NEWS
July 7, 2009
Kuros starts Phase IIb clinical trial with DUR-211 for diabetic foot ulcers
 
Kuros treats first patient in wound care Phase IIb study

Zurich, Switzerland, 7 July, 2009 - 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 today that it has treated the first patient in a Phase IIb clinical trial investigating KUR-211 (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 innovative 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 KUR-211 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 dosefinding 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.

Didier Cowling, CEO of Kuros, commented: “We are very pleased to progress KUR-211 into this large Phase IIb study. Diabetic ulcers are a significant medical problem with no currently marketed product that fully meets the medical need. We hope that KUR-211 will be a significant step forward in the treatment of these chronic ulcers, and we look forward to announcing the outcome of this study.”

About Diabetic Ulcers
There are approximately 50 million diabetics in the US and Europe, and due to life style issues and the aging population this number is increasing. The high prevalence of diabetes results in one out of every ten healthcare dollars in the US being spent on treating or managing diabetes or related complications, such as diabetic ulcers.

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. The prevalence of diabetic ulcers has been estimated to be as high as 2.4 million in the US and Europe in 2006.

About Kuros
www.kuros.com.

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 $100 million in funding. The company is located in Zurich, Switzerland.

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