Angiotech's corporate partner, Cook Medical, announces enrollment in pivotal study of paclitaxel-coated stent for use outside th
18 Juli 2007 - 11:57PM
PR Newswire (US)
VANCOUVER, July 18 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), a global
specialty pharmaceutical and medical device company, along with its
corporate partner, Cook Medical Inc., announced that the first U.S.
patients in the pivotal approval trial of a potentially
revolutionary new type of drug-eluting stent designed to prevent
blockages in arteries outside the heart were treated at Tri-City
Medical Center in Oceanside, California. The patients were treated
by principal investigator Dr. Richard Saxon, assistant clinical
professor of radiology at University of California, San Diego, as
part of the international Zilver PTX Stent Trial. "Building on the
success of our paclitaxel-eluting coronary stents, it is rewarding
to see how our technology continues to be leveraged in other
vascular indications. The Zilver PTX may offer another treatment
option for patients who suffer from peripheral arterial disease,"
said Dr. William Hunter, President and CEO of Angiotech. The
pivotal trial is intended to evaluate paclitaxel-eluting stents in
treating peripheral arterial disease (PAD), a serious medical
condition that affects more than 10 million Americans each year.
The study will determine if the same type of drug-eluting
technology found in popular drug-coated stents used to treat
blockages in the coronary arteries can be used to treat blockages
in arteries outside the heart. Following successful safety testing
during the trial's Phase I enrollment, Cook will enroll over 700
patients in the pivotal trial that will be used to support
submission to the U.S. Food and Drug Administration for approval to
market the device. The Zilver PTX Stent Trial is being conducted at
28 U.S. locations and is the first medical device trial ever
conducted simultaneously in the U.S. and Japan. Clinical data
collected on Japanese and U.S. patients will be combined for the
final evaluation of the device and used for regulatory submissions
in both markets for approval. The trial will enroll patients who
will be randomized to receive either the Zilver PTX stent or
balloon angioplasty. About Zilver PTX Cook Medical's Zilver PTX, a
self-expanding nitinol stent, uses a proprietary, polymer-free
technology to coat the device with paclitaxel, an antiproliferative
drug that has been used successfully to reduce the risk of
renarrowing of arteries following angioplasty. In many cases, PAD
patients who have been treated with balloon angioplasty and
stenting experience restenosis, or renarrowing of the arteries,
over time and must undergo more invasive treatment such as bypass
surgery to reopen the arteries. The Zilver PTX trial will determine
whether the combination of the stent and paclitaxel will keep
arteries open over time. About Peripheral Artery Disease (PAD)
Peripheral Artery Disease (PAD) affects blood vessels that lead
from the heart to other areas of the body, such as the legs, feet
and kidneys. When the blood vessels become blocked due to the
build-up of fatty deposits, blood circulation is restricted.
Untreated, PAD results in pain when walking and can lead to
gangrene and amputation. 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," "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. 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 forward-looking statements. Many such risks,
uncertainties and other 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;
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; decisions, and the timing of decisions, made by health
regulatory agencies regarding approval of our technology and
products and decisions regarding reimbursement where applicable;
the requirement for substantial funding to conduct research and
development and to expand commercialization activities; 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; poor performance of the
product in the clinical setting; adverse events related to the use
of the product; improper estimation of the size of the product
markets; adverse results or unexpected delays in clinical
development processes; our ability to attract and retain qualified
personnel; our ability to successfully complete preclinical 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; our ability to
continue to integrate into our business the operations of American
Medical Instruments Holdings, Inc. and our ability to achieve the
operational and other synergies and the other commercial or
financial benefits expected as a result of that acquisition; and
any other factors referenced in our annual information form and
other filings with the applicable Canadian securities regulatory
authorities or the SEC. 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 prospectus to reflect future results, events or developments.
Cook Medical is a co-exclusive licensee to Angiotech's proprietary
paclitaxel technology for use in certain peripheral vascular and
non-vascular fields of use. 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: Jodi
Regts, Manager, Investor Relations and Corporate Communications,
Angiotech Pharmaceuticals, Inc., (604) 221-7930, DATASOURCE:
Angiotech Pharmaceuticals, Inc. CONTACT: Jodi Regts, Manager,
Investor Relations and Corporate Communications, Angiotech
Pharmaceuticals, Inc., (604) 221-7930,
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