Kuros announces further clinical progress in acute wounds
Kuros treats first patient in burns trial
Kuros Biosurgery AG announced that it has treated the first patient in a clinical trial to evaluate its novel PDGF-fibrin combination product for the treatment of severe burns.
The trial is a European study that is enrolling patients with partial and full thickness burns requiring grafting. The study is designed to assess the safety and preliminary efficacy of the Kuros' wound healing gel in burned patients and is due to report in the second half of next year. Initiation of this trial follows the successful completion of a Phase I trial in human volunteers that showed that Kuros' wound healing gel was well tolerated in normal acute wounds.
Severely burned patients frequently require skin grafting. A common grafting procedure involves the use of the patient's own skin, taken from an unaffected part of their body, which is meshed to increase its size and then grafted onto the burn site. The graft is commonly held in place with staples. Kuros' product is designed to both promote fixing of the graft to the wound site without staples and improve healing of the damaged tissue. It is expected that this activity will result in improved engraftment, earlier wound closure and will potentially reduce scarring. The product is also designed to reduce the discomfort associated with the use of staples.
The product consists of a variant of platelet-derived growth factor (PDGF), incorporated into Baxter Healthcare Corporations TISSEEL fibrin sealant. The growth factor is gradually released during cell infiltration of the matrix, stimulating cell growth and thus promoting the skin repair process. This mechanism has been shown to lead to improved wound healing in a number of preclinical models.
Kuros' product is licensed to Baxter subsidiaries under a major collaboration and license agreement which was signed in 2005. Under the terms of this agreement, treatment of the first patient in this study triggers a milestone payment from Baxter.
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