New treatment aims to improve quality of life for hemodialysis patients
17 August 2006 - 3:00PM
PR Newswire (US)
Vascular Wrap(TM) - Lifespan(R) Graft technology platform expected
to enter clinical trials in both the United Kingdom and United
States VANCOUVER, Aug. 17 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, announced
today that it will begin enrolment in a clinical trial in the
United Kingdom to assess the effectiveness and safety of the
Vascular Wrap(TM) paclitaxel-eluting mesh and Lifespan(R) graft
technology platform in hemodialysis patients. This announcement
comes after Angiotech received a "letter of no objection" from the
Medicine and Healthcare products Regulatory Agency, an executive
agency of the Department of Health in the United Kingdom.
Specifically, 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 those 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
expects to enroll the first patient in the United Kingdom-based
clinical trial in the next eight weeks. 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.
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% of grafts fail within one year and
about 75% 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. "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 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." "The Vascular Wrap paclitaxel-eluting mesh is an
important part of our Vascular franchise," said Dr. William Hunter,
President and CEO of Angiotech Pharmaceuticals, "and 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. "From a business
perspective, the Vascular Wrap paclitaxel-eluting mesh could be an
important product for Angiotech, and one that we are very excited
about," continued Dr. Hunter, "With the potential launch of several
other vascular graft products in the first half of 2007, as well as
the possible approval of products like the Vascular Wrap
paclitaxel-eluting mesh in the next couple of years, we are hoping
to see significant growth in our vascular business." Vascular
Wrap(TM) Paclitaxel-Eluting Mesh/Lifespan(R) Graft Combination
Product Angiotech's Vascular Wrap(TM) paclitaxel-eluting
mesh/Lifespan(R) graft combination product technology is designed
to be used as a port for hemodialysis access or as a bypass for a
blocked artery. It is a combination product consisting of both the
Lifespan graft and the Vascular Wrap paclitaxel-eluting mesh. 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. About the study A multicentre, randomised study to
assess the effectiveness of maintaining patency and safety of the
Vascular Wrap paclitaxel-eluting mesh after surgical implantation
with the Lifespan graft in the upper extremity for hemodialysis
vascular access. The primary objective of this study is to
demonstrate, for the purposes of CE marking, that the primary
patency rate of the Vascular Wrap paclitaxel-eluting mesh (Vascular
Wrap and Lifespan graft combination) is superior to the primary
patency rate of the Lifespan graft alone up to 1 year following
hemodialysis access surgery. There will be 10 centres participating
in the study. 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. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), 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;
financial benefits to Angiotech to be realized in Angiotech's
vascular business, the ability of Angiotech to commercialize the
Vascular Wrap paclitaxel-eluting mesh and to find other potential
uses for the product and the successful initiation, 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 new products, 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 and Corporate Communications,
Angiotech Pharmaceuticals, Inc., (416) 997-9006, DATASOURCE:
Angiotech Pharmaceuticals, Inc. CONTACT: Janet Craig, VP, Investor
Relations and Corporate Communications, Angiotech Pharmaceuticals,
Inc., (416) 997-9006,
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