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Taiho Pharmaceutical présente une demande d'homologation pour la fabrication et la commercialisation du nouvel agent antitumoral TAS-102
Date:2/26/2013

) et dont le but ultime est l'enregistrement et l'immatriculation de cet agent.

Taiho Pharmaceutical croit que le TAS-102 apportera une contribution significative aux patients atteints de cancer et elle poursuivra ses efforts de développement afin d'en élargir son utilisation.

À propos de TAS-102

Le TAS-102 est un agent antitumoral, composé d'un mélange de Trifluorothymidine (FTD), un nucléoside qui s'intègre à l'ADN et inhibe de nombreuses fonctions génétiques requises pour la prolifération de cellules cancéreuses et de tipiracil hydrochloride (TPI), un inhibiteur de thymidine phosphorylase (qui dégrade la FTD) qui maintient une concentration sanguine effective de FTD. TAS-102 est administré par voie orale à raison de 70mg/m2/deux fois par jour durant cinq jours suivi de deux jours de repos, le tout répété deux fois. Après quoi les patients subissent une période de repos de 14 jours afin d'obtenir un cycle de 28 jours pour chaque essai.

À propos de l'essai clinique de phase II portant sur le TAS-102

L'essai de phase II a été effectué auprès de 172 patients dans 20 centres médicaux au Japon sur une période allant d'août 2009 à avril 2010. L'étude cible une condition pour laquelle il n'existe pas de thérapie pleinement établie - spécifiquement, chez les patients réfractaires à la chimiothérapie standard pour le traitement du cancer métastatique colorectal, ayant reçu au moins deux régimes contenant un mélange de fluoropyrimidine, d'irinotécan et d'oxaliplatine. Les patients ont reçu de manière aléatoire soit du TAS-102 (114 cas) ou un placebo (58 cas). L'indicateur principal de résultats final était le taux de survie général des patients.

À propos de l'essai clinique mondial de phas
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SOURCE Taiho Pharmaceutical Co., Ltd.
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