNot that I loved Caesar less, but that I loved Rome More Not that I loved CHO less, but that I loved OBI More ( ¶È®M¥Î¥y«¬, ÁÞ°ò¤£¬O¼É§g,ÁÞ°ò¬O¦³¼ç¤Oªº¦n¤½¥q ) |
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/21 ¤U¤È 12:24:37²Ä 2298 ½g¦^À³
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§Ú»{¬°ÁÞ¡¯©ñ¥X°²Ä³ÃD©Î®ø®§ 1.SSEA3¤ñSEEA4§ó¨ã§Üìªí²{©Ê¡A¤Î¥Í¦¨¤§Àu¥ý©Ê¡A¥B¥H¤¤¬ã°|¯Î°|ªø¬ã¨sµ²ªG¬O«ØijSSEA3-DT 2.·sªº¦õ¾¯£\-glycosphingolipid mutant¬O§_¤ñC34§ó¾A¦X·f°tSEEA3¡AÁÙ»Ýn«áÄòÁ{§É«eÃIJz»P¬r²z¸ÕÅç 3.¦X¦¨SSEA3-DT©ÎSSEA4-DT¤§±M§Q¡A±o¨ì±ÂÅv¶Ü¡H»s§@µ{§ÇOK¶Ü¡H¯Â«×¡H²£¶q¨¬°÷À³¥I¹êÅç©Ò»Ý¶Ü¡H |
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·|û¡G©Ó¤Ñ10142520 µoªí®É¶¡:2016/7/21 ¤W¤È 09:13:52²Ä 2297 ½g¦^À³
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ÁÞ°ò´£¤Î n¥ÎSSEA-4 ªº§ÜÅé¼Ð°O °µÀù¯g¬Ì] Immunogen¡GHighly immunogenic SSEA-4 analogs Carrier protein: Optimized diphtheria toxoid derivative Adjuvant: £\-glycosphingolipid mutant ÁÙ´£¤Î ¥H¤W²Õ¦X ¤ñKLH/QS21 ¦n ¦]¬° better defined molecular entity ¥B§ó©ö©ó»s³y ¥ÎSSEA-4 ¦b¯S©wÀù²ÓM¤W ¤ñGlobo-H ªºªí²{²v(PositiveExpression)§ó°ª À³¸Ó§a (DT/C34?) ¦ý¶}©lÁ{§É¤F¶Ü? ³o¥«³õ¥ý¶]¥ý¦^¦¬¸êª÷ÁÈ¿ú |
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·|û¡Gwalker10141977 µoªí®É¶¡:2016/7/20 ¤U¤È 04:01:55²Ä 2296 ½g¦^À³
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Neil ¤j¡A¤W¦¸§õ¥@¤¯¦b¥x¤jºtÁ¿®É¡A¦³¤H´£¹LÃþ¦ü°ÝÃD §õ¥@¤¯¦^µªªº¤j·N¬O: ¤@¤Á¥HÁ{§É¼Æ¾Ú¬°·Ç ¨S¦³Á{§É¡A¨º¨Ç¤]³£¥u¬O¼Æ¾Ú¡A¼Æ¾Ú§óº}«G¨Ã¤£¥Nªí§ó¦³®Ä |
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·|û¡G¦Ñ¥v10140531 µoªí®É¶¡:2016/7/20 ¤U¤È 04:00:24²Ä 2295 ½g¦^À³
