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Angiotech Pharmaceuticals: Boston Scientific Enrolls First Patients In International Drug-Eluting Stent Clinical Trial.


Business Editors

NATICK, Mass.--(BUSINESS WIRE)--July 10, 2001

Angiotech (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:ANPI ANPI Angiotech Pharmaceuticals Inc. (Vancouver, BC, Canada)
ANPI Associazione Nazionale Partigiani d'Italia (Italian: National Association of Partisans) 
)(TSE See Tokyo Stock Exchange.

TSE

1. See Tokyo Stock Exchange (TSE).

2. See Toronto Stock Exchange (TSE).
:ANP ANP atrial natriuretic peptide.

ANP

atrial natriuretic peptide.

ANP Atrial natriuretic peptide, see there
.)

Boston Scientific's Third Paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia);  Drug-Eluting Stent

Clinical Trial is Underway

Trial to support European CE mark application

Angiotech Pharmaceuticals (NASDAQ:ANPI)(TSE:ANP.) was notified today by Boston Scientific Corporation (NYSE NYSE

See: New York Stock Exchange
:BSX BSX Bermuda Stock Exchange
BSX Bandai Satellaview-X
BSX Bicycle Super-X (Cross) 
) that it has begun enrollment in its international TAXUS II drug-eluting stent clinical trial led by principal investigator, Dr. Antonio Colombo, EMO Centro Cuore Colombus, Milan, Italy.

The TAXUS program is a series of studies aimed at collecting clinical information on Boston Scientific's proprietary paclitaxel drug-eluting stent technology for reducing coronary restenosis, the regrowth Re`growth´   

n. 1. The act of regrowing; a second or new growth.
The regrowth of limbs which had been cut off.
- A. B. Buckley.
 of vascular tissue within an artery after angioplasty and stenting. Paclitaxel, the active component of the popular chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V,  Taxol(R), has demonstrated promising results in pre-clinical studies for reducing the processes leading to restenosis. Boston Scientific's paclitaxel-eluting stent technology is designed to provide direct delivery of paclitaxel through a polymer on a stent at the desired location with a very predictable and controlled release to prevent restenosis.

TAXUS II is a 532-patient, multi-center, international study where patients are randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 to receive either a paclitaxel-eluting stent or a bare, stainless steel stainless steel: see steel.
stainless steel

Any of a family of alloy steels usually containing 10–30% chromium. The presence of chromium, together with low carbon content, gives remarkable resistance to corrosion and heat.
 control stent.

In addition to monitoring clinical outcomes, intravascular ultrasound (IVUS IVUS Intravascular ultrasound, see there ) will be used to study safety and performance of two separate dose releases of paclitaxel. The trial is designed to collect critical information for proof of principle and to support regulatory filings for product commercialization in several markets around the world, including a CE Mark in Europe.

"The initiation of our third drug-eluting stent clinical trial marks a pivotal point in our development program," said Jim Tobin, President and Chief Executive Officer of Boston Scientific.

"The foundation was set by long-term animal studies that have identified dose ranges that minimize restenosis and promote vascular healing. We are beginning to gain clinical experience with these doses in larger patient populations and are a step closer to providing physicians with a promising treatment option for restenosis."

Commenting on the TAXUS II trial, Dr. Colombo, the Principal Investigator, said, "The entire interventional cardiology interventional cardiology Cardiology The subspecialty of cardiology dedicated to the diagnosis, medical and mechanical therapy, pre- and post-procedure management of adult patients with acute and chronic forms of cardiovascular disease amenable to catheter-based  community looks forward to rapid completion of this study which will add important clinical data in the battle to prevent restenosis."

Boston Scientific is gaining comprehensive clinical experience with drug-eluting stents. The TAXUS I trial is a 61-patient, randomized safety study evaluating slow dose release formulation. It completed enrollment in February. Thirty-day MACE (major adverse cardiac events) evaluation has been completed in all patients with no adverse events. Six-month angiographic and IVUS follow-up is expected to be complete by the fall.

TAXUS III is a 30-patient registry study examining the feasibility of paclitaxel-eluting stent technology for treatment of in-stent restenosis in-stent restenosis Interventional cardiology Scar-induced reclosure of a previously stenosed coronary artery, a complication seen in ±20% of Pts undergoing stent placement for CAD. See Coronary artery disease, Stent. Cf Late stent thrombosis. . This group represents patients with more complex vascular disease who tend to have an increased probability of restenosis. To date, TAXUS III has enrolled 22 patients. Enrollment is expected to be complete by the end of the summer.

The fourth trial in the TAXUS program, TAXUS IV, is a pivotal study to be based in the U.S. to collect key data to support regulatory filings for U.S. product commercialization. The company expects to begin enrolling patients in a U.S. clinical trial before the end of the year. The comprehensive TAXUS program positions Boston Scientific to launch paclitaxel-eluting stents in Europe in 2002 and in the U.S. in 2003.

Boston Scientific has acquired worldwide co-exclusive rights from Angiotech to use paclitaxel to coat its coronary stent products and other vascular and non-vascular products. Angiotech Pharmaceuticals is a Canadian pharmaceutical company dedicated to the development of medical coatings and treatments for chronic inflammatory diseases through reformulation of the anti-cancer drug, paclitaxel.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

Statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "will," "estimate," "continue," "anticipates," intends," " expects" and words of similar import, constitute "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  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 national 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 securities and Exchange Commission. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statement contained herein to reflect future result, events or developments.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Jul 10, 2001
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