Zurich, Switzerland, 10 June 2008 - Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combinations for trauma, wound and spinal indications, announced today that it has recruited the first patient into a Phase IIb clinical trial with KUR¬113 (Viz.I-040202), investigating the treatment of acute, open tibial shaft fractures. These fractures are associated with a high incidence of complications and may take many months to heal.
This investigational combination product, KUR-113, consists of a modified variant of parathyroid hormone (PTH) incorporated into a fibrin sealant. When mixed together, the bioactive and the sealant generate a fibrin composite that forms to the shape of the bone defect. KUR-113 is applied to the site of the fracture following surgical fixation with intramedullary nailing or plating.
KUR¬113 not only provides a matrix, into which bone healing cells can migrate, but also enables the delivery of PTH locally into the bone. The investigational product is designed to gradually release PTH from the matrix resulting in the stimulation of bone-forming cells, promotion of bone formation and acceleration of fracture repair.
This Phase IIb clinical trial is a multi-center, randomised, controlled, open label (dose-blinded) dose-finding study that will evaluate the efficacy and safety of KUR-113 as an adjunct to current standard of care in the treatment of patients with acute open tibial shaft fractures. Patients will be recruited from approximately 30 centers across Europe. The study will compare the proportion of patients healed six months after treatment with various doses of KUR-113 as an adjunct to surgical management versus surgical management alone.
KUR-113 is licensed to Baxter under a collaboration and license agreement that was signed in 2005. Under the terms of this agreement, recruitment of the first patient into this study triggers a milestone payment to Kuros.
KUR-111, Kuros’ other long bone regeneration product, is currently in a Phase IIb clinical study in tibial plateau fractures.
Didier Cowling, CEO of Kuros, commented: “We are pleased with the continuing progress we are making with our bone regeneration programmes. KUR-113 is designed to stimulate in-situ bone formation with the aim of increasing the speed of successful repair and reducing the rate of secondary interventions. We believe KUR-113 has the potential to be used as an adjunct treatment in many long bone fractures.”
About open tibial fractures
An open fracture is a broken bone that penetrates the skin and often requires immediate surgery to clean the area of the injury. Open fractures are typically caused by high-energy injuries such as car crashes, falls, or sports injuries. Open fractures usually take longer to heal because of the extent of injury to the bone and the surrounding soft-tissues.
The standard of care for open long bone fractures, such as tibial shaft fractures, comprises soft tissue management, fracture reduction, and internal fixation using plating or intra-medullary nailing. Around 150,000 tibia/fibula open reductions with internal fixation are performed in the US every year.
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, Kuros has received over $80 million in funding. The company is located in Zurich, Switzerland.
Press Enquiries
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Didier Cowling, CEO +41 (0)44 200 56 62
Alistair Irvine, Director of Business Development +41 (0)44 200 56 62
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