Date: 2015-10-15
Type of information: Presentation of results at a congress
phase: preclinical
Announcement: presentation of results at the 2015 North American Spine Society (NASS) event in Chicago
Company: Kuros Biosciences (Switzerland)
Product: KUR-211
Action
mechanism: protein. KUR-211 is intended for topical treatment of diabetic foot ulcers, stimulating the granulation tissue formation, that aids wound closure. It 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 retained at the site for local exposure to migrating cells and for sustained delivery of PDGF on enzymatic cleavage of the matrix. It is believed that this novel approach may improve the frequency and speed of healing.
Disease: lumber interbody spinal fusion
Therapeutic area: Bone diseases - Regenerative medicine
Country:
Trial details:
Latest
news: * On October 15, 2015, Kuros Biosurgery announce that positive pre-clinical data assessing the potential of KUR-115 as a lumber interbody spinal fusion treatment will be presented at the 2015 North American Spine Society (NASS) event in Chicago, Illinois, by Dr. Bryan W. Cunningham. Dr. Cunningham was lead investigator of the study which was carried out at the Orthopaedic Spinal Research Institute, University of Maryland. The objective of the study was to evaluate and compare the efficacy of KUR-115 in various concentrations versus autograft and bone morphogenetic protein-2 (BMP-2) controls for lumbar interbody spinal arthrodesis. The study achieved its primary objective which was the demonstration of a fusion identified at 4 and 10 months in 8/8 levels treated with the optimal concentration of KUR-115 (0.4 mg/mL) as well as the autograft and BMP-2 controls; all following a direct lateral surgical approach, complete diskectomy and endplate decortication at L2-L3 and L4-L5. Flexion-extension and lateral bending exhibited reduced segmental motion for all treatment groups at 4 months versus the non-operative intact spine (p<0.05). By 12 months, both axial rotation and flexion-extension motion were significantly lower than the intact spine (p<0.05). Histopathology indicated no evidence of foreign body/inflammatory reaction or significant pathological changes in any specimens. There were also no significant intra-or peri-operative complications in any cases. The pre-clinical study was performed on 32 skeletally mature sheep and randomized into post-operative time periods of 4 months (n=20) and 10 months (n=12). Treatment was administered using rectangular PEEK cages (sample size of n=8) prefilled with the following treatments per time period: 4 Month Treatments – KUR-115 at 0.2 mg/ml, 0.4 mg/ml and 0.7mg/ml in a fibrin matrix, autograft and bone morphogenetic protein-2 (BMP-2). 10 Month Treatments - KUR-115 at 0.4 mg/ml in fibrin, autograft and BMP-2.
