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Grifols SA’s Study Demonstrates Higher Dose Of PROLASTIN-C Increases Levels Of Alpha1-PI To Within Normal Range In Patients With AAT Deficiency-DJ


Wednesday, 22 May 2013 08:49am EDT 

Dow Jones reported that Grifols SA presented results from a study demonstrating that a higher dose of PROLASTIN(c) -C (Alpha(1)-Proteinase Inhibitor [Human]) increased levels of the alpha(1) protein in patients with alpha(1) antitrypsin ( AAT) deficiency to levels that are considered within the normal range for healthy individuals. AAT deficiency is a life-threatening, genetic condition in which low levels of the alpha(1) proteinase inhibitor (A1PI) protein can lead to emphysema. The results of the PROLASTIN-C SPARK study, a multidose pharmacokinetic clinical trial, were presented at the annual meeting of the American Thoracic Society (ATS) on May 21, 2013. Data from the study showed that weekly infusions of PROLASTIN-C at 120 mg/kg increased serum concentrations of the A1PI protein to proportionately higher levels than weekly infusions of 60 mg/kg, the currently approved dose of PROLASTIN-C. Furthermore, the 120 mg/kg dose raised serum concentrations of A1PI to the range of 20-53 micromolar, considered to be normal for healthy individuals. Both doses were safe and well tolerated in subjects with AAT deficiency. 

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