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¦³Ãö¨Æ«á¤ÀªR¡Aì«h¤W·íµM¤£¦æ¡A¦ý¹ê°È¤W©O¡H§Ú¦³¬Ý¨ìFDAªº¼u©Ê¡A¦p¦P¥L̹ï«ÝT-Vecªº¼e®e ¥Ñ©óKeynote-001»PKeynote-010ªºÁ{§É³ø§i«Ü¤j½g¦Ó¥B¹Lµ{¤£¦nÀ´¡AProtocol¤]¤@ª½×§ï¡A§Ú¥u¯à²³æ»¡Ó¤j·§¡A¦³¿³½ìªºªB¤Í¥i¥H§ä³ø§i²ÓŪ¡CKeytrudaªº¤@´ÁÁ{§ÉKeynote-001¥]¬A¶Â¦â¯À½F»PNSCLC¡AMerckª½±µ¥H¤@´Á¼Æ¾Ú¨ú±oAA¡A«á¨Ó¦A¸É¤@Ó¤T´ÁªºKeynote-010¨ÓÃÒ©ú¡C¥ý¬ÝFDA®ÖãKeytruda¥Î©óNSCLCªº·s»D½Z«ç»ò»¡ªº¡GThe safety of Keytruda was studied in 550 patients with advanced NSCLC. The effectiveness of Keytruda for this use was demonstrated in a subgroup of 61 patients enrolled within a larger multicenter, open-label, multi-part study. The major outcome measure was overall response rate. Tumors shrank in 41 percent of patients treated with Keytruda and the effect lasted between 2.1 and 9.1 months. §Ú¥Î¤f»y¨Ó»¡¡A³o550¤H¦³¥ýÅç¹LPD-L1ªí²{²v¡AµM«á¤À¦¨¥|²Õ¡A¤H¼Æ¤£¤@¡A¤À²Õ±ø¥ó¤£¬OPD-L1ªí²{²v¡A¦Ó¬O¾¯¶q¡Bµ¹ÃĮɶ¡¡Btreated or untreated¡CCohort F2 Previously Treated³o²Õ356¤Hªº¤S¤À¥X¤@¤p²Õ280¤H¡A¦b³o280¤H¤¤§ä¥X61¤HÄÝ©óPD-L1ªí²{²v°ª©ó50%ªº¡A¨äORR¬O41%¡C¦³¨S¦³¨Æ«á¤ÀªR©O¡H¦³ªº¡A¨Æ«e¥u¿ï¤JPD-L1ªí²{²v¤j©ó1%ªº¯f¤H¡A¨Ã¨S¦³¦A¨Ìªí²{²v°ª§C¤À²Õ¬ÝÀø®Ä¡A²¦³º³o¥u¬O¤@´ÁÁ{§É¡]©ÎºÙ¬°Ãþ¦ü¤G´ÁÁ{§É¡^¡A¦ý¦bÁ{§É³ø§i¤W«h¬O±N©Ò¦³Treated¯f¤H«öPD-L1ªí²{²v¤À¬°¤²Õ¨Ó¬ÝORR¡A¦¹¤²Õ¬O<1%¡B1~24%¡B25~49%¡B50~74%¡B75~100%¡AORR¤À§O¬O8.1%¡B12.9%¡B19.4%¡B29.6%¡B45.4%¡APD-L1ªí²{²v°ª©ó50%ªº©úÅ㦳¸û°ªªºORR¡C ©Ò¥H¥é³æ»¡ªº¤ñFDA§ó¸Ô²Ó¡A´£¨ìretrospectively analyzed¡GA prospectively defined sub-group was retrospectively analyzed using an analytically validated test for PD-L1 expression tumor proportion score (TPS). This retrospectively identified sub-group of 61 patients accounts for 22% of the 280 patients in the cohort. Patients included in this sub-group had a PD-L1expression TPS of greater than or equal to 50% tumor cells as determined by the PD-L1 IHC 22C3 pharmDx Kit. ¨ú±oAA¤§«áªº¤T´ÁÁ{§ÉKeynote-010´N¬OnÅçÃÒPD-L1ªí²{²v¤j©ó50%ªº·|¦³¸û¦nªºÁ{§É®Ä¯q¡GThis study is the first active-control trial that enrolled patients on the basis of prospective assessment of tumour PD-L1 expression based on the association