TALECRIS BEGINS TESTING OF DRUG FOR DISSOLVING BLOOD CLOTS

Talecris Biotherapeutics announced that the first patient has been enrolled in its Phase I/II clinical trial investigating the ability of plasmin to treat acute peripheral arterial occlusion.

In patients with acute peripheral arterial occlusion, arterial blood flow to extremities, usually the legs, becomes blocked by a blood clot. Plasmin is a locally acting fibrin-binding thrombolytic derived from human plasma that can be infused directly into a clot via a catheter using minimally invasive techniques. Plasmin will be tested in patients with recent onset or worsening of symptoms resulting from a blood clot in a leg artery or arterial bypass graft.

"While intra-arterial administration of a clot-busting drug would be preferred to bypass grafting surgery, experience to-date has been disappointing, either because the available drugs don't demonstrate better effectiveness, or because the patient runs a higher than acceptable risk of bleeding complications resulting from the clot-busting drug," Anthony Comerota, the trial's principal investigator, said. "Plasmin represents a major new opportunity in treating these patients."

The plasmin study is a multicenter, multinational study. Stage 1 will enroll approximately 40 patients, and then approximately 140 patients will be included in Stage 2. Study endpoints will include restoration of blood flow, avoidance of surgical procedures to restore flow and continuing assessment of restored flow up to 30 days following plasmin administration.