Healthcare Industry News: critical limb ischemia
News Release - April 26, 2007
Two-year data for Angiotech's Vascular Wrap(TM) Paclitaxel-Eluting Mesh to be presented at European vascular symposium
STRASBOURG, France and VANCOUVER, April 26 (HSMN NewsFeed) - Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP), a global specialty pharmaceutical and medical device company, announced that the two-year data from its European pivotal trial examining the Vascular Wrap(TM) Paclitaxel-Eluting Mesh ("Vascular Wrap(TM)") will be presented today at a scientific forum in Europe. The two-year study examined the safety and efficacy of the Vascular Wrap(TM) for use in arterial bypass surgery in patients with peripheral arterial disease (PAD). Dr. Lajos Matyas is presenting the results at the 2007 European Symposium of Vascular Biomaterials (ESVB) in Strasbourg, France."We are pleased to have this opportunity to present these encouraging results from our two-year European Vascular Wrap(TM) study to the physicians, researchers and other healthcare professionals at ESVB," said Dr. Rui Avelar, Chief Medical Officer at Angiotech.
"The results of this 109-patient study suggest that the Vascular Wrap(TM) combined with an ePTFE graft may be a promising future therapy option for patients with PAD who require arterial bypass surgery," said Dr. Lajos Matyas, a lead investigator based in Miskolc, Hungary, who enrolled the highest number of patients out of the nine clinical centres in Europe involved in the study.
Angiotech initially released the results from the two-year Vascular Wrap(TM) study in November 2006. The objectives of this two-year study were to assess the safety and clinical performance of the Vascular Wrap(TM) in combination with an ePTFE vascular graft following surgery to treat patients suffering from advanced peripheral arterial disease in their lower limbs. The Vascular Wrap(TM) in combination with an ePTFE graft was compared to a control group of patients that received standard of care - an ePTFE graft alone. Some of the highlights of the two-year study that will be presented at ESVB include:
-Statistically significant difference in a key efficacy measurement:
- The development of neointimal hyperplasia, which is a common
complication of bypass surgery involving a thickening of the
inner layer of the blood vessel, can ultimately result in the
closing of the newly opened or grafted blood vessel and lead to
limb amputation.
- When comparing the treatment arm relative to the control, the
Vascular Wrap(TM) maintained the mean diameter of the distal
anastomosis during the 24-month trial compared to a decrease in
mean diameter in the control arm. This reached statistical
significance at two years (p=0.03). A decrease in mean
diameter of distal anastomosis in the control arm indicates the
development of neointimal hyperplasia.
-The Vascular Wrap(TM) trial produced evidence of improved patient outcomes:
- The trial produced evidence that the Vascular Wrap(TM) reduced the
overall incidence of amputation and prolonged limb retention time.
The control group had an almost 19% higher probability of losing
their limb compared to the treatment arm.
- The treated group had an overall lower incidence of amputations
(15.5%, 11/71 subjects) compared to the control group (18.4%,
7/38 subjects).
- While the sample size was small, diabetic subjects appeared to
experience benefits from the Vascular Wrap, which was associated
with a 41.3% reduction in the incidence of amputations. The
treated group of diabetic subjects had a lower incidence of
amputations (13.8%, 4/29 diabetic subjects) compared to the
control group (23.5%, 4/17 diabetic subjects).
-The trial results produced evidence that the Vascular Wrap(TM) is well tolerated:
- Adverse events (AE) leading to death occurred in a lower
percentage of treated subjects (11%, 8/71 subjects), than in
controls (18%, 7/38 subjects).
- The incidences of adverse events and serious adverse events were
comparable in treated (graft with Vascular Wrap) and control
(graft alone) groups.
- No adverse events were considered by the investigators to be
related to the use of the Vascular Wrap.
- Overall, the action taken to resolve AEs was similar for the two
groups, and the outcomes were comparable.
About the Study
This single-blind study enrolled a total of 109 patients at nine clinical centres in Europe as well as the Dutch Antilles and randomized patients with peripheral vascular disease in a 2:1 fashion. The treatment arm enrolled patients with a synthetic bypass graft plus the Vascular Wrap(TM) paclitaxel-eluting mesh and the control arm enrolled patients with a synthetic bypass graft alone.