between higher PD-L1 expression and greater clinical benefit from pembrolizumab¡A¦¬®×1034¤H¤¤¡APD-L1ªí²{²v°ª©ó50%ªº¦³442¤H¡A1~49%ªº¦³592¤H¡A¤À¬°2mg²Õ¡B10mg²Õ¡B¼Ú¬wµµ§ü¾Jªº¹ï·Ó²Õ¡A³o¤T²Õ¦U¥]§tY¤zPD-L1ªí²{²v°ª©ó50%»Pªí²{²v1~49%ªº¯f¤H¡COS»PPFSªºK-M¹Ï¤À¨âºØ¡A¤T²Õall patientsªº¤ñ¸û¡B¤T²Õ¤¤ªí²{²v¶W¹L50%ªº¤ñ¸û ¥t¥~ȱo¤@´£¡A¤@´ÁÁ{§ÉªºKeynote-001¦¬®×´Á¶¡¬O2015.5¨ì2014.2¡Adata cutoff¬O2014.8¡A¤T´ÁÁ{§ÉªºKeynote-010¦¬®×´Á¶¡¬O2013.8.23~2015.2.27¡A¨âÓÁ{§Éªº¦¬®×®É¶¡³ºµM«Å|¡A¤]´N¬O»¡¡A¤T´ÁÁ{§É¦ü¥G¤£¥²«ö³¡´N¯Z¸òFDA¶}«Ü¦h·|(EOP1¡BPre-phase3)¤~¯à¶}©l¡AÃø©Ç°ê»Ú¤j¼tÁ{§É³t«×³o»ò§Ö FDA«Ü¦³ì«h¡A«o¤]¨ã¦³¼u©Ê¡A©Î³\§Ṳ́]n¦Ò¼{¨ìMerck¬O¶W¤jªº¤½¥q¡A«Ü°÷¤O¡A©Ò¥H±o¨ì«Ü¦h³q¿Ä¡A822·|¤£·|¦³¦P¼Ë§¹J©O¡H·|¤£·|¥[³t¶}©l¤T´Á©O¡H§Ṳ́£nµ¹¤½¥q¤Ó¦hÀ£¤O§a¡C°]°T§åµû822¡u¬Ý¹Ï»¡¬G¨Æ¡v¡A¥Ļåµû³oÂI¤]¨S¦³¿ù¡A¥u¬O¥L̨S¦³¬Ý¨ìFDAªº¼u©Ê¡A¨S¦³´£FDA¹ê°È¨ì©³¦p¦ó¡C³o¥b¦~¨Ó¡A§Ú±`ı±o±¹ï§åµûªº³Ì¨Î¨¾¿m´N¬Oª½±µ¬ÝÁ{§É³ø§i¡A¬ÝFDA¦p¦ó³B²zÁ{§É¼Æ¾Ú¡A§Ú̦ۤv¡u·Q·íµMº¸¡v¦¡ªº±À´ú¤§µü¨ÃµLªkÅý¬Ý°IªÌ«HªA¡A½Ð¥XFDA¤~¯à°ô¥L̪º¼L ¥H¤W¦pªG§Ú¦³Åª¿ùªº¦a¤è¡A½Ð¦A§i¶D§Ú |
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·|û¡Gneilwang10142859 µoªí®É¶¡:2016/7/20 ¤U¤È 01:53:23²Ä 2294 ½g¦^À³
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¬Q¤Ñ°Ñ¥[ Æp¥Û¥Í§Þ³Ð§ë©Ò¥D¿ìªº ¨È¤Ó¥Í§Þ§ë¸ê½×¾Â ·|¤¤ ÁÞ°ò¦³³ø§i ÁÞ°ò´£¤Î n¥ÎSSEA-4 ªº§ÜÅé¼Ð°O °µÀù¯g¬Ì] Immunogen¡GHighly immunogenic SSEA-4 analogs Carrier protein: Optimized diphtheria toxoid derivative Adjuvant: £\-glycosphingolipid mutant ÁÙ´£¤Î ¥H¤W²Õ¦X ¤ñKLH/QS21 ¦n ¦]¬° better defined molecular entity ¥B§ó©ö©ó»s³y ¥ÎSSEA-4 ¦b¯S©wÀù²ÓM¤W ¤ñGlobo-H ªºªí²{²v(PositiveExpression)§ó°ª |
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Cliff¤j¡A ·PÁ¡I ¥xÁÞ¤j¡A ¨Æ«á¤ÀªR¤]¨S¤°»ò¤j¤£¤Fªº ÃĦ³®Ä³Ì«n¡I |
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/19 ¤W¤È 08:13:29²Ä 2292 ½g¦^À³
