VANCOUVER, B.C. -- February 28, 2000 -- Angiotech Pharmaceuticals, Inc. announced encouraging preliminary results from the treatment extension phase of its Phase I/II clinical study of paclitaxel for the treatment of secondary progressive multiple sclerosis.
In October 1999, Angiotech reported data at the American Neurological Association's Annual Meeting outlining initial six-month results from the study, which was conducted by Dr. Paul O'Connor at St. Michael's Hospital in Toronto. Twenty-nine patients were treated monthly with 25 mg/m2 or 50 mg/m2 of paclitaxel and both treatment groups demonstrated favorable trends in disability scores. In the high-dose group, patients showed a significant improvement in all tests undertaken, including functional testing, quality of life measures and changes in the amount of brain tissue scarring demonstrated by magnetic resonance imaging (MRI). Based on these results, and for compassionate reasons, the investigators and Angiotech elected to treat 22 of the patients at 50 mg/m2 for an additional six-month period.
Throughout the entire course of the study, the primary objective was met, as the drug was demonstrated to be safe and well tolerated in this patient population (no drug-related serious adverse events were reported). In addition, patients continued to show favorable trends in both clinical disability and MRI outcome measures during the extension period. Clinical disability, measured monthly using the Expanded Disability Status Scale (EDSS), showed that more than 95 percent of the patients (21 out of 22) remained stable or improved after twelve treatments administered over a 16-month time span. Fifteen patients demonstrated disease stabilization, six showed confirmed disease improvement and only one patient exhibited confirmed disease progression. The average EDSS score among all patients improved by 0.205 over the 16-month period.
Before and after each six-month treatment phase (at Baseline, Month 6, Month 10 and Month 16) patients were assessed by MRI. Preliminary results indicate that patients treated at 50 mg/m2 for the entire study showed favorable trends in gadolinium enhancing lesions, burden of disease, validated lesion number, black hole number and black hole volume. The above MRI measures will be further evaluated in the Company's recently initiated 189-patient, Phase II clinical study, which utilizes MRI parameters as the primary outcome.
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 often have a fatal outcome, it disables patients by disturbing vision, strength, balance and sensation, as well as causing fatigue and cognitive problems. Approximately 40 percent of all MS patients have secondary progressive multiple sclerosis. It is the most chronic form of MS, which follows the relapsing-remitting phase of the disease. MS is one of the most disabling diseases of the nervous system in young people, affecting as many as 350,000 persons in the U.S. Historically, 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 pharmaceutical company dedicated
to the development of medical device coatings and treatments for chronic
inflammatory diseases through reformulation of the anticancer drug, paclitaxel.
Three pharmaceutical therapies are in clinical development: systemic paclitaxel
for secondary progressive multiple sclerosis (Phase II), systemic paclitaxel
for rheumatoid arthritis (Phase I) and topical paclitaxel for psoriasis
(Phase I and Phase I/II). 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.
Related Links: paclitaxel and Angiotech Pharmaceuticals, Inc.