Tuesday, January 30, 2007

New Trial for MS Drug

The Press-Enterprise

People living with multiple sclerosis have to use injections to help control the disease. The method is the only anti-inflammatory treatment available.

But a new clinical trial, which is seeking participants, may help women with MS get rid of the needles.

Researchers hope an estrogen called estriol will help women with relapsing-remitting multiple sclerosis. It marks the first large-scale trial of a sex hormone to treat the disease, according to the National MS Society.

"Pregnancy makes a variety of autoimmune diseases get better," said Dr. Rhonda Voskuhl, who is heading the study at UCLA.

One of the diseases it helps is multiple sclerosis, a disease that attacks the central nervous system. In MS, the myelin sheath around nerves which helps conduct electrical impulse is lost in multiple areas and replaced with scar tissue.

Relapsing-remitting MS is the most common form of the disease, according to the national society. It involves bouts of acute downslides in neurological function, followed by partial or full recovery periods in which the disease no longer progresses.

Voskuhl and a team at UCLA, as well as six other universities around the country, will start enrollment at the end of February for a two-year clinical trial of estriol with about 130 nonpregnant women with MS.

The disease affects two to three times more women than men, according to the National MS Society.

About four years ago, Voskuhl did a small-scale study of estriol with 12 women who had MS.

"We saw an improvement in cognitive functions," she said.

The study also saw an 80 percent reduction in inflamed regions in the brain.

Voskuhl hopes the new estriol study will yield positive results of protecting the nerves and reducing lapses, and not just act to help inflammations.

Estriol is taken in pill form, which would ultimately be cheaper than current treatments. Voskuhl said injection treatments can cost a patient anywhere from $12,000 to $20,000 each year.

Leon LeBuffe, president of the Southern California chapter of the National MS Society, said that the cost and needles are two of the biggest objections patients have to current treatment.

Throughout the study, women will take a daily shot of the anti-inflammatory drug Copaxone as well as an estriol pill or a placebo.

"Nobody gets less than the standard of care," Voskuhl said.

The estriol trial is one of the prominent research projects going on for multiple sclerosis, and has a price tag of $4.7 million, according to the Southern California Chapter of the National MS Society.

The chapter has promised to raise the money for the study and has already made a "rescue" pledge of $667,000 to start the trial, said Marni Deckter, communications director for the chapter.

"For us, it's a huge task to raise this much money," LeBuffe said.

Enrollment for the study is slated to begin in late February at UCLA, Wayne State University in Detroit, Washington University in St. Louis, University of Chicago, University of Utah in Salt Lake City, Robert Wood Johnson Medical School in New Jersey and Ohio State University in Columbus.

Reach Vanessa Franko at 951-368-9575 or at vfranko@PE.com

Qualifications for participating in estriol study:

Women diagnosed with relapsing-remitting MS, ages 18-50

No previous treatment with Copaxone

No interferon treatment, unless newly diagnosed and treated for less than three months