Angiotech Pharmaceuticals, Inc.: Phase 2 Multiple Sclerosis Trial Fails to Meet Primary Objective.Business Editors & Health/Medical Writers VANCOUVER, British Columbia--(BUSINESS WIRE)--Feb. 25, 2002 Angiotech Pharmaceuticals, Inc. (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)(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 ) today announced that it has completed the assessment of their double-blind, 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. , placebo-controlled Phase 2 MS study conducted at 9 centers across Canada. A total of 174 patients completed the full course and received either placebo or PAXCEED(TM) at 50 mg/m2 or 75 mg/m2 every 4 weeks for a total of six doses (with a 12-week follow-up period). The primary objective was to determine the difference in new lesion activity by magnetic resonance imaging magnetic resonance imaging (MRI), noninvasive diagnostic technique that uses nuclear magnetic resonance to produce cross-sectional images of organs and other internal body structures. (MRI 1. (application) MRI - Magnetic Resonance Imaging. 2. MRI - Measurement Requirements and Interface. ) in the PAXCEED(TM) treatment groups relative to the control group during the treatment phase. Clinical end points were also measured, including the Expanded Disability Status Scale The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis.[1] The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. (EDSS). The study failed to meet statistical significance in its primary MRI objective. The more detailed results of the trial will be discussed at an analyst conference call today at 2 PM PST PST Paroxysmal supraventricular tachycardia, see there (5 PM EST EST electroshock therapy. EST abbr. electroshock therapy ). The Phase 2 study was based on positive data obtained in Phase 1 including 2 treatment extension phases, the latest of which showed that 83% of patients either stabilized or improved at the 3 year follow-up point. "We are obviously disappointed that the primary objective of the study was not met," said William Hunter, MD, MSc, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Angiotech. "As a result, we believe that pursuing a Phase 3 study in this patient population would present an unacceptable risk to Angiotech and its shareholders and does not warrant the significant time and financial expense involved. However, we are encouraged by the impressive safety profile of the drug at higher doses than previously tested which we believe will assist us in the further development of other programs." Live audio and slideshow presentation of the results will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public. Access to live and replay audio-visuals of the conference call will be available two hours following the completion of the call at www.angiotech.com. A recording of the call will also be available until Monday, March 4, 2002 by calling 800/552-5253 and entering Access Code #20376528. Multiple Sclerosis (MS) is a chronic inflammatory disease of the central nervous system that debilitates 1 million people worldwide each year. MS cripples the patient by disturbing vision, coordination and strength; it affects their ability to walk, use their hands and speak. The disease may also cause extreme fatigue, incontinence, spasticity and sensory deficits. Patients may feel numbness and tingling Numbness and Tingling Definition Numbness and tingling are decreased or abnormal sensations caused by altered sensory nerve function. Description The feeling of having a foot "fall asleep" is a familiar one. in the limbs that, in later stages, may lead to paralysis. The 2001 treatment market for MS patients worldwide was US$2.3 billion, and is expected to grow 12%-15% per year over the next 3 to 4 years. 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 paclitaxel. Several pharmaceutical therapies are in clinical development and the paclitaxel-coated coronary stent program is currently in multiple international clinical studies. Other medical device programs include paclitaxel-loaded surgical implants. 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 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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