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«ÂI¦b¤U±³o¤@¥y¸Üªº·N«ä¬O¬Æ»ò¡H ¡uMost patients who need ibalizumab may also need another medication to combine it with. Fortunately, BMS is soon launching their study for their attachment inhibitor which will allow the use of ibalizumab.¡v ¡u¤j³¡¤À»ÝnIbalizumabªº±wªÌ¥i¯à¤]»Ýnµ²¦X¨ä¥LªºÃĪ«¡A©¯¹B¦a¡A¥²ªv§´Ãļt´N§Ön¶}©l¥L̪ºªþµÛ§í¨î¾¯ªº¸ÕÅç¡A¸ÓÃıN¤¹³\¥i¥H¨Ï¥ÎIbalizumab¡C¡v
¥²ªv§´ÃļtªþµÛ§í¨î¾¯BMS-663068¦b2014¦~3¤ëCROI¤W³ø§i¤F¤£¿ùªºPhase IIbµ²ªG¡A¨S¦³«¤jªº°Æ§@¥Î¡A¦b¦¥ý¥X´Áªº·§©À©Ê¸ÕÅ礤Åã¥Ü³æ¥Î8¤ÑÁÙ¥i°¯f¬r¸ü¶q1.2-1.7log¤§¦h¡C ¡]http://news.bms.com/press-release/bristol-myers-squibb-presents-promising-phase-iib-data-novel-investigational-attachmen ¡^ ¡]http://www.hivandhepatitis.com/hiv-treatment/experimental-hiv-drugs/4556-hiv-attachment-inhibitor-bms-663068-shows-good-safety-and-efficacy-in-phase-2b ¡^
HIV¦b·P¬V¤HÃþ±J¥DªºCD4²ÓM®É¡A·|¥ý¥H¨äGP-120µ²¦XCD4±µ¨ü¾¹¡A¦ÓBMS-663068¡]¬O¤@ºØ¤fªAÃÄ¡^·|¥ý»PGP-120µ²¦X¡A³y¦¨GP-120µLªk²£¥ÍÀ³¦³ªºÅܧΨӶi¦æ«áÄòªº·P¬V°Ê§@¡F¨ºIbalizumab¬Oµ²¦X¦bCD4±µ¨ü¾¹ªº²Ä¤GÓ¤À¤l¹Î¤W¡]The 2nd domain¡^¡A§Î¦¨HIV RNAn¶i¤JCD4²ÓM®Éªº¸ô»Ù¡AÁ×§KCD4²ÓM³Q¤J«I¦ÓÅõºÈ§K¬Ì¥\¯à¡C ©Ò¥H¥²ªv§´±µ¤U¨ÓªºPhase III¬On±NIbalizumab¯Ç¤J¸ÕÅç¡H³o¤£¤Ó¥i¯à¡C ¨º»ò¡A¡u¡K¡K, BMS is soon launching their study for their attachment inhibitor which will allow the use of ibalizumab.¡v¬O«ü¦ó¸q¡H¤£¤F¸Ñ¡C
¡uI will post an update once the BMS study is started and I have an update meeting with Taimed to find out more about their study to lead to approval.¡v Nelson¤å¥½»¡¡u¤@¥¹¥²ªv§´Ãļtªº¸ÕÅç¶}©l¡A¥L·|¶K¤å¤W¨Ó¡A¦Ó¥B¥LÁÙ·|¦³·sªº¤¤¸Îªº·|ij·|¶K¤W¨Ó§ó·s¡A¨ºÓ·|ij¥i¥H§ó¤F¸Ñ¥L̪º¸ÕÅ示®e¡A§Q©óÃÄÃÒ®Öã¡C¡v ³oÓ·|ijÀ³¸Ó´N¬O§Ṳ́j®a¦b¼ºµ¥«Ýªº¤¤¸Î»PFDAªº°Q½×·|¡C
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¥ý¯¬¤j®a·s¦~§Ö,¥t¬ü°êThe Bodyºô¯¸ªº¿Ô°Ó±M®aNelson³Ìªñ¦^ÂЦ³ÃöIbalizumab(TMB-355)ªº«H®§¦p¤U,¥Ñ©ó³¡¥÷ÂåÀø±M¦³µü¤£¬O¬Ý±o«ÜÀ´,·Q·Ð½ÐCliff µ¥±M®a¨ÓÀ°¦£µû½×¤Î¸ÑªR,·P®¦!! Response from Mr. Vergel I have good news. Ibalizumab IV has been given an orphan drug designation on Oct 20, 2014 by the FDA, which makes it possible for Taimed to get more funding for the