Angiotech partner to begin first U.S. clinical trial of a drug-eluting non-coronary stent
28 Juli 2004 - 2:00PM
PR Newswire (US)
Angiotech partner to begin first U.S. clinical trial of a
drug-eluting non-coronary stent VANCOUVER, July 28
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc. (NASDAQ:
ANPI; TSX: ANP) corporate partner Cook Incorporated, announced
today that Cook will begin the first U.S. clinical trial of a
drug-coated stent for a peripheral (non-coronary) artery. The study
will examine whether drug-coated stents, which have shown clinical
success in treating coronary artery disease, can have similar
benefits in treating peripheral vascular disease. Cook's DESTINY
trial (Drug-Eluting StenT IN the SFA/Fempop ArterY) is the first
clinical investigation approved by the U.S. Food and Drug
Administration to study the effectiveness of a drug-eluting stent
for a peripheral artery. The DESTINY trial will investigate the use
of the Zilver(R) PTX paclitaxel-eluting stent in the above-the-knee
femoropopliteal artery, Cook officials reported. It will be
conducted initially at ten U.S. medical facilities and will enroll
60 patients, with an expanded trial likely pending further FDA
review. Cook expects to enroll its first patient in the DESTINY
trial in September. "This is one of the most anticipated trials in
years," said the DESTINY trial's national principal investigator
Michael D. Dake, M.D., chief of cardiovascular and interventional
radiology at Stanford University School of Medicine. "There is
tremendous investigator enthusiasm for DESTINY to determine if
benefits comparable to those achieved in patients with coronary
lesions can be obtained by translating similar drug-eluting stent
technology to symptomatic individuals with peripheral arterial
disease." Like the arteries feeding the heart muscle, arteries in
other areas of the body can narrow due to vascular disease and
become partially or fully blocked, a condition called stenosis.
Using a small balloon inflated inside the artery at the site of the
blockage, physicians can open many blockages in a procedure called
an angioplasty. But, much like coronary arteries can redevelop
health-threatening blockages in a process called restenosis,
peripheral arteries also may close again months or years following
angioplasty. Stents, small metal devices that act like scaffolds to
prop open blocked arteries, have become enormously successful at
reducing the rate of restenosis in both coronary and peripheral
arteries. But even these advanced devices sometimes cannot hold
open an artery as it forms new blockages. For heart patients, the
advent of stents coated with drugs to retard or eliminate the
metabolic processes that cause blockages to return has proven
enormously successful, making these devices among the great medical
success stories of recent years. The DESTINY trial will examine
whether the Zilver PTX self-expanding vascular stent coated with an
anti-tumor agent called paclitaxel can provide clinical benefit to
patients receiving stents in the femoropopliteal artery, Cook
officials explained. The Zilver PTX Peripheral Stent is an
investigational device not approved for sale in the United States.
With international headquarters in Bloomington, Ind., privately
held COOK(R) (http://www.cookgroup.com/) is a leading designer,
manufacturer and global distributor of minimally invasive medical
device technology for diagnostic and therapeutic procedures. Since
its founding in 1963, Cook has created innovative technologies for
stents and stent-grafts, catheters, wire guides, introducer needles
and sheaths, embolization coils, medical biomaterials, vena cava
filters and other minimally invasive medical devices for radiology,
cardiology, urology and OBN/GYN, critical care medicine, surgery,
gastroenterology, bone access and endovascular therapies.
Vancouver-based Angiotech Pharmaceuticals, Inc., a specialty
pharmaceutical company focusing on drug-coated medical devices and
biomaterials, is dedicated to enhancing the performance of medical
devices and biomaterials through the innovative uses of
pharmacotherapeutics. To find out more about Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP), please visit our
website at http://www.angiotech.com/. Statements contained herein
that are not based on historical or current fact, including without
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"believes," "may," "continue," "estimate," "expects," "may" and
"will" and words of similar import, constitute "forward-looking
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Litigation Reform Act of 1995. Such forward-looking statements
involve known and unknown risks, uncertainties and other factors
that may cause the actual results, events or developments to be
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developments expressed or implied by such forward-looking
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general economic and business conditions, both nationally and in
the regions in which the Company operates; technology changes;
competition; changes in business strategy or development plans; the
ability to attract and retain qualified personnel; existing
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against the Company; and other factors referenced in the Company's
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or the Canadian securities regulators. 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. FOR ADDITIONAL
INFORMATION: Rui Avelar (Investors) (604) 221-7676 ext 6996 Eric
Starkman, Starkman & Associates (Media) (212) 252-8545 ext 12
DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT: Rui Avelar
(Investors), (604) 221-7676 ext 6996; Eric Starkman, Starkman &
Associates (Media), (212) 252-8545 ext 12
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