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Kuros Completes Recruitment in Clinical Study with its Novel Dural Sealant Product Candidate

Published on 2011-08-19. Author : SpecialChem

Zurich, Switzerland -- Kuros Biosurgery AG, a biotechnology company focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, wound and spinal indications, has completed patient recruitment in a clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate. Kuros intends that this trial will support CE Marking of KUR-023.

KUR-023 is a synthetic hydrogel-based sealant that utilises Kuros' synthetic technology. The product candidate is administered as a spray with the aim of ensuring water-tight closure of incisions or tears through the dura mater. It is intended to be used as an adjunct to normal closure techniques such as suturing.

The trial is a European, single arm, multi-center study in which 41 patients have been treated. The primary endpoint refers to the prevention of intraoperative leakage with secondary endpoints related to safety and further effectiveness assessment.

KUR-023 is delivered from a double barrelled syringe with a mixing spray tip. The product candidate is delivered as a spray which then arrives on the dura as a liquid, conforms to the surface, and quickly polymerises. The applied gel is expected to adhere strongly to the dural surface and be able to withstand cerebral pressures in excess of those experienced in a patient. The gel is designed to be easy to apply, to swell minimally (addresses a common problem with hydrogels), to dissolve over a period of a few months and not to interfere with the natural healing process.

Kuros' synthetic technology is based on technology originally developed by Prof. Jeffrey Hubbell. The technology uses a cross-linking chemistry which is highly specific, does not generate any heat and is an addition reaction, meaning that no chemicals are released during the polymerisation process.

Didier Cowling, Chief Executive Officer of Kuros, commented: "Kuros is pleased to have completed recruitment of this study and is especially pleased to have achieved this ahead of schedule. KUR-023 is the first product based on our synthetic technology to have entered into clinical studies and we look forward to reporting the results of this study in the near future."

About Dural Sealants

The brain and spinal cord are surrounded by a membrane called the dura mater. This membrane forms part of the blood-brain barrier and acts to contain the cerebrospinal fluid within the brain and spinal cord. During most cranial and some spinal surgeries the integrity of the dura mater is breached either intentionally by incision or unintentionally. Water-tight closure of any incision or tear in the dura mater is of clinical importance, since CSF leakage can result in complications such as delayed wound healing, compression of neurological tissues and infection (potentially causing meningitis). Dural Sealants are applied as an adjunct to the normal dural closure procedure, which is most commonly sutures.

About Kuros

Kuros is a biotechnology company that is focused on the development of novel biomaterials and bioactive-biomaterial combination products for trauma, spine and wound indications. Kuros has two biomaterial technology platforms, one based on fibrin sealants and the other based on a synthetic technology that can mimic fibrin in many of its attributes. These materials can be used alone or in combination with biologically active molecules. The synthetic technology is tailorable and allows generation of products that are delivered as liquids or gels but polymerise, in or on living tissues, to form materials with different physical properties. For example, Kuros' synthetic technology can be utilized to develop products ranging from an elastic and degradeable dural sealant to a strong and non-degradeable bone cement.

Kuros' has a diverse pipeline of product candidates with its most advanced product candidates being in trauma and wound care. Since its creation, Kuros has received over $150 million in funding. The company is located in Zurich, Switzerland.

Source: Kuros


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