OrthoLogic to start phase III fracture repair trial:
This article was originally published in Clinica
Executive Summary
The US FDA has given OrthoLogic the go-ahead to begin a phase III clinical trial of its injectable synthetic peptide product, Chrysalin, for accelerating fracture repair. The trial is scheduled to begin enrolling around 500 patients from 25 to 30 medical centres this autumn. The enrolment process is expected to take approximately 24 months, with a six-month follow-up period. OrthoLogic, of Tempe, Arizona, has obtained the worldwide rights to use Chrysalin for all orthopaedic indications through a series of agreements with Galveston, Texas-based Chrysalis BioTechnology. Chrysalin's application for spinal fusion and articular cartilage defect repair is also being explored.