Excellent in-stent restenosis clinical trial results reported for TAXUS stent system
12 März 2006 - 4:54PM
PR Newswire (US)
TAXUS trials continue to deliver positive outcomes in complex cases
VANCOUVER, March 12 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP) today announced that
its corporate partner, Boston Scientific Corporation ("BSC") has
announced nine-month data from its TAXUS V ISR (in-stent
restenosis) clinical trial(1). The results demonstrated that
patients treated for in-stent restenosis with the TAXUS(R)
Express2(TM) paclitaxel-eluting stent system achieved superior
outcomes compared to those patients treated with radiation-based
brachytherapy. BSC made the announcement at the i2 Summit held in
conjunction with the annual American College of Cardiology
Scientific Session in Atlanta. "The results of the drug-eluting
stent arm are very impressive given the difficult challenges that
restenotic lesions present," said Gregg W. Stone, M.D., Professor
of Medicine, Columbia University Medical Center in New York and the
trial's Principal Investigator. "The TAXUS V ISR trial clearly
demonstrated that patients with bare-metal stent restenosis had
better outcomes when treated with TAXUS stents as compared to
coronary radiation." The study met its primary endpoint of improved
nine-month target vessel revascularization (TVR), which was
significantly lower in the TAXUS stent group (10.5 percent), as
compared to the control group (17.5 percent). The study
demonstrated a nine-month target lesion revascularization (TLR)
rate of 6.3 percent in the TAXUS stent group, as compared to 13.9
for the control group. The study demonstrated an 11.5 percent rate
of Major Adverse Cardiac Events (MACE) for the TAXUS stent group,
as compared to 20.1 percent rate for the control group. TAXUS V ISR
is a prospective, randomized, open-label, controlled study of 396
patients at 37 sites in the United States designed to assess the
TAXUS stent slow-release formulation paclitaxel-eluting coronary
stent system in reducing in-stent restenosis (the regrowth of
diseased tissue into a previously stented artery) versus
intracoronary brachytherapy (radiation delivered directly to the
lesion). An additional 25 patients were enrolled in a registry arm.
Clinical follow-up included more than 95 percent of the patients
enrolled at nine months. "We are very pleased with the results of
the TAXUS V ISR study, which demonstrated the real strength of our
TAXUS stent platform as evidenced by the superior TVR, TLR, and
MACE in complex lesions as compared to the control group," said
Paul LaViolette, Chief Operating Officer of Boston Scientific.
"TAXUS continues to provide consistent benefits in deliverability
as well as safety in a wide variety of complex cases." The TAXUS V
ISR results are scheduled to be published in the March 15 issue of
The Journal of the American Medical Association (JAMA) with an
advanced posting to its website on March 12 at
http://jama.ama-assn.org/. BSC acquired worldwide exclusive rights
from Angiotech to use paclitaxel to coat its coronary stent
products and has co-exclusive rights to other vascular and
non-vascular products. About Angiotech Pharmaceuticals
Vancouver-based Angiotech Pharmaceuticals, Inc. is a specialty
pharmaceutical company pioneering the combination of pharmaceutical
compounds with medical devices and biomaterials to both create
novel solutions for poorly addressed disease states and improve
surgical outcomes. 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," 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. FOR ADDITIONAL
INFORMATION: --------------------------- Analysts and Investors:
Rui Avelar, Chief Medical Officer Angiotech Pharmaceuticals, Inc.
(604) 221-7676 ext 6933 Media: Colleen Beauregard Waggener Edstrom
Bioscience (503) 443-7863, Email: --------------------------- (1)
CAUTION - The TAXUS(R) Express2(TM) paclitaxel-eluting stent system
is considered investigational in the United States for use in
treating in-stent restenosis and for this indication is limited by
Federal Law to investigational use only. DATASOURCE: Angiotech
Pharmaceuticals, Inc. CONTACT: Analysts and Investors: Rui Avelar,
Chief Medical Officer, Angiotech Pharmaceuticals, Inc., (604)
221-7676 ext 6933; Media: Colleen Beauregard, Waggener Edstrom
Bioscience, (503) 443-7863, Email:
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