TAXUS V demonstrates excellent safety and efficacy results in most challenging lesions and high-risk patients
06 März 2005 - 4:20PM
PR Newswire (US)
TAXUS V demonstrates excellent safety and efficacy results in most
challenging lesions and high-risk patients - Clinical trial meets
all endpoints, continues unmatched scientific rigor of TAXUS
program - VANCOUVER, BC and ORLANDO, FL, March 6
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate partner, Boston
Scientific ("BSC") today announced nine-month results from its
TAXUS V clinical trial, confirming the safety and efficacy of the
TAXUS(R) Express2(TM) paclitaxel-eluting coronary stent system for
the treatment of coronary artery disease. BSC said that the overall
TAXUS V study met its primary endpoint as well as all secondary
endpoints. TAXUS V expands on the TAXUS IV pivotal trial by
studying a higher-risk patient population, including patients with
small vessels, large vessels and long lesions requiring multiple
overlapping stents - the most challenging lesions and highest-risk
patients ever studied in a randomized, controlled drug-eluting
stent trial in the United States. BSC made the announcement at the
annual American College of Cardiology scientific session in
Orlando. The randomized, double-blind trial enrolled 1,172 patients
at 66 sites in the United States, assessing the safety and efficacy
of a slow-release formulation paclitaxel-eluting coronary stent
system in reducing restenosis in de novo lesions 10 - 46 mm in
length and 2.25 - 4.0 mm in diameter. Positive Safety Data The
results supported safety as demonstrated by low overall rates of
Major Adverse Cardiac Events (MACE) and stent thrombosis. MACE
includes death, myocardial infarction (MI; Q-wave and non-Q-wave)
and target vessel revascularization. The study reported a 15.0
percent overall MACE rate at nine months in the TAXUS group
compared with 21.2 percent in the control bare metal stent group
(p=0.0084), with all other factors, including cardiac death and MI,
comparable to control (cardiac death was 0.5 percent in the TAXUS
group versus 0.9 percent in the control group (p=0.7256), MI was
5.4 percent in the TAXUS group versus 4.6 percent in the control
group (p=0.5853)). This reduction was due to the lower target
lesion revascularization (TLR) rate in the TAXUS group compared
with the control group. In addition, stent thrombosis rates were
identical between TAXUS and control stents (0.7 percent or 4/557
patients in the TAXUS group versus 0.7 percent or 4/562 patients in
the control group), indicating comparable safety of drug-eluting
stents and bare metal stents, as stated by BSC. Excellent
Revascularization Rates The study reported a TLR rate of 8.6
percent in the TAXUS group compared with 15.7 percent in the
control group (P=0.0003). TLR - or retreatment rate - is one of the
most accurate indicators of the performance of drug-eluting stent
technology. The study met its primary endpoint, nine-month target
vessel revascularization (symptom-driven repeat revascularization
of the target vessel, or TVR), which was significantly lower than
the rate for the control group. Reduced Restenosis Rates The study
reported an in-segment (stented vessel segment plus 5 mm beyond
each end of the stent) binary restenosis rate of 18.9 percent in
the TAXUS group compared with 33.9 percent in the control group (P
less than 0.0001) (binary restenosis is defined as 50 percent or
greater vessel re-occlusion). The study reported an in-stent binary
restenosis rate of 13.7 percent in the TAXUS group compared with
31.9 percent in the control group (P less than 0.0001). In
addition, the study found significant improvements in the more
sensitive, quantitative angiographic measurements (in-segment,
in-stent and at the edges), such as in-segment percent diameter
stenosis (33.63 percent in the TAXUS group versus 42.34 percent in
the control group; P less than 0.0001), in-segment minimum lumen
diameter (1.81 mm in the TAXUS group versus 1.57 mm in the control
group; P less than 0.0001) and in-segment late lumen loss (0.33 mm
in the TAXUS group versus 0.60 mm in the control group; P less than
0.0001). "TAXUS V studies a challenging patient population with
multiple, concurrent risk factors including small vessels and long
lesions requiring multiple stents, which has never before been
studied with drug-eluting stents," said Gregg W. Stone, M.D., the
study's Principal Investigator and Professor of Medicine, Columbia
University Medical Center in New York. "The overall study shows
TAXUS stents are safe, with comparable rates of death, MI and stent
thrombosis between TAXUS and bare metal stents. The study further
shows the product is highly effective, with marked reductions in
clinical and angiographic parameters. While there was a small but
elevated rate of non-Q-wave MI in TAXUS patients receiving multiple
overlapping stents compared to control, this was most likely
related to reductions in side branch blood flow and balanced by the
reduction in reintervention of more than 50 percent in the TAXUS
group." "These are compelling findings that further confirm the
safety outcomes of paclitaxel-eluting stent technology compared to
bare-metal stents," said Stephen G. Ellis, M.D., the trial's
Co-Principal Investigator and Director of the Sones Cardiac
Catheterization Laboratories at the Cleveland Clinic. "The overall
MACE rates are particularly low for such a complex set of patients.
TAXUS V breaks new ground in examining this high-risk patient
population." "We congratulate Boston Scientific on the excellent
results demonstrated in Taxus V. BSC has set the bar for
drug-eluting stent studies at a level that no other company has
come close to," said William L. Hunter, MD, MSc, President and CEO
of Angiotech. "In every randomized, controlled, double-blinded
study, BSC has clearly and transparently provided physicians and
patients a full platform of trials that reach the widest range of
patients and lesion types." 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. 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: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 Rui Avelar, Angiotech Pharmaceuticals, Inc.
(Analysts), (604) 221-7676 ext 6996 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; Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts), (604)
221-7676 ext 6996; Eric Starkman, Starkman & Associates
(Media), (212) 252-8545 ext 12
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