Kuros Completes Phase IIb Enrollment for Diabetic Foot Ulcers Treatment
The Phase IIb clinical trial is to evaluate the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcers.
Biotechnology company Kuros Biosurgery AG announced last week that it had completed recruitment in a Phase IIb clinical trial designed to investigate KUR211 (Viz.I-020201) in the treatment of 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.
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.
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.
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.
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.