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Taiho Pharmaceutical stellt Zulassungsantrag zur Herstellung und Vermarktung des neuartigen Antitumormittels TAS-102
Date:2/26/2013

Beitrag für Krebspatienten leisten wird, und wird seine Entwicklungsbemühungen zur Erweiterung des Anwendungsgebiets daher weiter fortsetzen.

Informationen zu TAS-102
TAS-102 ist ein Antitumormittel, das neben Trifluorthymidin (FTD) auch Nukleosid enthält. Es wird in die DNA integriert und unterdrückt verschiedenste Genfunktionen, die zur Vermehrung von Krebszellen notwendig sind. Hinzu kommt außerdem Tipiracil-Hydrochlorid (TPI), ein Hemmstoff für Thymidinphosphorylase (baut FTD ab), der eine effektive FTD-Konzentration im Blut aufrechterhält. TAS-102 wird zweimal täglich verabreicht und unterliegt einer maximalen täglichen Dosierung von 70 mg/Quadratmeter über fünf Tage, gefolgt von zwei Tagen Pause vor Beginn des zweiten Behandlungszyklus. Im Anschluss folgt eine 14-tägige Ruhephase, sodass sich die Behandlung über einen Gesamtzeitraum von 28 Tagen erstreckt.

Informationen zur klinischen Phase-II-Studie von TAS-102
Die klinische Phase-II-Studie wurde in der Zeit von August 2009 bis April 2010 mit 172 Patienten an 20 medizinischen Einrichtungen in Japan durchgeführt. Die Studie zielt auf einen Bereich ab, für den es in Japan derzeit keine vollständig etablierte Therapie gibt – d. h. Patienten mit metastasierten kolorektalen Karzinomen, die für herkömmliche Chemotherapie unempfänglich sind und mindestens zweimal oder häufiger mit Fluoropyrimidin, Irinotecan und Oxaliplatin behandelt wurden. Nach dem Zufallsprinzip erhielten Patienten entweder TAS-102 (114 Fälle) oder ein Placebo (58 Fälle). Das Gesamtüberleben war der primäre Endpunkt der Studie.

Informationen zur globalen klinischen Phase-III-Studie (RECOURSE)
Bei der globalen klinischen Phase-III-Studie (RECOURSE) handelt es sich um eine rando
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SOURCE Taiho Pharmaceutical Co., Ltd.
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