Zurich, Switzerland, 2nd June 2010 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced today that it has completed recruitment in a 200 patient Phase IIb clinical trial designed to assess the efficacy and safety of KUR-113 (Viz.I-040202) in open tibial shaft fractures.
This study is a randomized, controlled, open-label (dose-blinded) dose finding study of the safety and efficacy of KUR-113 in the treatment of patients with acute open tibial shaft fractures. The aim of the trial is to assess the safety and efficacy of KUR-113 in combination with standard of care (SOC) vs SOC alone. The use of KUR-113 is designed to improve bone healing by reducing the time needed to achieve bone healing as well as the incidence of secondary interventions.
KUR-113 utilizes Kuros’ “TG-hook” technology for binding proprietary biologics into a fibrin sealant. The product candidate is composed of a variant of parathyroid hormone (vPTH) and fibrin sealant and is applied directly to the fracture site in the form of a paste. KUR-113 has been designed to deliver vPTH locally at the fracture site and to maintain this via the slow controlled release of vPTH over time from the fibrin matrix. The fibrin matrix also plays a further important role in the bone healing process by providing a physical scaffold for cell ingrowth. The trial will assess whether this approach is safe and efficacious.
A total of 200 patients have been randomized and treated in over 31 centers across Europe. The primary endpoint of this study is the proportion of patients healed at 6 months after surgery when compared to SOC alone. Kuros is expecting to report the outcome of this study in the first half of 2011.
Dr. Virginia Jamieson, Chief Medical Officer of Kuros, commented: “We are very pleased to have completed recruitment for this study with KUR-113 and we look forward to reporting the results of this novel approach to the treatment of open tibial shaft fractures in the first half of 2011.”
KUR-113 is licensed to Baxter International Inc. under a collaboration and license agreement which was signed in 2005. Following the successful completion of this study, Baxter will take over responsibility for the further development of KUR-113.
Didier Cowling, Chief Executive Officer of Kuros, commented: “Completion of patient recruitment in this large Phase IIb study is another significant step for Kuros. We look forward to broadening the application of this technology to additional orthopedic settings”