Zurich, Switzerland, 24 January, 2011 – Kuros Biosurgery AG announced today the one year follow-up results of a Phase IIb clinical trial assessing the potential of KUR-111 (Viz.I-0401) in the treatment of patients with tibial plateau fractures that require fixation and grafting. As reported previously, the study achieved its primary efficacy endpoint, which was the demonstration of statistical non-inferiority to autograft with respect to the proportion of patients who achieved radiological fracture union at 16 weeks after grafting. During the one year follow-up, there was continuing improvement with radiological fracture union in 96.2% of patients treated with low dose KUR-111, 100% of those treated with high dose KUR-111 and 98.2% of those treated with autograft.  No safety concerns were raised.

The repair of tibial plateau fractures often requires the replacement of bone lost by compaction with autologous bone taken from another site in the patient. Harvesting of autologous bone has implications for the patient in terms of risk of infection and additional morbidity, as well as requiring additional surgery.  KUR-111 is designed to promote bone healing that can be considered as good as autograft, which is the gold standard in many orthopedic procedures.  For treatment of tibial plateau fractures, important efficacy endpoints include time to fracture union and amount of loss of reduction (i.e. the amount of subsidence of the repaired tibial plateau).

KUR-111 is composed of a variant of parathyroid hormone (vPTH), fibrin sealant and hydroxyapatite/tri-calcium phosphate (HA/TCP) granules. The product is applied directly to the fracture site as a mouldable putty that is able to form to the shape of the bone defect.  KUR-111 utilizes Kuros’ “TG-hook” technology for covalently binding vPTH into the fibrin sealant.

This Phase IIb trial is a randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study. The study treated 183 patients at 30 centers across Europe and Australia.  At 52 weeks, fracture healing as assessed by the investigator was consistent with assessment of radiographic union made by an independent panel of radiologists, with healing in 96.6% of the high dose KUR-111 group and 96.4% of the autograft group. There was no additional clinically relevant loss of reduction in any of the treatment groups compared to the post-operative assessment.   Treatment with KUR-111 was well tolerated with few adverse events reported in the long term follow-up


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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