Enrolment has begun in a clinical trial in the United Kingdom to assess the effectiveness and safety of the Vascular Wrap paclitaxel-eluting mesh (developed by Angiotech Pharmaceuticals) and Lifespan graft technology platform in haemodialysis patients. This announcement comes after Angiotech received a ‘letter of no objection’ from the Medicine and Healthcare products Regulatory Agency.
Specifically, this ten-centre, randomised trial is seeking to determine that haemodialysis patients who receive the Vascular Wrap paclitaxel-eluting mesh/Lifespan graft combination product experience fewer graft failures than those patients that receive the Lifespan graft alone. As a combination product, the graft serves as an access port for haemodialysis and the intent of the drug-eluting mesh is to prevent the scar formation that often leads to graft failure. The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech’s paclitaxel technology in a novel biomaterial enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures. Currently, about 50% of grafts fail within one year and about 75% within two years as a result of scar formation.
The company expects to enrol the first patient in the UK-based clinical trial in the next eight weeks. The company also intends to conduct a similar trial in the US. Both trials are expected to be about 24 months in duration, with enrolment taking approximately one year. The goal of the studies is to provide Angiotech with sufficient data to submit to regulatory authorities for the approval to market the products in the US and Europe.
“We have been very encouraged by both the preliminary results from the European bypass trial and the results of our pre-clinical data, and believe that we may be able to offer a better treatment option for haemodialysis patients,” said Dr Rui Avelar, Chief Medical Officer of Angiotech Pharmaceuticals. “We hope to improve the quality of life for these patients, who through the course of their treatments often have to endure multiple surgeries to replace AV grafts that have failed due to blockage caused by scar formation.”
Dr William Hunter, President and CEO of Angiotech Pharmaceuticals, commented, “We believe that haemodialysis is just one indication where the Vascular Wrap paclitaxel-eluting mesh may produce better outcomes for patients, with peripheral bypass surgery being another.”