May 22, 2013
/PRNewswire/ -- Grifols, a global healthcare company based in
, presented results from a study demonstrating that a higher dose of PROLASTIN
-Proteinase Inhibitor [Human]) increased levels of the alpha
protein in patients with alpha
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
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
. 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.
, 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.