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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

e III (RECOURSE)

L'essai clinique mondial de phase III (RECOURSE) est un essai à répartition aléatoire, mené en double insu pour comparer le TAS-102 à un placébo. Il est prévu que cet essai clinique mondial de phase III porte sur quelque 800 patients du Japon, d'Amérique du Nord, d'Europe et d'Australie. Le recrutement des patients a débuté en juin 2012. Les sujets sont des patients atteints de cancer colorectal récurrent à un stade avancé, non résécable, réfractaire aux chimiothérapies standard. Celles-ci comprennent les fluoropyrimidines, l'irinotécan, l'oxaliplatine, le bevacizumab et, chez les patients dont la tumeur abrite le gène KRAS de type sauvage, un anticorps monoclonal EGFR. Cet essai vise à comparer les patients qui sont répartis aléatoirement pour recevoir le TAS-102 ou un placébo afin d'étudier l'efficacité et l'innocuité du TAS-102. Le paramètre d'évaluation primaire est la survie globale. Les chercheurs principaux sont le Dr Atsushi Ohtsu , Directeur du Centre de développement clinique du National Cancer Center Hospital East (Japon), le Dr Robert J. Mayer du Dana Farber Cancer Institute (États-Unis) et le Dr Eric Van Cutsem de l'Hôpital universitaire de Gasthuisberg (Belgique).

À propos de Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical, filiale d'Otsuka Holdings Co., Ltd. (http://www.otsuka.com/en/) est une société pharmaceutique spécialisée dans la recherche et le développement et qui se concentre sur trois domaines : l'oncologie, les allergies et l'immunologie, ainsi que l'urologie. Sa philosophie d'entreprise prend la forme d'une promesse : « Nous œuvrons à l'amélioration de la santé h
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SOURCE Taiho Pharmaceutical Co., Ltd.
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