VANCOUVER, Sept. 17 /PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc. , a global specialty pharmaceutical and medical device company, today announced positive preclinical data related to its Vascular Wrap(TM) paclitaxel-eluting mesh and Lifespan(R) graft technology platform at The Western Vascular Society 2006 Annual Meeting in La Jolla, California.
"We are excited by the potential of the Vascular Wrap paclitaxel-eluting mesh product in a variety of indications, including AV access for hemodialysis patients," said Dr. William Hunter, President and CEO of Angiotech Pharmaceuticals.
Although synthetic grafts are currently used in approximately 40 percent of hemodialysis patients who require a permanent vascular access, primary patency rates remain poor. Most graft failures are caused by growth of scar tissue inside the graft (neointimal hyperplasia) at the location where the graft is connected to the vein (the graft-vein anastomosis), and there are no proven treatments that effectively prevent it.
The purpose of this preclinical study was to evaluate the effect of the Vascular Wrap(TM) bioabsorbable mesh containing paclitaxel on inhibiting neointimal hyperplasia in an animal model of dialysis access failure. In this study, neointimal hyperplasia was reduced by a minimum of 87.6% in animals who received a paclitaxel-eluting mesh compared with animals who received no mesh.
"We are encouraged by 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 of Angiotech Pharmaceuticals. "These results, complemented by the extensive experience with paclitaxel in cardiovascular applications, have given us further confidence as we look to start our clinical studies in hemodialysis access."
Earlier in August, Angiotech announced the intent to launch a clinical trial in the United Kingdom to determine if hemodialysis patients who receive the Vascular Wrap paclitaxel-eluting mesh/Lifespan graft combination product experience fewer graft failures than those patients that receive the graft alone. Angiotech expects to enrol the first patient in the UK-based clinical trial this fall. The company also intends to conduct a similar trial in the U.S. 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 United States and Europe.
About the Study and Presentation
Dr. Ted Kohler, MD, MSc, of the Veteran Affairs Puget Sound Health Care System, is the principal investigator of this study, and presented the results today at the Western Vascular Society 2006 Annual Meeting held at the Hilton La Jolla Torrey Pines Hotel in La Jolla, California.
Commercially available grafts were surgically placed between the left common carotid artery and right external jugular vein in 40 animals, which were randomized to receive either no mesh or a 3 cm by 6 cm mesh placed around the graft-vein anastomosis containing one of four doses of paclitaxel (0.0, 0.3, 0.7 or 1.2 (micro)g/mm2). Animals in both control groups developed significant neointimal hyperplasia at the cross-section taken perpendicular to the graft at its most distal end: 10.5 +/- 6.8 mm2 and 6.4 +/- 3.2 mm2 in the no mesh and zero-dose mesh groups, respectively (P = .28). Compared with the zero-dose mesh group, neointimal area was significantly reduced in all paclitaxel mesh groups: 0.9 +/- 1.4 mm2, 1.3 +/- 1.5 mm2 and 1.2 +/- 1.4 mm2 in the three dose groups, respectively (P <= .008). There was no significant effect of the paclitaxel mesh on healing of the anastomosis or on the thickness of the adjacent vein.
More About Hemodialysis
Patients with severe kidney disease require hemodialysis to survive. Today there are an estimated 450,000 people in the U.S. with end-stage renal disease. Of these patients, approximately 325,000 undergo hemodialysis treatment and a substantial portion of these patients require vascular access (AV), which is often achieved by surgically implanting a vascular graft to enable treatment. Currently, about 50 percent of grafts fail within one year and about 75 percent within two years as a result of scar formation. These failures can result in the need for additional surgical procedures for hemodialysis patients who are already suffering exhaustive treatments.
About Angiotech Pharmaceuticals
Angiotech Pharmaceuticals, Inc. is a global specialty pharmaceutical and medical device company with 14 facilities in 6 countries and over 1,500 dedicated employees. Angiotech discovers, develops and markets innovative treatment solutions for diseases or complications associated with medical device implants, surgical interventions and acute injury. To find out more about Angiotech Pharmaceuticals, Inc. , please visit our website at http://www.angiotech.com/.
Note on Forward-Looking Statements:
Statements contained in this press release or in our other written or oral public communications that are not based on historical or current fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimate," "continue," "anticipates," "intends," "expects", "hopes" and similar expressions, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and constitute "forward-looking information" within the meaning of applicable Canadian securities laws. All such statements are made pursuant to the "safe harbor" provisions of applicable securities legislation.
Such forward-looking statements are based on assumptions that involve known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Forward-looking statements in this release include the statements regarding; the ability of Angiotech to commercialize the Vascular Wrap paclitaxel-eluting mesh for hemodialysis patients, to find other potential uses for the product and the successful initiation, enrolment, completion and outcome of the clinical trials referred to in the press release.
These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others; the timing of, and safety and efficacy results from, the clinical trials referred to in the press release, decisions made by Angiotech based on these results, the ability to obtain regulatory approval to develop and commercialize the product, the ability to manufacture sufficient quantities of product for development and commercialization activities and to do so in a timely and cost efficient manner, the competitive environment for such products, the availability of resources and funding, and the risks and uncertainties associated with the business and described in Angiotech's filings with the United States Securities and Exchange Commission or the Canadian securities regulators.
The forward-looking statements are also based on a number of assumptions, including that the data provided with respect to the prevalence of end-stage renal disease in the U.S., the number of these patients who receive hemodialysis, and the failure rate of synthetic grafts, is accurate.
Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company does not assume the obligation to update any forward-looking statements.
CONTACT: Janet Craig, VP, Investor Relations & Corporate Communications, Angiotech Pharmaceuticals, Inc., (416) 997-9006,
