Kuros Biosurgery AG Announces Results Of ONE-Month Follow-Up Of Phase IIa Trial of KUR-212 in Patients with Burns requiring Mesh Grafting; KUR-212 Meets Phase IIa Trial Primary Endpoint
This Phase IIa clinical trial is designed to assess the safety and effects on wound closure (full re-epithelialization) of KUR-212 over two separately reported periods of 1 and 12 months respectively. The 12 month data will be reported in Q2 2009. A total of 10 patients from one centre participated in the study. Autologous mesh grafting is a procedure in which a patient’s skin is taken from an unaffected site on their body, meshed so that it can cover a larger area and applied to the burn site.
KUR212 aims to replace staples as the standard fixation method for skin grafts and, due to the presence of the growth factor, aims to improve the healing of the damaged tissue. In this study, patients served as their own control with an area of graft that was stapled and an area of graft that was treated with KUR-212.
No treatment-related adverse events, or safety issues were observed in any of the 10 patients during the one-month follow-up. Although the small sample size precluded statistical evaluation of efficacy and patient preference, a difference was observed in the time to wound closure between treatments for the 1:3 meshing ratio, with a shorter time for the KUR-212-treated sites, and it was also observed that patients expressed a preference for KUR-212 over staples.
KUR-212 is one of a family of Kuros combination products and consists of a variant of 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 Healthcare Corporation under a collaboration and license agreement, which was signed in 2005.
Dr. Marcus Lehnhart, at Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH in Bochum, was the trial’s principal investigator and commenting on the trial, he said: ”The one-month results from the Phase IIa study look promising, but a larger study is needed.“
Didier Cowling, Chief Executive Officer of Kuros, said: “Kuros is pleased to report that the trial met its primary endpoint (safety) following the use of KUR-212 in these burn patients. Given the promising one-month follow-up results seen in this study we look forward to advancing into a Phase IIb study. We hope this will further demonstrate the potential of KUR-212 as an important new treatment in skin graft procedures.”
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 $90 million in funding. The company is located in Zurich, Switzerland.