Talecris is attempting to succeed in acute PAO, the indication where NUVO had its spectacular failure. However, Talecris’ product is merely plasmin derived from human plasma, and it has all the drawbacks of a plasma-derived therapeutic.
>> Talecris Initiates Clinical Development Program Evaluating Plasmin for Dissolving Blood Clots and Restoring Blood Flow in Legs
Tuesday March 20, 9:10 am ET
First Patient Entered in Phase I/Phase II Trial RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Talecris Biotherapeutics, Inc. (http://www.talecris.com) announced today that the first patient has been enrolled in its Phase I/Phase II clinical trial investigating the ability of Plasmin to treat acute Peripheral Arterial Occlusion (aPAO). In patients with aPAO, 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 (within two weeks) onset or worsening of symptoms resulting from a blood clot in a leg artery or arterial bypass graft.
Anthony J. Comerota, M.D., Director, Jobst Vascular Center, Toledo, Ohio, and principal investigator for the study, commented on the importance of this clinical trial. "Significant unmet medical needs remain for patients who develop blood clots in their legs. 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. Plasmin works locally to dissolve the clot and has the potential to restore blood flow to the extremities with much less risk of bleeding. Plasmin represents a major new opportunity in treating these patients."
The Plasmin study is a multicenter, multi-national 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. For more information, please see www.clinicaltrials.gov.
Alberto Martinez, M.D., President and CEO of Talecris Biotherapeutics, highlighted the importance of this key milestone for Plasmin. "We continue to invest heavily in products and technologies that represent advances for the patients we serve. This trial and the overall Plasmin development program are excellent examples of our dedication to innovation."
About Acute Peripheral Arterial Occlusion (aPAO)
Acute Peripheral Arterial Occlusion (aPAO) is a condition in which blood flow to extremities, usually the legs, becomes blocked by a blood clot. Affecting approximately 100,000 people in the United States 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 (PAD). Without prompt intervention, aPAO 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 flow around the area of the clot. However, no clot-busting drugs currently are approved for this indication by regulatory authorities, and those currently used (plasminogen activators) may require a prolonged infusion averaging 24 to 36 hours and produce increased risk of bleeding complications.
About Talecris Biotherapeutics: Inspiration. Dedication. Innovation.
Talecris Biotherapeutics is a global biotechnology company that discovers, develops, and produces critical care treatments for people with life-threatening disorders in a variety of therapeutic areas including immunology, pulmonology, and hemostasis. Talecris is proudly building upon a 60-year legacy of innovation and a commitment to improving the lives of people who rely on its therapeutic products. With an emphasis on scientific inquiry and technological excellence, Talecris is expanding its current portfolio of products, programs, and services through its own world-class product development organization as well as through strategic initiatives that leverage its strengths with those of its partners. Talecris, which earned revenues exceeding $1 billion through the year ending June 30, 2006, is headquartered in biotech hub Research Triangle Park, N.C., and employs more than 3,000 talented people worldwide. To learn more about Talecris and how our employees are making a difference in the lives of patients and the healthcare community, visit www.talecris.com. <<
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