Angiotech Pharmaceuticals' corporate partner, Boston Scientific (BSC) has completed enrollment of its Taxus VI clinical trial. Taxus VI is an international trial studying 448 patients with complex coronary artery disease at 44 sites. It is designed to establish the safety and efficacy of the moderate-release formulation in the treatment of longer lesions (greater than or equal to 18 mm in length). The Taxus VI trial is using the BSC's internally developed Express stent. The trial - which includes the use of multiple stents - has a primary endpoint based on nine-month target vessel revascularization.
"This confirms Boston Scientific's commitment to treating real-world complex coronary lesions, which will ultimately benefit a greater breadth of patients," said William L. Hunter, president and chief executive officer at Angiotech. "The Taxus program is establishing itself as the most comprehensive database in drug-eluting stents and continues to consistently produce excellent safety and stellar efficacy, validating the proprietary polymer-based, paclitaxel-eluting stent technology."
The Taxus program is a series of clinical studies designed to collect data on Boston Scientific's proprietary polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. Polymer-based delivery of paclitaxel, at cytostatic doses, has demonstrated promising results in preclinical and clinical studies for reducing the processes leading to restenosis. The Company initiated the Taxus program in 1997.
Paclitaxel is a multifunctional drug with properties well suited for stent-based local drug delivery. The polymer allows for controlled delivery of the paclitaxel.
The Taxus I trial confirmed safety and reported zero thrombosis and zero restenosis. The Taxus II trial studied the treatment of de novo coronary lesions and demonstrated both safety and efficacy using the slow- and moderate- release formulations and confirmed safety with no thrombosis. Significant improvements were seen for clinical, angiographic and intravascular measures of stent performance compared with the bare control stent. The Taxus III trial, which studied the treatment of in-stent restenosis, also confirmed safety with no thrombosis. The Taxus IV trial has completed enrollment and nine-month follow-up is underway. This study is designed to assess the safety and efficacy of a slow-release formulation to support regulatory filings for U.S. product commercialization. The Taxus V trial has received conditional approval from the U. S. Food and Drug Administration to enroll patients and will study a higher risk patient population than Taxus IV, including patients with smaller vessels and longer lesions.
Boston Scientific has also initiated a transitional registry program (WISDOM) in a number of countries as part of a limited commercial launch of its Taxus paclitaxel-eluting stent system.
BSC has acquired worldwide co-exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and other vascular and non- vascular products.