EMBARGOED FOR MARCH 1, 1999
Contacts: Sandra Henry
University of Texas--Houston Health Science Center
713/500-3308
Holly Gibson
Fleishman-Hillard, Inc.
[email protected]
816/512-2349
PROMISE TRIAL LAUNCH MARKS LARGEST PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS DRUG TRIAL
HOUSTON, Texas (Mar. 1, 1999) -- 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 (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 (glatiramer acetate for injection) affects the progression of disability in this form of multiple sclerosis," said Dr. Wolinsky.
COPAXONE 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 on a small group of people with primary progressive MS. The results were encouraging, leading researchers to return to study COPAXONE's effect on this patient group.
"We know from almost six years of research that COPAXONE 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 1-877-758-7766 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.
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Note: COPAXONE 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 as labeled for relapsing-remitting multiple sclerosis, please call 816/512-2349.
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