Kuros completes patient recruitment in Phase IIA trial of KURS-212 in patients with severe burning requiring meshed skin graft

07-Feb-2008

Kuros Biosurgery AG announced that it has completed patient recruitment in a Phase IIa clinical trial evaluating KUR-212 (Viz.I-020502), its novel PDGF-fibrin combination product, for the treatment of patients with severe burns requiring autologous meshed skin grafting.

The aim of the Phase IIa clinical trial is to assess the safety and preliminary efficacy on wound healing of Kuros' product candidate KUR-212 in severely burned patients requiring autologous meshed skin grafting. This 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. In this trial, patients act as their own control with an area of the patient's burn being treated with a conventional meshed skin grafting procedure using staples while another area is treated with a meshed skin grafting procedure using KUR-212 without staples. The clinical trial which is being carried out in Germany has now recruited its target of 10 patients with partial and full thickness burns requiring meshed skin grafting. Dr Marcus Lehnhart, at Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil GmbH in Bochum, was the trial's principal investigator. This clinical trial was initiated following the completion of a Phase I study in human volunteers that showed that KUR-212 was well tolerated in normal acute wounds.

The aim of KUR 212 is to enable fixation of the graft to the wound without staples and, via the growth factor, to improve the overall healing of damaged tissue. It is expected that this activity will result in improved engraftment, earlier wound closure and reduced scarring.

KUR-212 is one of a family of Kuros combination products and consists of a variant of platelet-derived growth factor (PDGF), incorporated into a 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.

KUR-212 is licensed to Baxter under a collaboration and license agreement which was signed in 2005.

https://www.bionity.com/en/news/77599/kuros-completes-patient-recruitment-in-phase-iia-trial-of-kurs-212-in-patients-with-severe-burning-requiring-meshed-skin-graft.html