Feb 25, 2002
VANCOUVER, British Columbia - Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPI)(TSE:ANP) today announced that it has completed the assessment of their double-blind, randomized, 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 (MRI) 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 (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 (5 PM EST).
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 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 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.
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Cindy Yu, 604/221-7676
Rui Avelar, 604/221-7676
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