Profibrix enters Phase III clinical trials

The trial (FINISH-3) is a multi-centre, randomised, single-blind, controlled Phase III trial in 672 surgical patients with mild to moderate surgical bleeding. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps versus gelatin sponge within each surgical indication, and to confirm the overall safety results from the Phase II Fibrocaps trial, which completed in 2011.

Paul Greenhalgh, Director of Design at Team and who managed the project, said “We are delighted for Profibrix to be initiating their Phase III trial. We’ve been working closely with the company for four years, developing from scratch the device that is capable of delivering their innovative product.” He added, “Profibrix have always treated us as an extension of their team. This, combined with gritty determination and a lot of hard work on both sides to deliver the device within the timelines, means the team here feels an enormous sense of pride over what we’ve achieved together. We are over the moon to see it reach such a significant milestone, especially when you consider that the development of the commercial device used in their Phase III trial was started just 10 months ago.”

For more information, visit: The Medicines Company.