Wednesday September 13, 9:14 am Eastern Time
VANCOUVER, B.C.--(BUSINESS WIRE)--Sept. 13, 2000--Angiotech Pharmaceuticals, Inc. (NASDAQ:ANPI - news; TSE:ANP - news) today announced that it has received clearance from the Health Canada Therapeutic Product Program to further extend its Phase 1/2 clinical study of paclitaxel for the treatment of secondary progressive multiple sclerosis (SPMS).
Patients will be eligible to receive Angiotech's Micellar Paclitaxel for ethical and compassionate purposes for an additional year. The Company was also granted an option to offer treatment for a second year thereafter.
The Phase 1/2 clinical study of monthly injections of Micellar Paclitaxel in 29 patients with SPMS was initiated in June 1998. As a result of positive data obtained following the first 6 months of treatment, 22 patients elected to receive an additional 6 months of therapy (the first treatment extension phase) which began in October 1999. All 22 patients entering the first treatment extension phase received a dose of 50 mg/m2 and completed the full six-month course of therapy (i.e. all received a total of 12 monthly treatments; 6 months (plus) 6 months). The results from the treatment extension phase were promising, as patients continued to show favorable trends in both clinical disability and MRI-related outcome measures. These 22 patients will now be eligible to receive another year of treatment with an option to continue for a second year.
"The majority of the patients treated have contacted the investigators at St. Michael's Hospital and expressed a desire to have continued access to the treatment. We feel we have an obligation to these patients and are pleased to be able to offer them an additional year, or potentially two years, of therapy," said Donald Longenecker, Ph.D., Angiotech's President and COO. "We are optimistic that the encouraging results will be maintained and that the patients will continue to benefit from the treatment."
"The treatment extension also provides an opportunity to examine the effects of extended low-dose paclitaxel treatment on both the patients and the disease."
In a separate clinical investigation, Angiotech is continuing to enroll patients in its multi-center, 189-patient, Phase 2 clinical study of paclitaxel for the treatment of SPMS.
Multiple sclerosis is a chronic inflammatory and progressive disease, with debilitating neurological symptoms. It disables patients by disturbing vision, strength, balance and sensation, as well as causing fatigue and cognitive problems. Approximately 40% of all MS patients have secondary progressive multiple sclerosis - the most chronic form of the disease. MS affects as many as 350,000 persons in the U.S. and approximately 8,000 new cases are reported each year. The estimated 1999 U.S. treatment market for MS is US$1.2 billion.
Angiotech Pharmaceuticals, Inc. is a Canadian pharmaceutical company dedicated to the development of medical device coatings and treatments for chronic inflammatory diseases through formulation of the anticancer drug, paclitaxel. Three pharmaceutical therapies are in clinical development: systemic Micellar Paclitaxel for secondary progressive multiple sclerosis (Phase 2) and rheumatoid arthritis (Phase 1) and Topical Paclitaxel Gel for psoriasis (Phase 1). In January 2000, the paclitaxel-coated coronary stent program also entered human studies. Other medical device programs include paclitaxel-loaded surgical implants for the treatment of restenosis associated with peripheral vascular surgery and for the treatment of proliferative ocular conditions.
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without limitation statements containing the words "believes," "may," "will,"
"estimate," "continue," "anticipates," "intends," "expects" and words of
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of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking
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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
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in the Company's filings with the Securities and Exchange Commission. Given
these uncertainties, readers are cautioned not to place undue reliance
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results, events or developments.
Angiotech Pharmaceuticals Inc.
Cathryn E. Hunter, 604/221-7676