required studies for its eventual approval for patients with few HIV medication options due to multidrug resistance. This is the first time in history that an HIV medication has been granted orphan drug designation. Another piece of good news is that doctors can apply to provide this drug as part of a single patient TIND via this process: Physician Request for an Individual Patient IND under Expanded Access for Non-emergency or Emergency Use Most patients who need ibalizumab may also need another medication to combine it with. Fortunately, BMS is soon launching their study for their attachment inhibitor which will allow the use of ibalizumab. Attachment Inhibitor for HIV-1 Infected Treatment-Experienced Patients More information about ibaluzumab Contact info for Taimed Biologics I will post an update once the BMS study is started and I have an update meeting with Taimed to find out more about their study to lead to approval. Nelson
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(2) GSK744©ó03/2014¨jµoªíÆFªøÃþ°Êª«¸ÕÅ窺µ²ªG¡A¨Ã©ó1Q~2Q14¶i¤J¤£¦P¶¥¬q/©Ê½èªº¤HÅé¸ÕÅç¡C®Ú¾ÚClinicaltrial.gov¡AGSK744¥Ø«e¤´¦bPhase2»PPhase2b¤§Á{§É(µù¤@)¡A¹wpPhase2ªº120¤H©ó05/2015§¹¦¨¦¬®×¡APhase2bªº265¤H«h©ó12/2020§¹¦¨¦¬®×¡A§¹¦¨¤Wz¶¥¬q©Ê¤ÀªR«á¤´»Ý¦A¶i¦æPhase3 (¹wp2021¦~¶}©l)¡A¤é²±»{¬°GSK744°Ý¥@¦Ü¤Öܬ«Ý2023¦~¥H«á¡C µù¤@¡BGKS744ªºÁ{§É³]p¸ê®Æ¦p¤U¡G http://www.clinicaltrials.gov/ct2/show/study/NCT02076178?term=gsk744&rank=2 http://www.clinicaltrials.gov/ct2/show/study/NCT02120352?term=gsk744&rank=1 (3) GSK744¥Dn½ÄÀ»Tenofovir+EmtricitabineªºHIV¹w¨¾©Ê¨Ö¥Î²Õ¦X¡A¦ý»P¶D¨D³Ì¥½½u¦h«§ÜÃĩʱwªÌªºTMB-355¨Ã¤£½Ä¬ð¡C (4) ¾Ú¥Ø«eªºªì¨B¬ã¨s¡AGSK744+Ribavirin¥i¹F¨ì»PÂû§À°sÀøªk¤§¨Ö¥Î¥D·FNRTI (Nucleoside Reverse Transcriptase Inhibitors¡A¤ÏÂà¿ý酶§í¨î¾¯)¬ÛªñªºÀø®Ä¡A¥¼¨Ó½T¹ê¦³¥i¯à¨ú¥N³¡¥÷ªºNRTI¡A¦ý¤´¤£½ÄÀ»³Ì¥½½uªº¦h«§ÜÃĩʥ«³õ¡C (5) GSK744l¦ù¦ÛII (´O¤J酶§í¨î¾¯)¾÷Âà¡A¸Ó¾÷Âà¬Û¸ûNRTI¡BNNRTI («D¤ÏÂà¿ý酶§í¨î¾¯)¡BPI (³J¥Õ酶§í¨î¾¯)¡Kµ¥¡A§ó®e©ö²£¥ÍHIV§ÜÃĩʡC (6) TMB-355¥Ö¤Uª`®g¾¯«¬¡A¤´¥i¦bÂû§À°sÀøªkªº®Ø¬[¤U·f°tNTRI¥H¥~ªºÃĪ«¨Ö¥Î¡A»PGSK744¥i¯à¨ú¥N³¡¤ÀNRTIªº±¡ªp¤]¨Ã¤£½Ä¬ð¡C
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