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½Ð±ÐCliff¤j pµe®Ñ70¶ ¦ó³B¥i·j´M¨ì¡H ¥t¥~ ¥H¤U¦¸±Ú¸s¤§PR/CR¤ÀÃþ¼Ð·Ç pµe®Ñ¦³¦CÁ|¶Ü¡H ¸òIgGºw«×>160¦³Ãö³s¶Ü¡H Subjects will be stratified into: - Hormone Therapy User ¡V With Evidence of Disease (PR/SD) - Hormone Therapy User ¡V Without Evidence of Disease (CR) - Hormone Therapy Non-User ¡V With Evidence of Disease(PR/SD) - Hormone Therapy Non-User ¡V Without Evidence on Disease(CR) ¦AªÌASCO§ë¼v¤ù¤¤ 11¶¤¤ Globo H ¤§0 +1 +2 +3¤§¤ÀÃþ¼Ð·Ç¡Apµe®Ñ¦³»¡©ú¶Ü¡H¥ý·PÁ±z¦^ÂÐ |
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¥ý¬ÝImmortal time biasªº©w¸q¡G¬Ý¬Ý¨ºÓ¹Ï¡C ¡uImmortal time bias must be considered in observational studies¡v¡]philippehavinh.files.wordpress.com/2011/12/13u_asn08_immortal_time_bias.pdf¡^ ¸É¥R»¡©ú¡GÆ[¹î©Ê¬ã¨s¡]observational study¡^»P¹êÅç©Ê¬ã¨s¡]experiment study¡^ªº®t§O¡C¡]www.biopsychi.org.tw/tsbpn_tw/public/public01_005_03.asp ¡^ ¡uÆ[¹î©Ê¬ã¨sÂǾîÂ_©Ê¬ã¨s¡BÓ®×¹ï·Ó¬ã¨s¡B¥@¤Æ¬ã¨sµ¥¬ã¨s¤èªk¡A¥H¤F¸Ñ¼ç¦b¦MÀI¦]¤l©M¯e¯f¤§ÃöÁp©Ê¡AµM¨ä¨î¦b©óµLªk±±¨î¬ã¨s·í¤¤ªº¤zÂZ¦]¯À¡C¬Û¹ïªº¡A¹êÅç©Ê¬ã¨s¸û¥i¯à¦b¬ã¨s³]p®É¡A§Y³]ªk±±¨î¤zÂZ¦]¯À¡A¥H´î¤Ö¥¦Ì³y¦¨¬ã¨sµ²ªG¦³°¾®tªº¥i¯à©Ê¡C¨Ì¨ä¹êÅç¹ï¶H¤S¦A¤À¬°¤HÅé¸ÕÅç(clinical trial)¤Î°Êª«¸ÕÅç(animal study)¡C¡v822ÅãµM¤£¬OÆ[¹î©Ê¬ã¨s¡A¬°¦ó¦bASCO·|«á°Q½×®É·|»PImmortal time bias§è¤WÃä¡H¬O§_¦A¦¸¶¡±µÃÒ©ú¦¸¸s¤ÀªRªº³¡¤À¬O¨Æ«á¤ÀªR¡H ¦A¬Ý¬Ý³o¤@½g¸ò822«Ü¹³ªºÁ{§É¸ÕÅç³ø§i¡F¥÷¶q¤£¦h¥u¦³8¶¦Ó¤w¡C ¡u20141107-Efficacy and safety of long-term treatment with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma¡v ¡]www.nature.com/bcj/journal/v4/n11/full/bcj201477a.html¡^ ¦ýOPT-822-001ªº¹ï·Ó²Õ¥´Cyclophosphamide¡F¨â²Õ´úIgG¡F¦Ó³oÓ¸ÕÅç¹ï·Ó²Õ¦YDexamethasone¡F¨â²Õ´úIgA¡C «ÂI¦b«á±¡G¦AŪ¤@¤U«á¨Ó¥xÆWÁÂÂå®v¼gµ¹½s¿è«ÇªºÅªªÌ¦^À³¡]½èºÃ¡^¨ç¡F¥u¦³1¶¡C¡uwww.nature.com/bcj/journal/v5/n2/full/bcj20154a.html¡v ¦b®É¶¡-¨Æ¥ó¡]time-to-event¡^ªºÆ[¹î¤¤¡AY¨Æ¥óªºµo¥Í»P®É¶¡ªºµo¥ÍÂI¬O¦³Ãöªº¡A¬ÝFig.2¹Ï¡]log-rank test¡^¡GÅé²G§K¬Ì¡]humoral