Tuesday, October 03, 2006

COPAXONE(R) Showed Sustained Benefit on Slowing Brain Tissue Damage in Multiple Sclerosis Patients

Oct 2 2006, 8:00 AM EST


Data presented last week at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Madrid, Spain, showed that COPAXONE(R) (glatiramer acetate injection) may slow the neurodegenerative tissue damage that is a key aspect of multiple sclerosis (MS) disease pathology. Results of the longest, prospective study of annual brain proton MRS imaging in relapsing-remitting multiple sclerosis (RRMS) patients suggested a beneficial effect of COPAXONE(R) treatment on cerebral axonal injury and recovery.

"These data reinforce the findings of previous studies showing that in addition to reducing relapses in RRMS patients over the long term, COPAXONE(R) may have the unique ability to slow or prevent neurodegenerative processes by reducing axonal injury and promoting axonal recovery within the central nervous system, and that this benefit is sustained over time," said Omar Khan, M.D., Wayne State University and lead investigator of the study.

In MS, measuring brain n-acetylaspartate (NAA) levels relative to creatine (Cr) (NAA/Cr ratios) via MRS is a method of assessing axonal injury caused by the disease. Decreased levels of brain NAA/Cr ratios are a marker of neuronal damage or degeneration and also correlate strongly to clinical disability; an increase in brain NAA/Cr ratios indicates a recovery of injured nerve cells or neurons in the brain. This study involved annual blinded MRS analyses of NAA/Cr of patients (n=22), over four years.

"Patients in this study who remained on COPAXONE(R) (glatiramer acetate injection) experienced an increase in mean NAA/Cr, pointing not only to the treatment's effect on slowing accumulation of brain tissue damage as measured by MRS, but to its effect on the recovery of damaged brain tissue," said Khan. "Measuring changes in NAA/Cr ratio throughout the course of the disease is of increasing interest to the MS research community because of data demonstrating its correlation with accumulated disability, pointing to the potential for MRS imaging to serve as a surrogate marker for both disease progression and therapeutic response in clinical practice."

About the Study

In this study, investigators performed annual conventional magnetic resonance imaging (MRI) as well as MRS measurements on treatment-naive RRMS patients (n=22), 18 of whom commenced treatment with COPAXONE(R) and four who remained untreated by choice. Over the four years of the study, blinded annual MRS analyses of NAA/Cr were carried out in a volume-of-interest (VOI) centered on the entire corpus callosum, which also allowed for the examination of the normal appearing white matter (NAWM) within the corpus callosum. At baseline, patients' (n=18) mean NAA/Cr ratios (+/-SD) for the entire VOI was 1.97 (+/- 0.24) and was 2.075 (+/- 0.30) in the NAWM. After four years of follow up, 15 of the 18 patients in the treated group were still receiving COPAXONE(R) and demonstrated an increase to a mean NAA/Cr of 2.21 (+/- 0.16) in the VOI and 2.27 (+/- 0.20) in the NAWM.