RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--June 28, 2006--Talecris Biotherapeutics has initiated clinical trials with an alpha-1 antitrypsin (AAT) augmentation therapy produced by a manufacturing process that incorporates major technology changes into the current Prolastin® (Alpha-1-Proteinase Inhibitor (Human)) process. The clinical trials follow successful filing of an Investigational New Drug Application (IND) with the United States Food and Drug Administration (FDA) and will compare the AAT produced by the modified process to currently available Prolastin®. Because the manufacturing process for the AAT being studied utilizes major technology changes, Talecris will perform clinical trials to confirm that the pharmacokinetic and safety profiles are comparable to those for Prolastin® in people with alpha-1 antitrypsin deficiency (Alpha-1), a form of genetic emphysema.
