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Integrated Analysis Demonstrates Alpha(1)-Augmentation Therapy Significantly Reduces Loss of Lung Tissue in Patients with AAT-deficiency-related Emphysema
Date:11/15/2010

RESEARCH TRIANGLE PARK, N.C., Nov. 15, 2010 /PRNewswire-FirstCall/ -- Talecris Biotherapeutics (Nasdaq: TLCR) announced today the publication of combined data from two studies demonstrating that augmentation therapy with Alpha(1)-Proteinase Inhibitor (Human) (A1PI) significantly reduces lung tissue loss in patients with emphysema related to Alpha(1)-antitrypsin (AAT) deficiency. Results of the studies, published as an integrated analysis of the raw data from two similar pilot trials, were published in the journal Respiratory Research. (http://respiratory-research.com/content/11/1/136)

AAT deficiency is a rare, genetic disease in which low levels of the AAT protein circulating in the lungs can increase an individual's risk of developing emphysema. Treatment with A1PI therapy augments or increases the levels of this protein in the lungs.

Two randomized, double-blind, placebo-controlled clinical trials investigated the effect of A1PI therapy on emphysema progression using change in lung density as a measure. Lung density is a validated and specific measure of tissue loss in emphysema that relates well to physiological and clinical features of the disease.

Although the two studies used different intravenous dosing regimens, they were comparable  in treatment duration, patient characteristics and the use of computed tomography (CT) to study lung density.  The similar characteristics of the studies allowed the pooling of the individual patient data, which increased the robustness of the analysis. An analysis of the data from both studies was conducted by Professor Robert A. Stockley, Birmingham, UK, and Professor Asger Dirksen, Hellerup, Denmark.  

The results of the integrated analysis demonstrated a mean change in lung density from baseline to the final CT scan of -4.082 g/L
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SOURCE Talecris Biotherapeutics
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