FINAL CLINICAL STUDY DATA PRESENTED TODAY BY DR. MICHAEL DAKE AT
THE TRANSCATHETER CARDIOVASCUALR THERAPEUTICS (TCT) CONFERENCE IN
WASHINGTON, DC
VANCOUVER, Sept. 24 /PRNewswire-FirstCall/ - Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced that
a summary of the final clinical trial results for the randomized
study of Cook Medical's Zilver(R) PTX(R) Drug-Eluting Peripheral
Stent for use in patients with peripheral arterial disease (PAD) in
the superficial femoral artery (SFA) was presented today at the
Transcatheter Cardiovascular Therapeutics (TCT) conference in
Washington D.C. The study - from
the largest clinical trial to ever evaluate the performance of a
drug-eluting stent (DES) in the treatment of peripheral vascular
disease - met its 12-month primary endpoint goals showing
non-inferior event-free survival (EFS) and superior patency for the
Zilver PTX as compared to balloon angioplasty. Cook Medical, a
license holder of Angiotech's paclitaxel technology, has developed
Zilver PTX: a self-expanding, highly durable nitinol stent that
uses a proprietary technology to deliver a locally therapeutic dose
of paclitaxel, a proven anti-restenotic drug, to the target lesion.
The data from this clinical trial supports Cook's PMA application
submitted to the FDA earlier this year.
This multicenter, multinational, prospective, randomized study
compared the safety and effectiveness of the Zilver PTX to balloon
angioplasty and bare metal stenting. Patients with de novo or
restenotic SFA lesions were randomized to balloon angioplasty or
Zilver PTX stent placement. Balloon angioplasty patients
experiencing acute failure ((greater than) 30% residual stenosis)
underwent secondary randomization to provisional stenting with
Zilver BMS (bare metal stent) or Zilver PTX. Endpoints included
event-free survival (EFS), stent integrity by radiographic core
laboratory analysis and primary patency by Duplex ultrasound core
laboratory analysis (peak systolic velocity ratio 55 institutions
in the United States, Japan and Germany, with 241 patients randomized to the
Zilver PTX group and 238 to the balloon angioplasty group.
Demographics and lesion characteristics were similar for both
groups. Approximately half the balloon angioplasty group
experienced acute failure and underwent secondary randomization,
assigning 59 and 61 patients to provisional stenting with Zilver
BMS and Zilver PTX, respectively.
The study met its 12-month primary endpoint by showing
non-inferior EFS and superior patency for the Zilver PTX compared
to balloon angioplasty. There was also significant clinical
improvement in the group receiving Zilver PTX. Angiotech believes
the results of this randomized, multicenter study support the
safety and effectiveness of the Zilver PTX Drug-Eluting Peripheral
Stent.
"These results establish paclitaxel as the only anti-restenosis
drug to ever demonstrate efficacy in the treatment of PAD in a
large, randomized, clinical trial," said Dr. William Hunter, President and CEO of Angiotech.
"We are optimistic that this study will support Cook's application
with the FDA to become the first drug eluting peripheral stent
available for the management of patients suffering from PAD in
the United States."
About Zilver PTX
The Zilver PTX stent was CE Marked in August 2009 and has been made available in
Europe since September of 2009. It
is the first drug-eluting stent indicated for treating PAD in the
SFA, an often difficult-to-treat blood vessel in the leg. Upon
deployment, the Zilver PTX stent expands and holds open the artery
to restore blood flow. It then delivers the drug paclitaxel to the
cells in the vessel wall to reduce the risk of new blockages
forming. Cook licenses the rights to use paclitaxel on peripheral
stents and other non-coronary medical devices from Angiotech. In
the United States, the Zilver PTX
Drug-Eluting Stent is an investigational device not available for
sale at this time.
About PAD
PAD is caused by atherosclerosis - the build-up of fatty
deposits (atheroma) within the lining of the arteries. The most
common symptom of PAD is leg pain during exercise. Over time the
arteries may narrow due to atherosclerosis, resulting in a
reduction in blood flow. Severely reduced blood flow in the limbs
is also known as critical limb ischemia (CLI). It is characterized
by leg pain at rest, non-healing wounds, and gangrene, and may lead
to amputation of the limb.
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for the remainder of 2010 and beyond, our strategies or future
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forward-looking statements and include, among others, the
following: general economic and business conditions in the United States, Canada and the other regions in which we
operate; market demand; technological changes that could impact our
existing products or our ability to develop and commercialize
future products; competition; existing governmental legislation and
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governmental legislation and regulations; availability of financial
reimbursement coverage from governmental and third-party payers for
products and related treatments; adverse results or unexpected
delays in pre-clinical and clinical product development processes;
adverse findings related to the safety and/or efficacy of our
products or products sold by our partners; decisions, and the
timing of decisions, made by health regulatory agencies regarding
approval of our technology and products; the requirement for
substantial funding to conduct research and development, to expand
manufacturing and commercialization activities; and any other
factors that may affect our performance. In addition, our business
is subject to certain operating risks that may cause any results
expressed or implied by the forward-looking statements in this
press release to differ materially from our actual results. These
operating risks include: our ability to attract and retain
qualified personnel; our ability to successfully complete
pre-clinical and clinical development of our products; changes in
our business strategy or development plans; our 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; our ability to obtain rights to
technology from licensors; liability for patent claims and other
claims asserted against us; our ability to obtain and enforce
timely patent and other intellectual property protection for our
technology and products; the ability to enter into, and to
maintain, corporate alliances relating to the development and
commercialization of our technology and products; market acceptance
of our technology and products; our ability to successfully
manufacture, market and sell our products; the availability of
capital to finance our activities; our ability to restructure and
to service our debt obligations; and any other factors referenced
in our other filings with the applicable Canadian securities
regulatory authorities or the Securities and Exchange Commission
("SEC"). For a more thorough discussion of the risks associated
with our business, see the "Risk Factors" section in our annual
report for the year ended December 31,
2009 filed with the SEC on Form 10-K, as amended, and our
quarterly report for the 2nd quarter of 2010 filed with the SEC on
Form 10-Q.
Given these uncertainties, assumptions and risk factors,
investors are cautioned not to place undue reliance on such
forward-looking statements. Except as required by law, 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 press release to reflect future
results, events or developments.
(C)2010 Angiotech Pharmaceuticals, Inc. All Rights Reserved.
About Angiotech
Angiotech Pharmaceuticals, Inc. is a global specialty
pharmaceutical and medical device company. 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: ANPI, TSX: ANP), please visit our website at
www.angiotech.com.
About Cook Medical
Founded in 1963, Cook Medical pioneered many of the medical
devices now commonly used to perform minimally invasive medical
procedures throughout the body. Today, the company integrates
medical devices, drugs and biologics to enhance patient safety and
improve clinical outcomes. Since its inception, Cook has operated
as a family-held private corporation. For more information, visit
www.cookmedical.com.
Zilver PTX is a trademark of William Cook Europe A/S.
SOURCE Angiotech Pharmaceuticals, Inc.
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