Friday, Sep. 19, 2008
COPAXONE(R) Demonstrated Protective Effect in Patients with Clinically Isolated Syndrome Suggestive of Multiple Sclerosis
PreCISe Data Presented at World Congress on Treatment and Research in Multiple Sclerosis
JERUSALEM — New data from PreCISe, in clinically isolated syndrome patients, have demonstrated that COPAXONE(R) (glatiramer acetate injection) significantly improved neuro-axonal integrity in patients presenting with a first clinical event suggestive of multiple sclerosis (MS) versus patients who received placebo (p=0.03), as measured by proton magnetic resonance spectroscopy (MRS). This effect was maintained over two years of treatment.
The data represent the first evidence of neuro-axonal protection by a disease modifying therapy in patients presenting with a first clinical event suggestive of MS.
Data were derived from an ancillary study from the Phase III, randomized, placebo-controlled PreCISe trial, which demonstrated that patients treated with COPAXONE(R) (n=243) had a 45 percent reduction in the risk of developing clinically definite multiple sclerosis (CDMS) compared to those on the placebo (n=238).
"These newly announced data, so far shown in RRMS patients treated with COPAXONE(R), provide more evidence that treatment may control the neuronal damage associated with MS disease pathology," said Douglas Arnold, M.D., Professor of Neurology, McGill University and the primary investigator of this ancillary study. "The PreCISe trial demonstrated a significant benefit of COPAXONE(R) on both clinical and MRI disease activity, along with further reinforcing the excellent safety profile."
The data were presented along with two other presentations from the PreCISe study at the World Congress on Treatment and Research in Multiple Sclerosis, in Montreal, Canada. Additional data derived from the PreCISe study demonstrated that COPAXONE(R) significantly delayed time to conversion to CDMS and reduced magnetic resonance imaging (MRI) disease activity. The effect was robust among the PreCISe study population (n=481), as a whole and also in subgroups of patients (segmented by gender, age, type of unifocal manifestation as well as steroid treatment for the initial attack, and MRI findings at study baseline). Based on these data, applications for marketing authorization for the extension of its indication to include the treatment of patients with a first clinical event suggestive of MS were submitted in Europe and in the U.S. and are currently under review.
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