Kuros completes patient recruitment in a Phase IIb trial of KUR-111 in patients with tibial plateau fractures

09-Jun-2009 - Switzerland

Kuros Biosurgery AG announced that it has completed patient recruitment in a Phase IIb clinical trial designed to assess the efficacy and safety of KUR-111 (Viz.I-0401) in tibial plateau fractures. 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.

https://www.bionity.com/en/news/101746/kuros-completes-patient-recruitment-in-a-phase-iib-trial-of-kur-111-in-patients-with-tibial-plateau-fractures.html