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Angiotech Pharmaceuticals: Boston Scientific Submits Amended IDE to FDA for U.S. Clinical Trial of Its Paclitaxel-Eluting Coronary Stent System
Business Wire, Feb 20, 2002
Business Editors & Health/Medical Writers
VANCOUVER, British Columbia--(BUSINESS WIRE)--Feb. 20, 2002
Angiotech Pharmaceuticals Incorporated (NASDAQ:ANPI) (TSE:ANP.) was notified today by Boston Scientific Corporation ("BSC") that BSC submitted an amended application to the U.S. Food and Drug Administration (FDA) for approval of an Investigational Device Exemption (IDE) to support a clinical trial of its paclitaxel-eluting coronary stent system.
The application is for the TAXUS IV clinical trial, the fourth in a series of studies designed to collect clinical information on BSC's proprietary technology for reducing coronary restenosis.
The amended application incorporates a number of changes, including a modified clinical trial protocol, as stated by BSC.
BSC 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, Inc. is a Canadian pharmaceutical company dedicated to the development of medical device coatings and treatments for chronic inflammatory diseases through reformulation of the anticancer drug, paclitaxel. Several pharmaceutical therapies are in clinical development: systemic Micellar Paclitaxel (PAXCEED(TM)) for secondary progressive multiple sclerosis (Phase 2), rheumatoid arthritis (Phase 1) and severe psoriasis (Pilot Phase 2). The paclitaxel-coated coronary stent program is currently in international clinical safety and efficacy studies. Other medical device programs include paclitaxel-loaded surgical implants for the treatment of restenosis associated with peripheral vascular surgery.
PAXCEED is a trademark of Angiotech Pharmaceuticals, Inc.
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 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 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 statements contained herein to reflect future results, events or developments.
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