The aim of the Phase IIa clinical trial is to assess the safety and preliminary efficacy on wound healing of Kuros’ product candidate KUR-212 in severely burned patients requiring autologous meshed skin grafting. This procedure involves the use of the patient’s own skin, taken from an unaffected part of their body, which is meshed to increase its size, and then grafted onto the burn site. In this trial, patients act as their own control with an area of the patient’s burn being treated with a conventional meshed skin grafting procedure using staples while another area is treated with a meshed skin grafting procedure using KUR-212 without staples. The clinical trial which is being carried out in Germany has now recruited its target of 10 patients with partial and full thickness burns requiring meshed skin grafting. Dr Marcus Lehnhart, at Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH in Bochum, was the trial’s principal investigator. This clinical trial was initiated following the completion of a Phase I study in human volunteers that showed that KUR-212 was well tolerated in normal acute wounds.
The aim of KUR 212 is to enable fixation of the graft to the wound without staples and, via the growth factor, to improve the overall healing of damaged tissue. It is expected that this activity will result in improved engraftment, earlier wound closure and reduced scarring.
KUR-212 is one of a family of Kuros combination products and consists of a variant of platelet-derived growth factor (PDGF), incorporated into a fibrin sealant. The growth factor is gradually released during cell infiltration of the matrix, stimulating cell growth and thus promoting the skin repair process. This mechanism has been shown to lead to improved wound healing in a number of preclinical models.
KUR-212 is licensed to Baxter under a collaboration and license agreement which was signed in 2005.
Didier Cowling, CEO of Kuros, commented: “I am pleased that we have completed patient recruitment in this important Phase IIa trial of KUR-212. Kuros’ new therapeutic approach aims to improve the outcome of meshed skin grafting in severely burned patients and we intend to announce the preliminary results from this study in mid 2008.”
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 $55 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 Citigate Dewe Rogerson David Dible, Sylvie Berrebi +44 (0)207 638 9571