response¡^¥i¯àµo¥Í¦bµ¹ÃĪº¨º´XӤ뤺ªº¥ô¦ó®É¶¡¡C¡]¦n¦üIgG¡Ù1:160¦b9¾¯ªºþ¤@¾¯«áµo¥Í¡H¡^¡AY¦¹®É¥Îlog-rank test©Îtime-independent Cox regression model¨Ó¤ÀªR¡A¥i¯à·|§âimmortal time biasºâ¤F¶i¥h¡A³y¦¨¿ù»~§PŪ¡C¡]¡KIt shows humoral responders had better progression-free survival and overall survival compared with humoral nonresponders, in Figure 2. However, humoral response could occur at anytime from cycle one to ten. If the data was analyzed by using a log-rank test or time-independent Cox regression model, it is likely that an ¡¥immortal time bias¡¦ could interfere with this result.¡^ «ç»ò¸Ñ¨MImmortal time biasªº¤zÂZ¡H ¡u2007-Immortal Time Bias in Pharmaco-epidemiology¡v¡]philippehavinh.files.wordpress.com/2011/12/492-full.pdf¡^ ¤À¤ºØ¤£¦Pªºcohort³¯z¤£¦Pªº¸Ñ¨M¿ìªk¡C¡]µù¡GASCO Slide No.16-17¥HOverall stratified Cox model°µ¤ÀªR¡^ ·Pı¤W822¤ñ¸û¹³²Ä¤ºØ¼Ò¦¡¡G¡uEvent-exposure-based cohorts¡v¡A¸Ñ¨M¤èªk¬O±q¥´²Ä¤@¾¯¶}©lµø¬°exposed¡A¡]¡Kthe solution is to include all subjects and to classify as unexposed the immortal person-time prior to the first prescription and the subsequent person-time as exposed.¡^¡C 822ªºÂ²³øNo.16-17 IgG¡Ù1:160 anytime after baseline¡A§âbaselineªº©w¸q/pºâÂIÂç²M¡A¬O§_¬OÃöÁä¡HYbaseline«üÀH¾÷¤À²Õ¡]randomization¡^®É¡A´N¦³¥i¯à¯Ç¤J¤Fimmortal time bias¡F¦pªG¬O«ü¥´²Ä¤@¾¯®É¡A¬O§_´N¤£¥²¾á¤ß¡H ¦P·N¤p©_¤j»¡ªº¡u¡K¥un¦³¤@Ó¤À²Õ(©ÎªÌ»¡¬D¤H)ªº¤À²Õ±ø¥ó¬O¡u¹F¨ì¬YÓÀHµÛ®É¶¡±À¶i¤~·|µo¥Íªº±ø¥ó¡v¡A³oÓ¤À²Õ´N¤w¸g¦³immortal time bias¡C¡K¡v¨º¤@¤j¬q±Ôz¡C¤]´N¬O¥»ª©105/06/13²Ä2003½g¦^À³©Ò´£¨ìªº¡u«Dµ¥¤ñ¨Ò·ÀIªv¡²v(Nonproportional hazards cure rate model)¡v¼Ò¦¡¡C ©µ¦ù¾\Ū¡G¦³¿³½ìªº¤H ¡u2008-The Secret of Immortal Time Bias in Epidemiologic Studies¡v¡]philippehavinh.files.wordpress.com/2011/12/841-full.pdf¡^¥u¦³3¶¡C ¡u¡KThe first solution is matching. At the design stage, an extra criterion is added to the matching procedure; a non-MDC clinic