Grifols Publishes Positive Phase I Safety Results for Plasmin, a Novel, Direct-Acting Thrombolytic, in the Journal of Thrombosis and Haemostasis
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.
About Peripheral Arterial Occlusion and Acute Limb Ischemia
Acute Limb Ischemia is a condition in which blood flow to the extremities, usually the legs, becomes blocked by a blood clot, also known as acute peripheral arterial occlusion (aPAO). Affecting approximately 150,000 people in North America and Europe each year, this condition is most common in people with underlying narrowing of arteries and gradual restriction of blood flow over time resulting from peripheral arterial disease. Without prompt intervention, acute limb ischemia can result in significant complications such as permanent nerve and muscle damage and, in the most severe cases, even amputation or death. There is an unmet medical need for a proven thrombolytic agent to treat aPAO. Current methods focus on pharmacologic, mechanical, or surgical removal of the blood clot, or bypass grafting to direct blood flow around the area of the clot. However, no drugs currently are approved for this indication in the U.S.
Plasmin is Grifols' novel, stabilized formulation of the naturally occurring blood protein plasmin. Grifols is currently investigating plasmin as a treatment for acute peripheral arterial occlusion, which are blood clots in the lower extremities. The phase 2 trial will assess plasmin's ability to dissolve clots by breaking their fibrin strands, thereby restoring blood flow in the affected artery.
Plasmin is in a class of therapies known as direct-acting thrombolytics because it exerts its effects directly on the blood clot. Indirect-acting thrombolytics, such as plasminogen activators currently used in clinical practice, first convert plasminogen into plasmin before targeting and dissolving the blood clot.
Grifols is a global healthcare company that produces plasma-derived therapies and manufactures hospital pharmacy products, intravenous solutions, diagnostic tools and medical devices. As the third largest global producer of plasma therapies, Grifols has a presence in more than 90 countries and is the world leader in plasma collection, with 147 plasma donation centers across the U.S. The centers collect protein-rich plasma for use in manufacturing the company's life-saving medicines to treat rare conditions such as bleeding disorders, immune deficiencies and genetic emphysema. The company's class A shares have been listed on the Spanish Stock Exchange (MCE:GRF) since 2006 and have been part of the Ibex-35 since 2008. In 2011, the company listed non-voting class B shares on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ via ADRs (NASDAQ: GRFS).