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RESEARCH TRIANGLE PARK, N.C.,
June 11, 2012 /PRNewswire/ -- Grifols, a global healthcare company based in
Barcelona, Spain, today announced publication of phase 1 study results demonstrating good safety and tolerability for the investigational therapy plasmin in treating patients with blood clots in the lower extremities, known as acute peripheral arterial occlusion (aPAO). These clots can block blood flow and thus result in nerve damage, limb amputation or potentially loss of life if not treated promptly.
Results of the multi-center study are published in the June issue of the
Journal of Thrombosis and Haemostasis.
In the study, 83 subjects received Grifols' plasmin, a stabilized protein derived from human plasma, to treat patients with recent-onset, arterial occlusions in native arteries or bypass grafts. The subjects were enrolled in seven sequential dose cohorts that received between 25- 175 mg of plasmin delivered locally via catheter. Seventy-eight subjects completed the study. Subjects were monitored for 30 days for clinical outcomes and laboratory parameters of safety.
Overall, there were no unexpected safety concerns with plasmin treatment. Nineteen patients (23%) had one or more serious adverse events (SAE); major bleeding occurred in four patients (4.8%); and minor bleeding in thirteen patients (15.7%); with no trend toward more SAEs or bleeding episodes at higher doses of plasmin. The data are consistent with prior studies of catheter-delivered thrombolytic drugs for lower extremity arterial or graft occlusion. While the study was not powered for efficacy, the data demonstrated that thrombolysis (>/= 50%) occurred in 79% of subjects receiving 125-175 mg of plasmin compared with 50% who received 25-100 mg.
"The desired clinical outcome is to quickly dissolve the clot while reducing the incidence and severity of bleeding complications that can occur with indirect thrombolytics," said Dr.
David Fineberg, Plasmin Medical Director at Grifols. "Our phase 1 results represent an important milestone in the development of plasmin as we continue into phase 2 efficacy trials."
A multi-national phase 2 efficacy trial of Plasmin is currently underway.