Angiotech Pharmaceuticals, Inc. - New study shows that Zilver(R) PTX(TM) effectively treats blockages in critical thigh artery
15 April 2009 - 2:30AM
PR Newswire (US)
VANCOUVER, April 14 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) today
announced its corporate partner, Cook Medical, reported data on
two-year follow up that showed that 82 percent of patients who were
treated with Cook Medical's Zilver(R) PTX(TM) drug-eluting
peripheral stent (DES) were free from reintervention at two-year
follow up. The Zilver PTX Registry study, involving 792 patients
from across the world, is assessing the safety and efficacy of the
Zilver PTX in treating PAD. The most recent results were reported
at the 31st International Symposium: Charing Cross Controversies
Challenges Consensus. "These results are extremely encouraging as
it's the first time paclitaxel-coated stents have been used in the
treatment of blockages in arteries outside the heart," said Zilver
PTX global principal investigator, Dr. Michael Dake, Professor in
the Department of Cardiothoracic Surgery at Stanford University
Medical School and Medical Director of the Cath/Angio Laboratories
at Stanford University Medical Center. "Patients treated with the
Zilver PTX had a very low complication rate and required fewer
reinterventions." Data was compiled at 12 and 24 months for 593
patients and 177 patients respectively from the registry study,
which enrolled a broad spectrum of patients, including those with
complex lesions (e.g., long lesions, total occlusions, in-stent
restenosis). The corresponding event-free survival (EFS) rates were
87 percent and 78 percent, and freedom from TLR (target lesion
revascularization) was 89 percent and 82 percent. Clinical measures
that included ankle-brachial index, Rutherford score, and walking
distance and speed scores showed significant improvement at six and
12 months and were maintained through 24 months. Detailed
evaluation of stent x-rays demonstrated excellent stent integrity
through 12 months, confirming previously published results showing
99 percent completely intact stents with a mean follow up of 2.4
years in the challenging superior femoral artery and popliteal
arteries, including behind the knee locations. One in five in the
65- to 75-year-old age group in the UK* has peripheral arterial
disease (PAD). Yet only a quarter of these people have any symptoms
at all. The 'silent' nature of this condition can result in a
number of patients being diagnosed only when their condition has
progressed to the severe stage. In patients with severe PAD whose
condition is not improving with risk-factor modification, exercise
programs and pharmacological therapy, invasive procedures may need
to be carried out. These procedures include angioplasty, stenting
or surgery. "We are impressed with both the efficacy and durability
demonstrated by the Zilver PTX in the registry study and believe we
will see similar results in the US randomized trial which is
currently ongoing," said Dr. Bill Hunter, President and CEO of
Angiotech. "Our partner, Cook Medical, has been committed to
continually improving the efficacy and safety of peripheral DES and
early results suggest that the self-expanding, Zilver PTX stent
will be an important treatment option for patients with PAD." In
addition to the registry arm of the study, the 480 patient
randomized component is designed to evaluate the Zilver PTX across
45 trial sites in the United States, Japan and Europe. Of the 480
patients enrolled in the randomized study, 240 received the Zilver
PTX DES. Enrollment in the randomized study was completed in 2008.
For more information, please visit http://www.zilverptxtrial.com/.
* Fowkes FGR, Housley E, Cawood EHH, MacIntyre CAA, Ruckley CV,
Prescott RJ. Edinburgh artery study: prevalence of asymptomatic and
symptomatic peripheral arterial disease in the general population.
Int J Epidemiol 1991;20:384-91. Cook licenses the rights to use
paclitaxel with peripheral stents and other non-coronary medical
devices from Angiotech. Under the terms of its 1997 license
agreement with Cook, Angiotech is entitled to ereceive royalty
payments upon the commercial sale of paclitaxel-eluting peripheral
vascular products, including the Zilver PTX. Forward Looking
Statements -------------------------- Statements contained in this
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"intends," "expects" and similar expressions, constitute
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respect to our objectives and priorities for 2009 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, product and drug development.
Such forward-looking statements 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
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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; market
demand; technological changes that could impact our existing
products or our ability to develop and commercialize future
products; competition; existing governmental regulations and
changes in, or the failure to comply with, governmental
regulations; 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 and to expand manufacturing and
commercialization activities or consummate acquisitions; 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 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 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 continued
availability of capital to finance our activities; and any other
factors referenced in our other filings with the Securities and
Exchange Commission ("SEC") and applicable Canadian regulatory
authorities. 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, 2008 filed with the SEC on
Form 10-K. Given these uncertainties, assumptions and risk factors,
readers 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)2009 Angiotech Pharmaceuticals,
Inc. All Rights Reserved. About Angiotech Pharmaceuticals 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/. DATASOURCE:
Angiotech Pharmaceuticals, Inc. CONTACT: DeDe Sheel, Investor
Relations and Corporate Communications, Angiotech Pharmaceuticals,
Inc., (415) 293-4412,
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