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Clinical Hold on GSK761 NNRTI
 
 
  It was announced yesterday that the new promising ViiV/GSK NNRTI GSK761, formerly IDX899) was placed on clinical hold. ViiV said the reason for the FDA development hold on 'GSK-761', a drug developed by Idenix and licensed to ViiV and currently in Phase 2B trials, involved four reports of seizures as part of a clinical trial involving treatment-experienced patients.....the 4 patients with seizures were treatment experienced and were on the higher dose of gsk761 - 200 mg of gsk761 and patients were randomized only in this study to 200 or 100 of gsk761 or a control group where patients did not receive gsk761. all patients in the experienced trial were also receiving darunavir/rtv and raltegravir.
 
GSK New NNRTI Selects No Resistance Mutations in 7 Days of Monotherapy
GSK veteran chief virologist Marty St. Clair presented resistance data from two dose-ranging monotherapy studies of 761. Both were double-blind, ... www.natap.org/2010/ICAAC/ICAAC_30.htm
 
The FDA places GSK2248761 ('761', formerly IDX899) a NNRTI on ...
Feb 9, 2011 ... ViiV has said the reason for the FDA development hold on ... www.natap.org/2011/newsUpdates/021111_04.htm
 
 
 
 
 
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