About peripheral arterial disease (PAD)
Peripheral vascular disease, especially peripheral arterial disease (PAD) is a prevalent cause of morbidity and mortality among the aging population worldwide. Artery stenosis or occlusion causes reduced blood flow, decreased mobility, and limb loss in the later disease stages. Population surveys in Europe and the U.S. estimate that PAD prevails in 10-25% of the population; most surveys give a prevalence of 20% for lower extremity PAD in the overall population. The major cause of PAD is atherosclerosis, in which deposits narrow and eventually occlude the arteries. The disease progresses in the lower extremities to critical limb ischemia (CLI), characterized by leg pain at rest, skin ulceration, gangrene, and ultimately amputation. Among patients diagnosed with CLI, 25% may require amputation within a year.
Limb salvage depends on restoring and maintaining blood flow in the CLI patient. Surgical interventions include endovascular therapy (angioplasty and stenting). However, in patients with severe occlusion and stenosis, small vessel occlusion, calcified lesions, as well as those with diabetes, surgical bypass provides a final option to manage the occlusion(s) prior to amputation. The success of grafting to restore blood flow depends on inflow and outflow of the graft. The trial results show trends that suggest that the use of the Vascular Wrap(TM) in these procedures may increase the success rates of vascular graft surgery.
Vascular Wrap(TM) Paclitaxel-Eluting Mesh/ePTFE Graft Combination
Product
Angiotech's Vascular Wrap(TM) paclitaxel-eluting mesh/ePTFE graft combination product technology is designed to and in development for use in hemodialysis access and peripheral arterial bypass surgery. It is a combination product consisting of both the ePTFE graft and the Vascular Wrap(TM) paclitaxel-eluting mesh. The Vascular Wrap(TM) component is a biodegradable mesh implant incorporating Angiotech's paclitaxel technology in a novel biomaterial with the goal of mitigating scar formation caused by abnormal blood flow thereby potentially enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.
Note on Forward Looking Statements:
Statements contained in this press release that are not based on historical fact, including without limitation statements containing the words "believes," "may," "could", "plans," "will," "estimate," "continue," "anticipates," "intends," "expects" 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. Forward-looking statements may involve, but are not limited to, comments with respect to our objectives and priorities for 2006 and beyond, our strategies or future actions, our targets, expectations for our financial condition and the results of, or outlook for, our operations, research development and further product and drug development. Such forward-looking statements also 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. Such factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: general economic and business conditions, both nationally and in the regions in which we operate; technological changes that impact our existing products or our ability to develop and commercialize future products; competition; changes in business strategy or development plans; the ability to attract and retain qualified personnel; existing governmental regulations and changes in, or the failure to comply with, governmental regulations; adverse results or unexpected delays in drug discovery and clinical development processes; failure to obtain patent protection for discoveries; loss of patent protection resulting from third party challenges to our patents; commercialization limitations imposed by patents owned or controlled by third parties; dependence upon, and relationships with strategic alliance partners to develop and commercialize products and services based on our work; our ability to obtain rights to technology from licensors; liability for patent claims and other claims asserted against us; the requirement for substantial funding to conduct research and development and to expand commercialization activities or consummate acquisitions; the size of the market and the potential market for our products in specific disease areas, including peripheral arterial disease, other factors referenced in our annual information form and other filings with the applicable Canadian securities regulatory authorities or the Securities and Exchange Commission; and any other factors that may affect performance.
In addition, our business is subject to certain operating risks that may cause the actual results expressed or implied by the forward-looking statements in this report to differ materially from our actual results. These operating risks include: our ability to successfully complete preclinical and clinical development of our products; the ability to obtain and enforce timely patent and other intellectual property protection for our technology and products; decisions, and the timing of decisions, made by health regulatory agencies regarding approval of our technology and products; the ability to complete and maintain corporate alliances relating to the development and commercialization of our technology and products; market acceptance of our technology and products; the competitive environment and impact of technological change; the continued availability of capital to finance our activities; our ability to integrate into our business the operations of AMI; and, our ability to achieve the operational and other synergies and the other commercial or financial benefits expected as a result of the acquisition of AMI.
Given these uncertainties, assumptions and risk factors, readers are cautioned not to place undue reliance on such forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained in this report to reflect future results, events or developments.
Vascular Wrap(TM) is a trademark of Angiotech Pharmaceuticals, Inc.
© 2007 Angiotech Pharmaceuticals, Inc. All rights reserved.
Source: Angiotech Pharmaceuticals
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