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Studie von Grifols zeigt, dass eine höhere Dosis von PROLASTIN-C den Alpha1-PI-Spiegel in Patienten mit AAT-Mangel in den normalen Bereich anhebt
Date:5/22/2013

PHILADELPHIA, 22. Mai 2013 /PRNewswire/ -- Grifols, ein globales Unternehmen der Gesundheitsbranche mit Sitz in Barcelona, Spanien, präsentierte die Ergebnisse einer Studie, die aufzeigt, dass eine höhere Dosis von PROLASTIN©-C (Alpha1-Proteinasehemmer [human]) den Spiegel des Alpha1-Proteins in Patienten mit Alpha1-Antitrypsinmangel (AAT) auf ein Niveau anhebt, das innerhalb des für gesunde Menschen normal bezeichneten Bereichs liegt. ATT-Mangel ist eine lebensbedrohliche, genetische Erkrankung, bei der der niedrige Spiegel des Alpha1-Proteinasehemmer-Proteins (A1PI) zu Emphysemen führen kann.

Die Ergebnisse der PROLASTIN-C SPARK-Studie, eine pharmakokinetische klinische Studie mit Mehrfachdosen, wurden am 21. Mai auf der Jahrestagung der American Thoracic Society (ATS) präsentiert. Die Daten der Studie zeigten, dass wöchentliche Infusionen von PROLASTIN-C bei 120 mg/kg die Serumkonzentration des A1PI-Proteins auf ein proportional höheres Niveau brachte als wöchentliche Infusionen von 60 mg/kg, die derzeit für PROLASTIN-C zugelassene Dosis. Des Weiteren erhöhte die Dosis von 120 mg/kg die Serumkonzentration von A1PI in den mikromolaren Bereich von 20 - 53, der bei gesunden Menschen als normal angesehen wird. Beide Dosen waren sicher und wurden von den Probanden mit AAT-Mangel gut toleriert.

„Diese Daten zeigen, dass die Dosis von 120 mg/kg PROLASTIN-C zu höheren physiologischen A1PI-Konzentrationen führt als die derzeit empfohlene Dosis von 60 mg/kg, und sie bestätigen das vorhersehbare PK-Profil der Augmentationstherapie", unterstreicht Dr. Mark Brantly , Professor für Medizin am University of Florida College of Medicine.

Grifols verwendet die Daten der SPARK-Studie als Basis für eine größ
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SOURCE Grifols
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