08:00 , Dec 3, 2012 |  BC Week In Review  |  Clinical News

Alpha-1 HC Aerosol recombinant alpha-1 proteinase inhibitor regulatory update

The European Commission granted Orphan Drug designation to Grifols' Alpha-1 HC Aerosol to treat cystic fibrosis (CF). The aerosolized formulation of alpha-1 proteinase inhibitor, an alpha 1-antitrypsin ( AAT ) inhibitor of elastase protease, is...
07:00 , Oct 15, 2012 |  BC Week In Review  |  Clinical News

Recombinant Alpha1-Proteinase Inhibitor: Phase II started

Grifols began a double-blind, placebo-controlled, dose-escalation, U.S. Phase II trial to evaluate 100 and 200 mg Alpha-1 HC aerosol daily via nebulizer for 3 weeks in 30 patients. The product has Orphan Drug designation in...