CAUTION: ADVANCE FOR RELEASE AT 04:01 A.M. EST MONDAY, MARCH 1/
ADVANCE/HOUSTON, March 1 /PRNewswire/ -- The largest drug trial for primary
progressive multiple sclerosis launches Monday, March 1, at The University of
Texas -- Houston Health Science Center. The nationwide Promise study will
investigate whether COPAXONE(R) (glatiramer acetate for injection) is
effective in slowing the progression of primary progressive MS.
Primary progressive MS is one of the rarest types of multiple sclerosis,
affecting more than 50,000 people nationwide. However, it is the most severe
form of the disease.
"Primary progressive multiple sclerosis is characterized by a steady worsening
of the disease from the beginning. These patients currently face a poor
prognosis because there are no therapies available. A trial of this magnitude
could offer hope," said Jerry Wolinsky, M.D., director of the Multiple
Sclerosis Research Group at The University of Texas -- Houston Health Science
Center and principal investigator for the trial.
The three-year study will encompass 54 universities and medical centers in the
United States and Canada, and seeks to recruit 900 participants.
"A trial of this magnitude has never before been attempted on primary
progressive multiple sclerosis. A study group this large will give us a good
measure of how COPAXONE(R) (glatiramer acetate for injection) affects the
progression of disability in this form of multiple sclerosis," said Dr.
Wolinsky.
COPAXONE(R) currently is labeled for use in relapsing-remitting multiple
sclerosis. It was approved by the FDA in December 1996, and made commercially
available in April 1997. Early in the drug's development, researchers tested
COPAXONE(R) on a small group of people with primary progressive MS. The
results were encouraging, leading researchers to return to study COPAXONE(R)'s
effect on this patient group.
"We know from almost six years of research that COPAXONE(R) delivers sustained
efficacy in reducing relapses for patients with relapsing-remitting multiple
sclerosis, but a positive outcome for this patient group doesn't necessarily
mean the results will be as good for primary progressive multiple sclerosis,"
Dr. Wolinsky said.
"The fact that such a large study is investigating a drug therapy could be
good news for people with PPMS, but it is just the beginning."
People with a confirmed diagnosis of primary progressive MS who are interested
in participating in this trial should call toll free 877-758-7766 for more
information. As with any clinical trial, there are some risks. People
interested should call for more information about the trial, its requirements
and its risks.
Note: COPAXONE(R) is not labeled for use in primary progressive multiple
sclerosis, but it is labeled for relapsing-remitting multiple sclerosis. For
a copy of the prescribing information for COPAXONE(R) as labeled for
relapsing-remitting multiple sclerosis, please call 816-512-2349.
SOURCE University of Texas-Houston Health Science Center
CO: University of Texas-Houston Health Science Center
ST: Texas
IN: MTC
SU: PDT