A Medical Device Daily

Angiotech Pharmaceuticals (Vancouver, British Columbia) said it would begin enrollment in a clinical trial in the UK to assess the effectiveness and safety of the Vascular Wrap paclitaxel-eluting mesh and Lifespan graft technology platform in hemodialysis patients.

The company received a “letter of no objection” from the Medicine and Healthcare products Regulatory Agency, an agency of the UK Department of Health.

The trial seeks to determine that hemodialysis patients who receive the Vascular Wrap paclitaxel-eluting mesh/Lifespan graft combination product experience fewer graft failures than patients that receive the Lifespan graft alone. As a combination product, the graft serves as an access port for hemodialysis and the intent of the drug-eluting mesh is to prevent the scar formation that often leads to graft failure.

Angiotech said it expects to enroll the first patient in the trial in the next eight weeks. The company also intends to conduct a similar trial in the U.S. Both studies are expected to be about 24 months in duration, with enrollment taking about 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 U.S. and Europe.

A substantial portion of the patients who undergo hemodialysis require vascular access, often achieved by surgically implanting a vascular graft to enable treatment. Angiotech said about 50% of grafts fail within one year and about 75% within two years as a result of scar formation.

“We have been very encouraged by both the preliminary results from the European bypass trial and the results of our preclinical data, and believe that we may be able to offer a better treatment option for hemodialysis patients,” said Dr. Rui Avelar, chief medical officer at Angiotech. “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, said, “we believe that hemodialysis is just one indication where the Vascular Wrap paclitaxel-eluting mesh may produce better outcomes for patients, with peripheral bypass surgery being another.”

The Vascular Wrap paclitaxel-eluting mesh/Lifespan graft combination product is designed to be used as a port for hemodialysis access or as a bypass for a blocked artery. The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech's paclitaxel technology in a novel biomaterial with the goal of mitigating scar formation caused by graft implantation and thereby potentially enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.

Biosecurity climbs on European agenda

The European biotech industry is starting to take bio-security issues increasingly seriously. EuropaBio , one of the industry's principal European associations, has just set up a task force aiming to counter the threat of deliberate theft or diversion of deadly pathogens and toxins for criminal purposes.

The task force also will have a role in biodefense – the broader range of measures to prevent and respond to possible biological attacks. It will oversee the assessment of medical countermeasures such as vaccines, antiviral and other drug treatments, and non-medical countermeasures in areas such as detection, protection, decontamination, and modeling and simulation.

The EuropaBio move comes in response to an invitation from the European Union to explore ways of coordinating industry and national initiatives. The task force is made up of companies and national associations with an interest in biotech applications related to biosecurity and biodefense. Its role is to increase general awareness, communicate industry's needs and interests to European and international authorities, and to promote R&D investment in biosecurity and biodefense. Distinct working groups will cover detection and diagnostics, vaccines, antibodies, genomics and proteomics, and decontamination and bioremediation.