Angiotech announces positive safety data
04 Mai 2005 - 7:00PM
PR Newswire (US)
Angiotech announces positive safety data Six-Month Safety
Assessment Indicates Vascular Wrap(TM) Paclitaxel-Eluting Mesh is
Well Tolerated in Patients With Advanced Disease - VANCOUVER, May 4
/PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) today announced positive
preliminary safety results from its novel and proprietary Vascular
Wrap(TM) paclitaxel-eluting mesh trial. This first-in- man study is
designed to evaluate the safety and performance of a novel and
proprietary drug-loaded Vascular Wrap in the prevention of stenosis
after peripheral bypass surgery. This study randomized patients
with peripheral vascular disease in a 2:1 fashion. The treatment
arm enrolled patients with a synthetic bypass graft plus the
Vascular Wrap paclitaxel-eluting mesh and the control arm enrolled
patients with a synthetic bypass graft alone. Preliminary safety
assessment at six months indicated that the Vascular Wrap was safe
in this high risk patient population. Looking at events that could
potentially be attributed to the use of the Vascular Wrap, no
difference in safety was demonstrated between the two groups. This
single-blind, randomized study enrolled a total of 109 patients at
nine clinical centers in Europe as well as the Dutch Antilles. Two
significant endpoints of death and graft occlusion are described
below:
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Treatment Arm (N(equal sign)71) Control (N(equal sign)38)
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Mortality 5.6% (N(equal sign)4) 13.1% (N(equal sign)5)
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Graft Occlusion (thrombosis) 22% (N(equal sign)16) 28% (N(equal
sign)11)
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"These data show that the Vascular Wrap product is safe at six
months in patients with advanced peripheral artery disease," said
Rui L. Avelar, MD, SVP of Medical Affairs and Communications at
Angiotech. "We hope this novel paclitaxel-eluting mesh will
ultimately serve as an important new solution for patients who have
run out of treatment options." The Vascular Wrap(TM) is applied
around the anastomosis site of a synthetic bypass graft and
delivers drug to the blood vessel wall in a targeted manner to
prevent or reduce the stenosis (narrowing of the blood vessel) that
typically follows this type of surgery. If successful, the Vascular
Wrap could potentially be used in peripheral graft procedures to
prolong the life of grafts and expand the possible application into
other high demand indications with no real solutions, such as AV
anastomosis used for dialysis. Peripheral arterial disease, or PAD,
is a common problem in the United States with over twenty million
Americans suffering from poor blood flow to the legs. PAD is a
common circulation problem that can result from such things as
smoking, genetics, diabetes, and inactivity. The arteries that
carry blood to the legs or arms become narrowed or clogged,
preventing or hampering blood flow to vital structures such as
muscles and nerves. These patients suffer from spectrum of symptoms
ranging from pain with walking to being wheel chair dependant and
severe cases may require amputation. Grafts, which may be either
synthetic or a vein from a patient's own body, are used to "bypass"
these blockages. At present, there are over 250,000 peripheral
bypass procedures performed per year in the United States alone.
Failure rates are reported to be as high as 45 percent at two years
for synthetic graft procedures below the level of the knee. These
grafts fail principally due to stenosis at the bypass connection
site. Aside from the peripheral vasculature, future applications of
the Vascular Wrap paclitaxel-eluting mesh could potentially serve a
role with AV anastomoses in hemodialysis patients of which there
are over 100,000 procedures in the U.S., and CABG procedures of
which there are over 600,000 in the U.S. 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 dramatically 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," "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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