First U.S. drug-eluting stent trial to treat peripheral arterial disease enrolls first patient at Stanford University Medical Ce
23 März 2005 - 8:52PM
PR Newswire (US)
First U.S. drug-eluting stent trial to treat peripheral arterial
disease enrolls first patient at Stanford University Medical Center
- New treatment could benefit millions who suffer from seriously
under-diagnosed disease - VANCOUVER, March 23
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate partner Cook Inc.
("Cook") today announced that the first patient was treated Monday
at Stanford University Medical Center in a landmark clinical trial
evaluating a drug-coated stent from Cook Incorporated for
peripheral arterial disease (PAD), a serious medical condition that
affects more than 10 million Americans each year. The trial is the
first U.S. trial ever to test whether drug-eluting stents, which
have shown clinical success in treating coronary artery disease,
can have similar benefits in treating arteries outside the heart.
The elderly female patient was treated by a team of doctors led by
Michael D. Dake, M.D., Professor and Chairman of the Department of
Radiology at the University of Virginia Health System and national
principal investigator, and Daniel Sze, M.D., Associate Professor
of Radiology at Stanford University Medical Center and principal
investigator for the trial at Stanford. "Drug-eluting stents that
combine a metal scaffold with a drug were first applied in the
heart and the results have been phenomenal," Dake said. "Currently,
drug-eluting stents are the primary therapy for obstruction in the
coronary circulation. And it is hoped similar technology, used in
the legs, will help those who suffer from peripheral arterial
disease." "The patient treated today with the Zilver(R) PTX(TM)
stent underwent surgical aortoilliac revascularization previously,
but still experienced pain after walking one-and-a-half miles,"
Dake said. "We will eagerly anticipate her outcome as we follow her
in the trial." Peripheral arterial disease 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 fatty deposit buildup, blood circulation is restricted.
Untreated, peripheral arterial disease results in pain when walking
and can lead to gangrene and amputation. The trial is designed to
determine the safety and effectiveness of the Zilver(R) PTX(TM)
paclitaxel-eluting stent by Cook Incorporated to clear blockages
above the knee in the femoropopliteal artery (the major artery in
the thigh). The stent, a small metal device that acts like a
scaffold, is used to prop open the blocked arteries. But in many
cases, arteries can become blocked again over time as scar tissue
forms around the implanted stent. To prevent the renarrowing of the
artery, the Zilver PTX is coated with paclitaxel, a drug approved
for clinical use as an anti-cancer agent and used successfully with
coronary stents to reduce the risk of renarrowing of the artery.
The Zilver PTX trial is being conducted initially in 10 U.S.
medical facilities and will enroll 60 patients, with an expanded
trial likely pending further FDA review. The study compares the
safety and effectiveness of the drug-eluting stent to standard PAD
interventions. Cook hopes to complete enrollment in the pilot study
by the end of 2005 and complete enrollment in the pivotal study by
the end of 2006. The trial data will be used to apply for FDA
approval of the device for U.S. sale. Cook Inc. holds a
co-exclusive license from Angiotech for the use of paclitaxel in
the peripheral vascular and gastrointestinal fields of use. "We are
extremely pleased to see paclitaxel making headway in the U.S. for
an entirely new vascular indication," said William L. Hunter, MD.
MSc, President and CEO of Angiotech. "We believe Cook's data with
the Zilver paclitaxel-eluting stent to treat the silent epidemic of
PVD will reinforce the consistent safety and superior efficacy of
paclitaxel in reducing restenosis that we have seen previously in
the coronary arteries." The Zilver PTX stent is an investigational
device not approved for sale in the United States. Peripheral
arterial disease is seriously under-diagnosed and can be a
predictor of an increased risk of cardiovascular disease or stroke.
Risk factors for PAD include smoking, diabetes and high blood
pressure. Stanford University Medical Center integrates research,
medical education and patient care at its three institutions -
Stanford University School of Medicine, Stanford Hospital &
Clinics and Lucile Packard Children's Hospital. For more
information, please visit the Office of Communication & Public
Affairs site at http://mednews.stanford.edu/. Vancouver-based
Angiotech Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on combining pharmaceutical compounds with medical
devices and biomaterials to better address common complications
associated with the implantation of medical devices and the
detrimental effects of various diseases. To find out more about
Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP),
please visit our website at http://www.angiotech.com/. Statements
contained herein that are not based on historical or current fact,
including without limitation statements containing the words
"anticipates," "believes," "may," "continue," "estimate,"
"expects," "may" and "will" and words of similar import, constitute
"forward-looking statements" within the meaning of the U.S. Private
Securities 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 materially different from any future results, events or
developments expressed or implied by such forward-looking
statements. Such factors include, among others, the following:
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
governmental regulations and changes in, or the failure to comply
with, governmental regulations; liability and other claims asserted
against the Company; and other factors referenced in the Company's
filings with the United States Securities and Exchange Commission
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. CONTACTS: Todd
Young, Angiotech Pharmaceuticals (Analysts & Investors) (604)
221-7676 ext 6933 Eric Starkman, Starkman & Associates (Media)
(212) 252-8545 ext 12 DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Todd Young, Angiotech Pharmaceuticals (Analysts &
Investors) (604) 221-7676 ext 6933; Eric Starkman, Starkman &
Associates (Media) (212) 252-8545 ext 12
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