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| June 2, 2010 Kuros completes patient recruitment in Phase IIb study of KUR-113 in patients with tibial shaft fractures Study assessing the safety and efficacy of KUR-113 expected to report in H1 2011 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”. About tibial shaft fractures The tibia is the major bone between the knee and ankle, often referred to as the shin bone. Fractures of the tibial shaft are the most common long-bone fractures treated by an orthopedic surgeon. They are generally regarded as difficult to treat due to the risk of nonunion and other secondary complications. Improving the healing rate and reducing the incidence of secondary complications is therefore of great importance to these patients. About Kuros www.kuros.ch Kuros is a biotechnology company that is focused on the development of novel biomaterials and bioactive-biomaterial combinations for trauma, wound and spinal indications. Kuros’ combination products are designed to mimic the body’s natural healing process. The products consist of fusion proteins of naturally occurring bioactive factors, covalently incorporated into fibrin or synthetic matrices. The incorporation of the biologically active molecules into the injectable matrices aims to maximize their activity by retention at the site of action. Kuros products are designed to combine ease of application with localized delivery. Kuros has a number of methodologies to achieve the desired retention and release profiles of the biologically active molecules. Kuros’ has a diverse pipeline of product candidates with its most advanced products being in trauma and wound care. Since its creation in 2000, Kuros has raised over $100 million. The company is located in Zurich, Switzerland. Press Enquiries Kuros Didier Cowling, CEO +41 (0)44 200 56 62 Alistair Irvine, Director of Business Development +41 (0)44 200 56 62 For Swiss Media Enquires: The IRF Communications Martin Meier-Pfister +41 (0)43 244 81 40 Jan Gregor +41 (0)43 244 81 54 For International Media Enquires: Citigate Dewe Rogerson David Dible, Amber Bielecka, Nina Enegren +44 (0)207 638 9571 |
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