Angiotech Completes Enrollment of Paclitaxel-Loaded Vascular Wrap Study
10 Juni 2004 - 4:00PM
PR Newswire (US)
Angiotech Completes Enrollment of Paclitaxel-Loaded Vascular Wrap
Study Study to be Further Expanded to Examine Different Patient
Groups VANCOUVER, June 10 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP), today announced
that it has completed the enrollment of its vascular wrap study,
approximately 6 months earlier than anticipated. Patients suffering
from poor blood flow to the legs often have surgery to "by-pass"
the plaque that obstructs the artery. Typically a vein, artery or
synthetic graft is sewn into the blocked artery in front of, and
just beyond the obstruction, allowing blood flow to circumvent the
diseased area. Unfortunately, the sites where the graft is attached
to the artery (called the "anastomosis") are subject to scaring and
narrowing ("stenosis"), leading once again to compromised blood
flow and causing pain, disability or even loss of the limb.
Angiotech has developed a novel treatment solution to prevent the
obstructing scar from forming at the site of the by-pass
connection. Based on the same technology and drug platform as the
TAXUS(TM) coronary stent - the most widely used interventional
treatment of heart disease in the United States - involves placing
an implant containing paclitaxel around the anastomosis during
by-pass surgery to deliver sufficient drug to prevent scar
formation. The present study involves the placement of paclitaxel
wraps around the distal anastomosis (i.e. the anastomosis
downstream from blockage or the one farthest down the leg) in
patients needing implantation of a synthetic (plastic) by-pass
graft. Grafts fail up to 70% of the time within 2 years of by-pass
surgery due to stenosis and clot formation, especially when blood
flow obstructions below the knee are treated with synthetic by-pass
grafts. Overall, peripheral vascular disease (PVD) is a common
problem in the United States with over eight million Americans
suffering from poor blood flow to the legs. "We have been highly
encouraged by the vascular surgeon's enthusiasm for utilizing the
paclitaxel wrap in these very difficult to manage patients," said
William Hunter, MD, President and CEO of Angiotech. "Many of these
patients have aggressive peripheral vascular disease because of
diabetes, and are considered to be at the highest risk for by-pass
failure and limb amputation. Our paclitaxel-loaded wrap allows the
vascular surgeon access to the same sophisticated technology that
is now being widely exploited by interventional cardiologists
worldwide." The original 60-patient, first-in-man, open-label,
randomized study included four sites. The study has now been
expanded to 12 clinical centers and will enroll an additional 20
patients in Europe and the Dutch Antilles to allow a subset
evaluation of patients undergoing above-the knee and below-the knee
by-pass. Patients receiving a peripheral arterial by-pass using a
synthetic graft are randomized to receive a drug-loaded wrap or
no-wrap (the present standard of care). Patients will be examined
at regular intervals for up to two years with ultrasound to measure
blood flow at the by-pass sites. An independent contract research
organization is conducting the study and clinical results are
expected to be available in late 2005. Should the expanded trial
results be favorable, the data will be used to support the
submission of a CE Mark filing (European commercial approval).
Should the paclitaxel wrap prove to be effective in the current
study, the product could be developed for additional uses in
broader applications where no real clinical solutions exist today.
Examples include: above and below the knee by-pass surgery using
vein, coronary by-pass grafting and aterio-venous fistulas; the
lifeline for dialysis patients. Worldwide incidence of these types
of vascular surgery interventions exceeds 1.5 million procedures
annually. 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)(TSE: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. FOR ADDITIONAL
INFORMATION: --------------------------- Analysts: Rui Avelar,
Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6996 Investors:
Ian Harper, Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6933
Media: Eric Starkman, Starkman & Associates (212) 252-8545 ext
12 DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT: Analysts:
Rui Avelar, Angiotech Pharmaceuticals, Inc., (604) 221-7676 ext
6996; Investors: Ian Harper, Angiotech Pharmaceuticals, Inc., (604)
221-7676 ext 6933; Media: Eric Starkman, Starkman & Associates,
(212) 252-8545 ext 12
Copyright
Angiotech Pharmaceuticals - Common Shares (MM) (NASDAQ:ANPI)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
Angiotech Pharmaceuticals - Common Shares (MM) (NASDAQ:ANPI)
Historical Stock Chart
Von Jul 2023 bis Jul 2024