The aim of the trial is to assess the efficacy and safety of KUR-111 in comparison with autologous bone grafting. To ensure timely and accurate bone healing during the repair of tibial plateau fractures there is often the requirement to replace bone lost by compaction, with autologous bone, taken from another site in the patient. Harvesting of autologous bone has both pain and risk implications for the patient as well as requiring additional surgery. The use of KUR-111 is designed to replace the need for autologous bone.
KUR-111 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), fibrin sealant and hydroxyapatite/tri-calcium phosphate (HA/TCP) granules and is applied directly to the fracture site as a mouldable putty able to form to the shape of the bone defect. The study will evaluate if this material can provide physical support and promote bone healing via the local and sustained release of PTH as successfully as autograft.
A total of 183 patients have been randomized and treated in over 30 centers across Europe and Australia. The primary endpoint of this study is the rate of radiological fracture healing 16 weeks after surgery when compared to autograft. Kuros is expecting to report the outcome of this study in early 2010.
KUR-111 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-111.
Didier Cowling, CEO of Kuros, commented: “Completion of patient recruitment in Kuros’ first Phase IIb study is a significant achievement. Positive results from this study will enable Baxter to progress KUR-111 to the next stage of clinical development. If successful, this product will provide the surgeon with an effective alternative to current treatment options for such fractures.
About tibial plateau fractures
The tibial plateau refers to the upper end of the shin bone that articulates with the femur in the knee joint. Tibial plateau fractures are usually the result of high impact trauma, for example those caused by falls or road traffic accidents. They are challenging fractures for the orthopaedic surgeon, as the fracture needs very careful placement of the fragments to re-establish the articular surface of the knee joint in order to prevent the development of osteoarthritis of the knee or leg axis deviations.
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.
