Talecris initiates clinical trial to evaluate 2 doses of PROLASTIN-C for emphysema due to AAT deficiency

Dec 10 2010

Talecris Biotherapeutics, Inc. (Nasdaq: TLCR) announced today the initiation of a clinical trial evaluating the safety and the pharmacokinetic profile of two doses of PROLASTIN®-C (Alpha(1)-Proteinase Inhibitor [Human]) (A1PI), a therapy indicated for chronic augmentation and maintenance in adults with emphysema due to alpha(1)-antitrypsin (AAT) deficiency. AAT deficiency is a rare, genetic disorder in which low levels of the alpha(1) protein circulating in the lungs can increase an individual's risk of developing emphysema.

This study will investigate the safety and pharmacokinetic profile of a higher dose, 120 mg/kg weekly, of PROLASTIN-C versus the licensed dose of 60 mg/kg weekly.  Subjects in the study will be randomized to receive either the 120 mg/kg dose or the 60 mg/kg dose for 8 weeks.  Subjects will then cross over to the alternate dose for an additional 8 weeks.  The study will be conducted at five sites across the United States.  Further information regarding this ongoing study can be found on ClinicalTrials.gov (study identifier NCT01213043).

"As part of our ongoing commitment to the Alpha-1 community, Talecris is exploring the possible use of higher doses of PROLASTIN-C in patients with emphysema due to AAT deficiency," said Kim Hanna, Vice President of Clinical Development at Talecris. "Data from this study may set the foundation for future research to further evaluate higher doses."

SOURCE Talecris Biotherapeutics, Inc.