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Grifols study demonstrates higher dose of PROLASTIN-C increases levels of alpha1-PI to within normal range in patients with AAT deficiency
Date:5/22/2013

PHILADELPHIA, May 22, 2013 /PRNewswire/ -- Grifols, a global healthcare company based in Barcelona, Spain, presented results from a study demonstrating that a higher dose of PROLASTIN©-C (Alpha1-Proteinase Inhibitor [Human]) increased levels of the alpha1 protein in patients with alpha1antitrypsin (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 alpha1 proteinase inhibitor (A1PI) protein can lead to emphysema.

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. 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.

"These data demonstrate that a 120 mg/kg dose of PROLASTIN-C provides closer to physiologic A1PI concentrations than the currently recommended 60 mg/kg dose and confirm the predictable PK profile of augmentation therapy," concluded Dr. Mark Brantly , Professor of Medicine, University of Florida College of Medicine.

Grifols is using data from the SPARK study as the basis to proceed with a larger, long-term study of the two doses of PROLASTIN-C. The trial, known as SPARTA, will be the first and only clinical trial to evaluate the efficacy of PROLASTIN-C at the standard 60/mg/kg dose and the 120 mg/kg dose vs. placebo. The SPARTA study will use
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