Dott. Carlo Sebastiano Tadeo
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
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
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