June 09, 2009 – Talecris Biotherapeutics Inc., said today it was granted orphan drug designation by the FDA for the development of Plasmin (human) to treat acute peripheral arterial occlusion (PAO).
Talecris is currently investigating Plasmin in a phase I/II clinical trial designed to assess its ability to treat PAO. Currently, there are no FDA approved treatments for acute PAO. Safety and dosing results from the first clinical trial of Plasmin in humans, a phase I/II study in hemodialysis graft occlusion, have recently been published (Shlansky-Goldberg et al., J Thromb Haemost 2008; 6: 944-950).
Plasmin is now being tested in a phase I/II multicenter clinical trial to investigate dose escalation and safety of Plasmin in acute PAO. Additional study outcomes for assessment include Plasmin’s ability to restore blood flow and avoidance of a surgical procedure to restore blood flow.
For more information: www.talecris.com