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Pinnacle Biologics beantragt Zulassung neuer Indikationen in Deutschland und Frankreich
Date:12/5/2012

AMSTERDAM und BANNOCKBURN, Illinois, 5. Dezember 2012 /PRNewswire/ -- Pinnacle Biologics, BV. hat heute bekanntgegeben, dass es Zulassungsanträge neuer Indikationen bei den deutschen und französischen Gesundheitsbehörden, dem Bundesinstitut für Arzneimittel und Medizinprodukte bzw. der Nationalen Behörde für die Sicherheit von Arzneimitteln und Medizinprodukten (Agence nationale de sécurité de médicaments et des produits de santé) eingereicht hat. Diese beziehen sich auf die Photodynamische Therapie (PDT) mit PHOTOFRIN® (Porfimer-Natrium) für die therapeutische Indikation inoperabler, fortgeschrittener hilärer Cholangiokarzinome (CCA). Pinnacle ist ein Unternehmen für biopharmazeutische Technologie, das neuartige Therapien für die Onkologie und seltene Erkrankungen entwickelt und herstellt.

Die hiläre CCA (Klatskintumor) der oben genannten Indikation ist eine seltene Untergruppe der Krebserkrankungen, die am Konvergenzpunkt des rechten und linken Lebergangs auftritt[1].

„Die Zulassungsanträge spiegeln unser kontinuierliches Engagement wider, um die PDT-Therapie den Medizinern und Patienten weltweit zugänglich zu machen und - was noch wichtiger ist - weiterhin Therapien zu entwickeln, die seltene Erkrankungen wie das Cholangiokarzinom behandeln", sagte Guillermo Herrera, Vorstandsvorsitzender und CEO von Pinnacle.

Über Photodynamische Therapie (PDT) und PHOTOFRIN

Die Photodynamische Therapie mit PHOTOFRIN ist ein zweistufiger Prozess, der sowohl die Anwendung von Licht als auch die Verabreichung des Medikaments erfordert. In der ersten Stufe der PDT wird PHOTOFRIN intravenös verabreicht. In der zweiten Therapiestufe nach der Injektion mit PHOTOFRIN wird dann Belichtung mit nicht-Wärme-Laserlicht über 40 bis 50 Stunden verwendet. Bei Injektion wird PHOTOFRIN  von bestimmtem Gewebe angezogen, vor allem von
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SOURCE Pinnacle Biologics, Inc.
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