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·PÁÂCliff´£¨Ñ§Y®É¸Ô²Ó¦a¸Ñ»¡.¦¹¥~,³Ì·s¤@´Á²Ä¤@°]¸g¶g¥Z¤j½g´T¤¶²ÐÁp¥ÍßÓ(6471),¨ä¤¤½Í¤Î¸Ó¤½¥qªº§Ü·R´þßÓUB-421¬O¥i¿ëÃѤλPCD4¨üÅé°Ï¬q¤@(Domain1)µ²¦Xªº¤H·½¤Æ³æ®è§ÜÅé,¦Ó¸Ó°Ï¬q¥¿¬OHIV¯f¬r¶i¤J²Ó­Mªºµ²¦XÂI,¦]¦¹,UB-421¬Oª½±µ»PHIV¯f¬rÄvª§µ²¦XÂI,²£¥ÍÄvª§§í¨î§@¥Î,¸gÅé¥~¹êÅç,UB-421ªºµ²¦X¤O¤ñHIV¯f¬r±j100­¿,¦Ó³oºØÄvª§§í¨î§@¥Î¤]¸û¤£©ö²£¥Í§ÜßÓ©Ê.¨ä§@¥Î·|¤ñ¤¤¸Î¿ëÃÑCD4¨üÅé°Ï¬q¤G(Domain2)ªºTMB-355­nÀu,¤£ª¾³oºØ»¡ªk¥¿½T§_?¦P®ÉUB-421¬O§_·|¼vÅT¨ì¥¼¨Ó¤¤¸Îªº«e´º?

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¡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¥L­ÌªºªþµÛ§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¥L­Ìªº¸ÕÅ示®e¡A§Q©óÃÄÃÒ®Ö­ã¡C¡v
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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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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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(8) TMB-355ªºÀR¯ßª`®g¾¯«¬¤w²Å¦X©t¨àÃÄ¸ê®æ¡A¥H¬ü°ê¼ç¦b¯f±w¤H¼Æ¡B­q»ù¦ô­p¡A¦~¾P°â¼ç¤O4»õ~5»õ¬ü¤¸¡C¤¤¸ÎªºTMB-355¹w­p¥i¤j´T´£¤ÉHIV¦h­«§ÜÃıwªÌªº¥Í¬¡«~½è»P¹Ø©R¡A¥Ñ©ó¥Ø«e«DªýÂ_¾÷Â઺ÃĪ«¬Ò·|²£¥Í§ÜÃĩʡA­YTMB-355¯u¯à¹F¨ì¨}¦n®ÄªG¡Aªø´Á¦Ó¨¥¡A¶D¨Dªº¯f±w±Ú¸s±N³vº¥²Ö¿n¡A4»õ~5»õ¬ü¤¸ªº¾P°â¼ç¤O¤´¦³¤W­×ªºªÅ¶¡¡C
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