Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, announced that it has completed recruitment in a phase II b clinical trial designed to investigate KUR-211 (Viz.I-020201) in the treatment of diabetic foot ulcers.
This Phase IIb clinical trial is a randomised, multi-center, controlled, parallel group dose-finding study to evaluate the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcers. KUR-211 is a bioactive therapy intended for topical treatment of diabetic foot ulcers, stimulating the granulation tissue formation, that aids wound closure. The study evaluates the effects of KUR-211 applied twice a week for maximum 16 weeks in addition to standard of care versus standard of care (SOC) alone.
KUR-211 consists of a modified variant of platelet-derived growth factor (PDGF) incorporated into a fibrin sealant and is applied to the wound as a foam. The innovative Kuros "TG-hook" technology enables the PDGF to be retained at the site for local exposure to migrating cells and for sustained delivery of PDGF on enzymatic cleavage of the matrix. It is believed that this novel approach may improve the frequency and speed of healing.
A total of 211 patients have been randomized and treated in over 27 centers across Europe including Russia. The primary endpoint of this study is percentage reduction in ulcer surface area after 4 weeks of treatment when compared to SOC alone. Patients are followed for 7 months following initial treatment. Kuros is expecting to report the outcome of this study around the middle of 2012.
Dr Virginia Jamieson, chief medical officer of Kuros, commented: “We are very pleased to have completed recruitment for this study with KUR-211 and we look forward to reporting the results of this novel approach to the treatment of diabetic foot ulcers.”
Kuros partnered with Baxter International Inc. for the development of KUR-211 under a collaboration and license agreement that was signed in 2005. Following the successful completion of this study, Kuros and Baxter will look for a partner that takes over responsibility for the further development of KUR-211.
There are approximately 285 million diabetics worldwide. Due to life style issues and the ageing population, this number is increasing. One in three Americans born in 2000 is projected to develop diabetes.
Diabetic foot ulcers are a complication of diabetes that is caused by a combination of a loss of sensitivity especially in the lower extremities and vascular damage. The patients often do not sense damage to the skin, which results in a small injury that develops into an ulcer. Due to impaired wound healing capabilities and an increased risk for infection diabetic foot ulcers often heal only very slowly or not at all, leading to major implications for the affected patients.
Diabetic foot ulcers are a major medical, social and economic problem worldwide with approximately 15 percent of diabetic patients developing an ulcer in their lifetime and approximately 15 percent of those patients developing an ulcer requiring an amputation.