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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

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 (Alpha 1-Proteinase Inhibitor [Human]) increased levels of the alpha 1 protein in patients with alpha 1antitrypsin (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.

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 CT lung densitometry to measure the degree of lung tissue preservation over time. The SPARTA study will be a multicenter trial and is scheduled to begin in the second half of 2013.

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