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A Phase II
study is underway of a new injectable drug treatment for rheumatoid
arthritis sufferers.
Angiotech
Pharmaceuticals announced that it has begun a clinical study for
the use of Paxceed (Micellar paclitaxel for injection) in the
treatment of patients with rheumatoid arthritis.
The multi-center
study plans to enroll 50 rheumatoid arthritis patients between
the ages of 21 to 70 who have been unsuccessfully treated with
at least one disease-modifying anti-rheumatic drug (DMARD). The
purpose of the study is to determine the effectiveness of Paxceed
with respect to the signs and symptoms of rheumatoid arthritis.
"This
is an important study for us to determine what role Paxceed may
play in the treatment of patients with rheumatoid arthritis and
will help further elucidate the development path of this agent
in other autoimmune diseases," said Dr. William L. Hunter,
Chairman and CEO of Angiotech.
The primary
objective of the study is to assess the effectiveness of treatment
as measured by the proportion of patients who show a clinical
response of 20 percent improvement in criteria set forth by the
American College of Rheumatology.
To achieve
this result, patients must have at least 20 percent improvement
in tender and swollen joints and must improve by at least 20 percent
in three of five remaining measures which include the physician's
and patient's assessment of disease activity and the patient's
assessment of pain and physical function.
Other
sources: Angiotech Pharmaceuticals, Inc.
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