More MS news articles for Nov 2001

Angiotech Extends Its Phase 2 Study Of Multiple Sclerosis

NOVEMBER 26, 2001 - 08:01 EST

VANCOUVER, BRITISH COLUMBIA--Angiotech Pharmaceuticals Incorporated (NASDAQ:ANPI; TSE:ANP) today announced that it has received clearance from the Health Canada Therapeutic Products Directorate to extend its study to assess the safety and efficacy of PAXCEED(TM), Angiotech's proprietary systemic formulation of Micellar Paclitaxel, in the treatment of secondary progressive multiple sclerosis (SPMS) for another year. Approximately 100 patients will be enrolled in this extended study, and all patients treated in Phase 2 will have the option of continuing treatment. To date, there have been no drug-related unexpected and serious adverse events reported in the Phase 2 study.

Patients in this 1-year, open-label, extended Phase 2 study will all receive a 75 mg/m(2) dose of PAXCEED(TM) every four weeks for a total of 12 doses. Patients will only receive premedication prior to the first 3 treatments rather than every treatment, as in the Phase 2 study. The primary objective of this study is to assess the safety of PAXCEED(TM) with and without premedicatons. Pharmacokinetic (PK) analysis is also being assessed to determine the paclitaxel dose levels in the body. Screening for patients is expected to begin in December of 2001.

"We are optimistic that the encouraging results from our Phase 1 study, which was twice extended, and the positive safety profile of the Phase 2 study will be maintained and patients will continue to benefit from our treatment," said Ann Marie Oktaba, MSc, Director, Clinical & Regulatory Affairs.

Enrollment for Angiotech's initial Phase 2 study of SPMS was completed in March of 2001. This double-blind, placebo controlled study is being conducted at 9 centers across Canada. The primary objective is to determine the difference in new lesion activity in the PAXCEED(TM) treatment groups relative to the control group during the treatment phase, as demonstrated by magnetic resonance imaging (MRI). Patients received a placebo or PAXCEED(TM) at 50 mg/m(2) or 75 mg/m(2) every 4 weeks for a total of six doses (with a 12-week follow-up period). The treatment phase is now complete and results from this study are expected in early 2002.

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 estimated 2000 treatment market for MS patients worldwide is US$1.8 billion, which is expected to grow 15% a 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 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.

(1) 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.


Angiotech Pharmaceuticals Inc.
Cindy Yu
Corporate Communications Manager
(604) 221-7676
(604) 221-2330  (FAX)