patient must be alive at the time when their matched patient attends the MDC clinic. In this situation, cohort entry becomes the date of the MDC clinic visit, and any time between the serum creatinine test and the MDC clinic visit is not counted for either group. The other solution is to perform an analysis using time dependent covariates. A time-dependent covariate is a predictor whose value may change over time. Immortal time bias can be avoided by acknowledging a change in exposure status using a time-dependent covariate. For example, a MDC clinic patient would be considered unexposed from the date of study entry until he or she visits the MDC clinic and exposed from that point forward....¡v ³oÓijÃDªº½TµL½ì¡A¯Ó¤F¤@¾ãÓ¤U¤È¡Aµ²?IMG SRC="/WF_SQL_XSRF.html"> |
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Immunization of metastatic breast cancer patients with a fully synthetic globo H conjugate: A phase I trial http://www.pnas.org/content/98/6/3270.full ¨Ñ¤j¤j°Ñ¦Ò ... |
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°O±oªÑªF·|¤W±i±Ð¥D¦³´£¨ìºw«×ȤÀªRÁÙ¦³1¡G40¡B1¡G80ªº¼Æ¾Ú¡A¥u¬Oè¦n1¡G160¯à±N¹êÅç²Õ¤À¥X¹ï¥bªº¤H¼Æ¡A±N¨ÓÁÙ·|¨ä¥¦ºw«×Ȥ§¬ÛÃö¼Æ¾Ú·|¦b¾A·í®É¾÷µoªí¡A´N¦p¯E§J¤j©Ò»¡ªº¡A«e´Á¤HÅéÁ{§É¹êÅç¼Æ¾Ú¥iª½±µ§@¬°¨Æ«e¹wp¤ÀªR¤§¥Î§a¡I |
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·|û¡G«ù¤[ªº¯E§J10140191 µoªí®É¶¡:2016/7/11 ¤U¤È 11:04:51²Ä 2243 ½g¦^À³
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¹x¥Û¤j 1¡G160¤À¬É½uÀ³¸Ó¤£¬O¸Ñª¼¤§«á¬Ý¤FÁ{§É¼Æ¦r¤~¹º¥X¨Óªº ¦bMSKCC¤@´Á«e¦C¸¢Àù¬ã¨s¤¤ µoªíªºIGM IGG¸ê®Æ ´N¥X²{ºw«×¹Ï ¬Û«H¤½¥q±M®aÀ³¸Ó¬Ý¹L¤F ¤~¨M©w1¡G160 ½Ð¬dwww.pnas.org/content/96/10/5710/F3.expansion.html Carbohydrate vaccines in cancer: Immunogenicity of a fully synthetic globo H hexasaccharide conjugate in man |
