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Taiho Pharmaceutical ansöker om godkännande att tillverka och sälja det nya antitumörpreparatet TAS-102
Date:2/26/2013

harmaceutical anser att TAS-102 kommer att vara ett viktigt tillskott för cancerpatienter och kommer att fortsätta sitt utvecklingsarbete för att vidga dess användning.

Om TAS-102
TAS-102 är ett antitumörpreparat som består av en kombination av trifluorotymidin (FTD), en nukleosid som införlivas i DNA och stör olika genetiska funktioner som krävs för att cancerceller ska kunna föröka sig, samt tipiracil hydrochloride (TPI), en hämmare av tymidin-fosforylas (som bryter ner FTD) vilket upprätthåller en effektiv blodkoncentration av FTD. TAS-102 administreras två gånger om dagen för att uppnå en total dagsdos på 70mg/kvadratmeter i fem dagar, följt av två dagars vila. Detta repeteras sedan en andra gång. Sedan följer en 14 dagar lång viloperiod, vilket ger ett 28-dagars schema för en kur.

Om TAS-102 klinisk fas-II studie
172 patienter från 20 vårdinrättningar i Japan deltog i fas-II studien som genomfördes under perioden augusti 2009 till april 2010. Målgruppen för studien var ett område där det för närvarande inte finns någon allmänt etablerad behandlingsterapi i Japan – närmare bestämt patienter som är refraktära mot standard cytostatikabehandlingen för metastaserad kolorektal cancer och som redan har fått minst två behandlingsregimer innehållande fluoropyrimidin, irinotekan och oxaliplatin. Patienterna valdes slumpmässigt ut för att få TAS-102 (114 fall) eller placebo (58 fall). Det primära effektmåttet var total överlevnad.

Om den globala kliniska fas-III studien (RECOURSE)


Den globala kliniska fas-III studien (RECOURSE) är en randomiserad, dubbelblind jämförande studie av TAS-102 ge
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SOURCE Taiho Pharmaceutical Co., Ltd.
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