Talecris Biotherapeutics study shows that Prolastin-C (Alpha1-Proteinase Inhibitor [Human]) (A1PI) is as effective as Prolastin (Alpha1-Proteinase Inhibitor [Human]) in raising levels of alpha-1 protein in patients with alpha1-antitrypsin (AAT) deficiency. Results of the pharmacokinetic study are published in BMC Clinical Pharmacology, a peer-reviewed medical journal (http://www.biomedcentral.com/1472-6904/10/13).
Prolastin-C is a more purified and concentrated formulation of A1PI than Prolastin and is currently approved in the US and Canada for the treatment of panacinar emphysema in patients with AAT deficiency. AAT deficiency is a genetic condition in which low levels of the alpha-1 protein can result in emphysema. The active protein in Prolastin-C increases or "augments" alpha-1 protein levels in AAT deficient patients. Prolastin-C delivers twice the active protein per milliliter as Prolastin, cutting the infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min.
The pharmacokinetic (PK) study enrolled twenty-four subjects in a 24-week, multicenter, randomized, double-blind crossover trial that also included an open-label treatment phase with Prolastin-C only. The primary end point of the study was a measure of overall exposure to A1PI, known as area under the plasma concentration versus time curve (AUC), measured over seven days post infusion at steady state.
Study results demonstrate that Prolastin and Prolastin-C have comparable AUC measures with a 90 percent confidence interval of 0.97 to 1.09 (geometric LS mean ratio = 1.03). Four additional PK measures (Cmax, Tmax, T 1/2 and mean Ctrough) provide further support that the PK profiles of Prolastin and Prolastin-C are essentially superimposable.
This study also shows that the adverse events were similar for both treatments and occurred at a rate of 0.117 and 0.078 per infusion for Prolastin-C and Prolastin, respectively, with comparable severity of AEs.
During this PK study and a separate safety study with Prolastin-C, the most common drug related adverse reactions observed at a rate of >/= 1% in subjects receiving Prolastin-C were chills, malaise, headache, rash, hot flush, and pruritus. The most serious adverse reaction observed during these clinical studies with Prolastin-C was a rash on the abdomen and extremities in one subject.
"We're committed to advancing the care of the alpha-1 patient population and continue to invest in important clinical research in support of that goal," said Steve Petteway, Ph.D., Executive Vice President, Research and Development."The pharmacokinetic study shows Prolastin-C behaves the same way in the body as Prolastin, the leading alpha-1 augmentation therapy in North America for over 20 years."
Like Prolastin,Prolastin-C is indicated for the treatment of alpha1-antitrypsin (AAT) deficiency in patients with panacinar emphysema.