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Taiho Pharmaceutical presenta una solicitud para fabricar y comercializar el nuevo agente antitumoral TAS-102
Date:2/26/2013

on cáncer y continuará sus esfuerzos de desarrollo para ampliar su uso.   

Acerca de TAS-102
TAS-102 es un agente antitumoral compuesto por una combinación de trifluorotimidina (FTD), un nucleósido que se incorpora al ADN e inhibe una variedad de funciones genéticas requeridas para la proliferación de células cancerígenas, y tipiracil hidrocloruro (TPI), un inhibidor de timidine fosforilasa (que degrada FTD) que mantiene una concentración de sangre efectiva de FTD. TAS-102 se administra dos veces al día para lograr una dosis diaria total de 70 mg/metro cuadrado durante cinco días seguido por dos días el resto y luego repetido una segunda vez. A esto le sigue un period de 14 días de descanso para hacer un programa de 28 días para un curso.  

Acerca del ensayo clínico de fase II de TAS-102
El ensayo clínico de fase II se realizó con la participación de 172 pacientes en 20 instituciones médicas en Japón, de agosto de 2009 a abril de 2010. El objetivo para el estudio es un área para la cual actualmente no hay una terapia totalmente establecida en Japón; específicamente, pacientes que rechazan la quimioterapia estándar para el cáncer colorrectal metastásico que han recibido al menos dos o más regímenes con fluoropirimidina, irinotecan y oxaliplatin. Se asignó aleatoriamente a los pacientes TAS-102 (114 casos) o placebo (58 casos). La principal valoración fue la supervivencia general.  

Acerca del ensayo clínico de fase III global (RECOURSE)
El ensayo clínico de fase III global (RECOURSE) es un estudio comparativo aleatorio, de doble ciego de TAS-102 frente a placebo. Es un ensayo clínico de fase III global que está previsto para reclutar un total de 800 pacientes de Japón, Norteamérica, Europa y Aus
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SOURCE Taiho Pharmaceutical Co., Ltd.
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