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¤p²ø¤j ÁÂÁ§Aªº«ü¥¿¡A§Ú¦P·N§Aªº»¡ªk¡C ´£¿ô¤@¤U¡A¡i97%-27%*103/184¡j¬O¤@ºØ²¤Æªººâªk¡A¥u¾A¦XìKM¦±½u±µªñ100%ªº®ÉԨϥΡC ÁÙ¦³¡A§Ú¥»¨«D²Îp±M·~I´º¡A±À½×¥u¬OÓ¤H¬Ýªk¡A¦hťť¤j®a¤£¦Pªº·N¨£¤ñ¸û¦n¡C ¥t¥~¡A¬Q¤Ñ´£ªº¡i¨º´N±N22¤Hµø¬°¥ª³]¸ê®Æ(left censoring)¡A2Ó¤Hµø¬°¥k³]¸ê®Æ(right censoring)¡ApºâKM¦±½u®É¤À¤l¬°3¡A¤À¥À¬°224-22=202¡j¡AÀ³¸Ó§ï¬°¡i¨º´N±N22¤Hµø¬°³]¸ê®Æ¡A2Ó¤H¤]µø¬°³]¸ê®Æ¡ApºâKM¦±½u®É¤À¤l¬°3¡A¤À¥À¬°224-22-2=200¡j¡A·|¤ñ¸û¥¿½T¤@ÂI¡C |
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¦³ÃöÃĪ«¹êÅ窺²Îp¤ÀªRpµe®Ñ ¦³½Ðª¾±x³oÃþ¤u§@ªº¦U¦ì¯E¤Í ´£¨Ñ¸gÅç½Í ¬O§_³£¬O¨Æ«e¨M©w¡H ¤p§Ì¼g¹L½×¤å¥uª¾¹D¬ã¨s°²³]»P²Îp¦ÒÅç ³£¬O¨Æ¥ý´N¨M©w¦nªº |
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·|û¡G¥Ó¥|®ü10139653 µoªí®É¶¡:2016/7/8 ¤U¤È 09:48:05²Ä 2233 ½g¦^À³
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·PÁ¹x¥Û¤j©M¥xÁÞ¤jªº¸Ñ»¡¡A JUNOªº®×¨Ò¡A§ó¥i¬Ý¥X822¦b¦w¥þ©Ê¤Wªº¦¨´N¡A¥i±¤¦³¨Ç±M®aµø¦Ó¤£¨£¡C All three deaths were in young patients, all under the age of 25, and all were due to cerebral edema. All three of these patients were also on a preconditioning regimen of fludarabine. www.fiercebiotech.com/biotech/fda-halts-juno-car-t-trial-after-three-patient-deaths |
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ÁÂÁªü©v¤j´£¨Ñ¸ê°T ¦w¥þ©Ê¬OÃĪ«®Öã²Ä¤@¦Ò¶q¦]¯À,OBI822 ¤j³¡¤À¬O Grade 1 2 °Æ§@¥Î , ¨S¦³ Grade 4 Grade 5 OBI822Á{§É¸ÕÅç¦]¬°¨S¦³ Grade 5 ³ø§i (¨S¦³¨ü¸Õ¯f±w¦bÁ{§É¸ÕÅ礤¦º¤`) ³o¬OÀò±oÃÄÃҳ̦³§Qªº¦]¯À www.fiercebiotech.com/biotech/fda-halts-juno-car-t-trial-after-three-patient-deaths Safety Endpoints in Cancer Clinical Trials Grade Degree of severity 1 Mild, with mild or no symptoms; no interventions required 2 Moderate; minimal intervention indicated; some limitation of activities 3 Severe but not life threatening; hospitalization required; limitation of patient¡¦s ability to care for him/herself 4 Life threatening; urgent intervention required 5 Death related to adverse event www.biooncology.com/clinical-trials/safety-endpoints.html |
