Kuros starts Phase IIb clinical trial with KUR-211 for diabetic foot ulcers
Kuros Biosurgery AG announced that it has treated the first patient in a Phase IIb clinical trial investigating KUR211 (Viz.I-020201) in the treatment of diabetic foot ulcers.
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 Kuros “TG-hook” technology enables the PDGF to be covalently bound into the fibrin matrix and maintained within the applied product allowing its sustained release from the matrix into the wound through enzymatic cleavage. As a result KUR211 not only provides a matrix into which skin cells can migrate, but it also facilitates the sustained delivery of PDGF. It is hoped that this novel approach may lead to improved wound healing.
This Phase IIb clinical trial is a randomised, multi-center, controlled, parallel group dose-finding study that will evaluate the efficacy and safety of KUR-211 used as an adjunct to standard of care in patients with diabetic foot ulcer. Approximately 210 patients will be recruited at around 30 centers across Europe including Russia. The study will evaluate the effects of KUR-211 in addition to standard of care versus standard of care alone.
Kuros partnered with Baxter International Inc. for the development of KUR-211 under a collaboration and license agreement that was signed in 2005.
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