Estriol trial

A board to discuss future MS therapies in early stage (Phase I or II) trials.

Estriol trial

Postby dignan » Tue Jan 30, 2007 7:10 am

Some news on a phase II trial of estriol in the US. I'm adding it to the pipeline, don't know why I hadn't done that already...



New Trial for MS Drug

January 29, 2007 - 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.

http://www.pe.com/lifestyles/stories/PE ... 216bd.html
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Postby connieb » Tue Jan 30, 2007 10:36 am

Another study in conjunction with Copaxone? What will this tell us about the efficacy of estriol?
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Postby mjs » Tue Jan 30, 2007 3:14 pm

connieb wrote:Another study in conjunction with Copaxone? What will this tell us about the efficacy of estriol?


Well given the limited efficacy of Copaxone, it will hopefully tell us quite a lot.

Although my partner is on an interferon now, she used Copaxone briefly (had to stop because of an allergic reaction a few weeks into it). Although the Copaxone injections were painful, I've always considered Copaxone the least 'toxic' (pharma) treatment available.

My partner is now on Betaseron - she seems to be tolerating the injections quite well, and it's comforting that the interferons are considered to have the best efficacy (outside Tysabri).
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Estriol Cost

Postby Shayk » Tue Jan 30, 2007 6:47 pm

Dignan wrote:
I'm adding it to the pipeline...

Thanks Dignan...there's no pharma to market it or issue press releases so I think estriol tends to be forgotten.
Estriol is taken in pill form, which would ultimately be cheaper than current treatments

As an FYI I pay US $24 per mo. for my prescription. It's a lot cheaper than the CRABS. 8)

And, assuming a positive trial outcome, I don't think it's totally out of the question that a form of estrogen (ER alpha) that is considered "non estrogenic" could someday be available for men. Check this early research.....

Estriol treatment ameliorates disease in males with EAE
Estrogen receptor (ER) expressions, ERalpha and ERbeta, were found to be equivalent in both genders....

These data support a potential role for estriol treatment for men in addition to women with MS

Sharon
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