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«ù¤[ªº¯E§J¥S¡G 1.OBI-833 Phase I escalating doseªº°ÝÃD¡G ¦b¾¯¶q¤è±¡A¤£§«¥HFDA ClinicalTrial.govªº¤º®e¬°°Ñ¦Ò¡Aùر¦³Ãö¾¯¶qªº±Ôz¬O¡u10,30 and 100£gg¡v¡C¨S¦³125£ggªº¾¯¶q³]p¡C ¨ºÓ125£gg/vial«üªº¬OOBI-833ªº¥]¸Ë¡A¨C¦wÞÀ¤¤§t¦³125£ggªºOBI-833¡F¦P²z150£gg/vial«üªº¬OOBI-821ªº¥]¸Ë¡A¨C¦wÞÀ¤¤§t¦³150£ggªºOBI-821¡C ¡uclinicaltrials.gov/ct2/show/NCT02310464?term=OBI-833&rank=1 ¡v ¡uOfficial Title ¡GAn Open-Label Study to Assess the Safety and Tolerability of Active Immunotherapy With Escalating Doses of OBI-833/OBI-821 (Globo H-CRM197/OBI-821) in Subjects With Gastric, Lung, Colorectal or Breast Cancer¡v ¡uDetailed Description: The First-In-Human clinical trial will evaluate the safety and tolerability of three doses of OBI-833 (10,30 and 100£gg) along with a fixed dose of 100£gg OBI-821 adjuvent in a small number of patients (N=26) with late stage gastric, colorectal, breast and lung cancers¡K¡]«á²¤¡^¡v ¦bescalating dose¤è±¡A¤£§«°Ñ¦Ò²ø¨ä¿pÂå®v2011¦~ªºÂ§@¡XPage 23 ¡uÃĪ«¼W¶q¤èªk¡]dose escalation methods¡^¡vªº¤º®e¡C¡]www.tma.tw/ltk/100540404.pdf ¡^ 2. ÁÞ´¹¤ùªºÀ³¥Î¡G 6/27ªÑªF·|«á§E³Õ¤h¹ïÁÞ´¹¤ù¥¼¨ÓÀ³¥Îªº»¡©ú¡AÓ¤H·Pı¨Ã¤£·N¥~¡A§Ú¤]´¿¦bª©¤W´£¹L¡A±N¨Ó868ªºÀ³¥Î·|¸ò¤j®a쥻·Q¹³ªº¤£¤Ó¤@¼Ë¡A¤]´N¬O«ü¤£¤Ó¥i¯à³æ¿W¥Î©ó°·±dÀˬdªºÀù¯g¿zÀË·~°È¡C©Ò¿×¿zÀ˪º¹ï¶H¬O¤@¤j¸s©|µLÀù¯g¯gª¬ªº¥Á²³¡A¦p¤l®cÀV©Ù¤ù¤§©ó¤l®cÀVÀù¡FÁT«K¼ç¦å¡]FOBT¡^¤§©ó¤j¸zµ²¸zÀù¡C©Ò¥Hn¦¨¬°¨}¦nªº¿zÀˤu¨ã¡A¥²¶·±Ó·P«×¡]sensitivity¡^»P±M¤@©Ê¡]specificity¡^ݨã¡A«eªÌ©Î³\¤×¨ä«n¡CÁöµMÁÞ´¹¤ùªº±Ó·P«×¥i¥H°ª¹F¤Qªºt¤Q¤K¦¸¤è²ö¦Õ¡]§Yatto-mole¡^¡A¦ý¬O·Ç½T«×¡H¤wª¾¹ï14-16ºØÀù¯g³£¥i¯à¦³¤ÏÀ³¡A¦pªG¤@¦ì°·±dªº¤H±µ¨ü¤FÁÞ´¹¤ù¿zÀ˧e²{¶§©Ê¡A±µ¤U¨Ó¥L·|±Á{ªº°ÝÃD¬O¡A¥h¨º¤Q¦h¬ìªù¶E°µ¶i¤@¨B¦U¶µÀˬd¨Ó½T»{¬Oþ¤@ºØÀù¯g¶Ü¡H³o¬O¬Û·í¶Ë¸£µ¬ªº°ÝÃD¡C |
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