Angiotech initiates European trial examining the Vascular Wrap(TM) paclitaxel-eluting mesh for Dialysis Patients with End-Stage
29 Mai 2007 - 11:15PM
PR Newswire (US)
VANCOUVER, May 29 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, today
announced the initiation of a European study evaluating the safety
and efficacy of the Vascular Wrap(TM) paclitaxel-eluting mesh
("Vascular Wrap(TM)") after surgical implantation with an ePTFE
vascular graft in the upper extremity for hemodialysis vascular
(AV) access. "Patients with end-stage renal disease today face the
high probability that their AV graft will fail within the first
year of use. The Vascular Wrap (TM) product has the potential to
save these dialysis patients from the further health and financial
burdens of repeated surgeries and additional hospitalizations,"
said Dr. Eric Chemla, coordinating investigator of the study based
at St. George's Healthcare NHS Trust in London, UK. "We believe
that the Vascular Wrap(TM) product will be a key catalyst for
building out an Angiotech-branded, vascular franchise. We expect
that the results from this European study and the ongoing U.S.
pivotal trial will form the groundwork for expanding the potential
indications for the Vascular Wrap (TM) technology," said Dr.
William Hunter, President and CEO of Angiotech. The European (AV)
study will involve approximately 198 patients at 20 centres in
Europe. The first patient was enrolled by Dr. Ali Bakran at the
Royal Liverpool University Hospital. Within one year following
vascular access surgery, the patency of the Vascular Wrap(TM)
combined with an ePTFE vascular graft will be compared to a control
group of patients who receive the standard of care, which is an
ePTFE vascular graft alone. In March 2007, Angiotech launched a
similar pivotal trial in the United States, which is also designed
to evaluate the safety and efficacy of the Vascular Wrap(TM) after
surgical implantation with an ePTFE vascular graft in the upper
extremity for AV access. In November 2006, Angiotech reported
results from its European first-in-man study examining the safety
and clinical performance of the Vascular Wrap(TM) when used to
treat patients suffering from advanced peripheral arterial disease
(PAD) in their lower limbs. Based on the strength of this two-year
data, Angiotech submitted an application for a CE Mark for its
Vascular Wrap(TM) paclitaxel-eluting mesh/ePTFE vascular graft
combination product for this indication. Upon receipt of a CE Mark,
Angiotech would commence commercialization of its Vascular Wrap(TM)
product in the EU and certain other countries outside of the United
States. About the European (AV) Study The European (AV) study is a
multi-centre, randomized, single-blind study to assess the safety
and effectiveness of the Vascular Wrap(TM) after surgical
implantation with an ePTFE vascular graft in the upper extremity
for hemodialysis vascular (AV) access. It is expected that results
from this study will serve as a base of European experience for CE
Mark submission, along with supporting data from the U.S. pivotal
trial. 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 2007 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, 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. (TM)
Vascular Wrap is a trademark of Angiotech Pharmaceuticals, Inc. (C)
2007 Angiotech Pharmaceuticals, Inc. All rights reserved. About
Angiotech Angiotech Pharmaceuticals, Inc. is a global specialty
pharmaceutical and medical device company with 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
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. CONTACT: Janet Craig, VP, Investor
Relations and Corporate Communications, Angiotech Pharmaceuticals,
Inc., (604) 221-6933, ; Jodi Regts, Manager, Investor Relations and
Corporate Communications, Angiotech Pharmaceuticals, Inc., (604)
221-7930, DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT:
Janet Craig, VP, Investor Relations and Corporate Communications,
Angiotech Pharmaceuticals, Inc., (604) 221-6933, ; Jodi Regts,
Manager, Investor Relations and Corporate Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-7930,
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