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

misierte Doppelblind-Vergleichsstudie von TAS-102 und einem Placebo. Laut Planung werden insgesamt 800 Patienten aus Japan, Nordamerika, Europa und Australien an dieser globalen klinischen Phase-III-Studie teilnehmen. Die Patientenrekrutierung begann im Juni 2012. Die an der Studie teilnehmenden Patienten leiden an inoperablen, rezidivierenden kolorektalen Karzinomen im fortgeschrittenen Stadium und sind für herkömmliche Chemotherapie unempfänglich (Fluoropyrimidin, Irinotecan, Oxaliplatin, Bevacizumab sowie monoklonale EGFR-Antikörper im Falle von KRAS-Wildtyp-Tumoren). Im Zuge der Vergleichsstudie werden Patienten nach dem Zufallsprinzip TAS-102 oder ein Placebo erhalten, um so die Wirksamkeit und Sicherheit von TAS-102 näher zu untersuchen. Das Gesamtüberleben ist der primäre Endpunkt der Studie. Die wissenschaftlichen Leiter sind Dr. Atsushi Otsu , Leiter des klinischen Entwicklungszentrums am National Cancer Center Hospital East (Japan), Dr. Robert J. Mayer des Dana Farber Cancer Institute (USA) und Dr. Eric Van Cutsem vom Universitätskrankenhaus Gasthuisberg (Belgien).

Informationen zu Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical, eine Tochtergesellschaft der Otsuka Holdings Co., Ltd. (http://www.otsuka.com/en/), ist ein auf Forschung und Entwicklung ausgerichtetes, spezialisiertes Pharmaunternehmen, das sich in erster Linie auf die drei Gebiete Onkologie, Allergien und Immunologie sowie Urologie konzentriert. Die Unternehmensphilosophie spiegelt sich in folgendem Versprechen wider: „Wir streben nach einer Verbesserung der menschlichen Gesundheit und wollen zur Bereicherung der Gesellschaft beitragen." Insbesondere im Bereich Onkologie ist Taiho Pharmaceutical in Japan'/>"/>

SOURCE Taiho Pharmaceutical Co., Ltd.
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