ZURICH, February 28, 2011 /PRNewswire/ --
- European Study is First Clinical Assessment of Kuros' Proprietary Synthetic Technology
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 pilot clinical trial investigating the safety and efficacy of KUR-023, its novel dural sealant product candidate.
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 that will recruit 40 patients. The primary endpoint refers to the prevention of intraoperative leakage with secondary endpoints related to safety and further efficacy 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: "Our dural sealant candidate, KUR-023, is our most advanced product candidate that is based on our proprietary synthetic technology platform. Initiation of this clinical study is an important milestone for Kuros."
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.
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' 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' product candidates 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 product candidates being in trauma and wound care.
Since its creation, Kuros has received over $100 million in funding. The company is located in Zurich, Switzerland.
Press Enquiries Kuros Didier Cowling, CEO +41(0)44-200-56-62 Alistair Irvine, Director of Business Development +41(0)44-200-56-62 For International Media Enquires: Citigate Dewe Rogerson David Dible, Nina Enegren +44(0)207-638-9571 For Swiss Media Enquires: IRF Communications Martin Meier-Pfister +41(0)43-244-81-40 Jan Gregor +41(0)43-244-81-54