Tuesday November 16, 8:32 am Eastern Time
Company Press Release
VANCOUVER, British Columbia--(BUSINESS WIRE)--Nov. 16, 1999-- Angiotech(TSE:ANP. - news) Angiotech Pharmaceuticals, Inc. (TSE:ANP - news) announced today that it has initiated a Phase II clinical study for the use of Micellar Paclitaxel in the treatment of patients with secondary progressive multiple sclerosis (SPMS) - a condition which currently has no approved treatment in the U.S.
The double-blind, placebo-controlled study plans to enroll 189 patients between the ages of 18 to 55 that present with SPMS. The nine-month study will be conducted at seven centers across Canada.
``Multiple sclerosis is the most disabling disease of the human nervous system and SPMS is the most severe form. About 40% of all MS patients suffer from this condition and we are hopeful that our Micellar Paclitaxel therapy will improve the quality of life for a group of patients with few treatment options,'' said William L. Hunter, MD, MSc, Angiotech's Chairman and CEO.
Patients will receive placebo or Micellar Paclitaxel at 50 mg/m (squared) or 75 mg/m (squared) at four-week intervals for a total of six doses (with a 12-week follow-up period). The primary objective of the study will be to determine the difference in new lesion activity in the Micellar Paclitaxel treatment groups relative to the control group during the treatment phase as demonstrated by magnetic resonance imaging (MRI).
Phase I/II clinical study preliminary results announced last month yielded some evidence of Micellar Paclitaxel's effectiveness in SPMS. The data showed that a significant percentage of the 29 patients showed favourable trends in Expanded Disability Status Scale (EDSS) score, MS functional scores, quality of life and MRI burden of disease. A majority of these patients remain on therapy and further results should be available in early 2000.
``In the first study, patients treated with 50 mg/m (squared) Micellar Paclitaxel (approximately one-fifth of the chemotherapy dose) showed a significant reduction of disease progression using MRI,'' said Ann Marie Oktaba, MSc, Director, Clinical and Regulatory Affairs of Angiotech. ``This Phase II study should determine whether Micellar Paclitaxel can slow the progression of SPMS in a large sampling of patients.''
Multiple sclerosis is a chronic inflammatory and progressive disease, with debilitating neurological symptoms occurring over a period of several years. Although the disease does not result in early death, it disables patients by disturbing vision, strength, balance and sensation, as well as causing fatigue and cognitive problems. The estimated 1999 U.S. treatment market for all MS patients is US$891 million.
Angiotech Pharmaceuticals, Inc. is a Canadian pharmaceutical company dedicated to the development of medical device coatings and treatments for chronic inflammatory diseases through the reformulation of the anticancer drug, paclitaxel. Three therapies are in clinical development: systemic Micellar Paclitaxel for rheumatoid arthritis, systemic Micellar Paclitaxel for MS and Topical Paclitaxel Gel for psoriasis. Other programs include paclitaxel-coated stents and implants used in peripheral vascular surgery for the prevention or treatment of stenosis.
For enrollment criteria and study site details, please call Angiotech's Clinical Study Information Line at 1-888-952-6446, or visit our website at www.angiotech.com.
Angiotech Pharmaceuticals Inc.
Cathryn E. Bowden, 604/221-7676