Date: 2015-10-09
Type of information: Presentation of results at a congress
phase: 2b
Announcement: presentation of results at the 2015 Orthopaedic Trauma Association Annual Meeting in San Diego
Company: KUROS Biosurgery (Switzerland)
Product: KUR-211
Action
mechanism: protein. KUR-21 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: tibial plateau fractures that require fixation and grafting
Therapeutic area: Bone diseases
Country: Europe Russia
Trial
details: The Phase IIb trial was a randomized, controlled, open-label (dose-blinded), multi-center, dose-finding study in which 183 patients with fractures of the Tibial Plateau were treated with either iliac crest cancellous autograft, or high concentration or low concentration KUR-111.
Latest
news: * On October 9, 2015, Kuros Biosurgery announced that positive results of a Phase IIb trial assessing the potential of KUR-111 in the treatment of patients with tibial plateau fractures that require fixation and grafting will be presented at the 2015 Orthopaedic Trauma Association Annual Meeting in San Diego, California, by Dr. Tom Lyon, Director of Orthopaedics and Chief of Orthopaedic Trauma, NYU Lutheran Medical Center. The study achieved its primary efficacy endpoint, which was the demonstration of statistical non-inferiority to autograft with respect to the proportion of patients who achieved radiological fracture union at 16 weeks after grafting. At 16 weeks post-surgery, 84% of autograft treated patients and 84% of patients (Intent to treat populations) treated with the higher dose of KUR-111 had radiological fracture healing defined by an independent radiology panel using CT Scans.
Additional secondary endpoints included measuring radiographic healing, clinical healing and maintenance of reduction at the 16 week timepoint but also at earlier (6 and 12 weeks) and later (6, 12 and 24 months) timepoints. In the composite endpoint at 16 weeks, which combined CT and clinical outcomes, 72% of the patients treated with the high concentration of KUR-111 healed compared to 63% of those treated with autograft (Intent to treat populations). Maintenance of reduction was also demonstrated with minimal loss observed at all time points, out to the end of the study at 24 months. There were also no indications of any safety issues.
