Estriol gets bigger trial

If it's on your mind and it has to do with multiple sclerosis in any way, post it here.

Estriol gets bigger trial

Postby TwistedHelix » Fri Mar 23, 2007 8:57 am

[ Back to EurekAlert! ] Public release date: 22-Mar-2007
[ Print Article | E-mail Article | Close Window ]

Contact: Mark Wheeler
mwheeler@mednet.ucla.edu
310-794-2265
University of California - Los Angeles
Could estriol be the elixir for MS?
UCLA researcher's promising pilot study moves to widespread clinical trial to thwart multiple sclerosis

It has long been common knowledge that pregnant women with multiple sclerosis (MS) experience a sharp drop in the disease's symptoms during the course of their pregnancy.

Some years back, Dr. Rhonda Voskuhl, director of UCLA's Multiple Sclerosis Program, and her colleagues discovered the cause. They found that a female sex hormone called estriol, which is produced during pregnancy, was responsible for the suppression. Four years ago, Voskuhl followed that discovery with a pilot study in which 10 non-pregnant women with MS were given estriol, yielding what she described as "pretty remarkable" results — an 80 percent drop in inflammatory lesions in the brain, a hallmark of the disease.

This month, Voskuhl begins a much larger trial of estriol, one that will involve 150 patients at multiple locations over the next two years. The prospects, she said, are exciting.

Multiple sclerosis is an autoimmune disease of the central nervous system that attacks the tissue surrounding the brain's nerve fibers. This tissue, called myelin, can be thought of as the insulation wrapped around an electrical wire. When the myelin is damaged, the nerve's ability to send signals to and from the brain is interfered with, resulting in symptoms common to MS, including problems with balance, memory, vision loss and more.

Currently, anti-inflammatory drugs used to treat MS lessen the symptoms and slow the progression of the disease. But they must be given by injection daily, weekly or monthly — depending on the drug — and are expensive, costing between $12,000 to $24,000 a year.

Estriol is a hormone produced by the placenta that is virtually undetectable until pregnancy, when it progressively increases. It is thought that its role is to suppress a woman's immune system when she is pregnant, so that the fetus will not be seen by the body as a foreign "invader."

"The beauty of estriol is that it can be given as a pill, not a shot, and also that it's not a new drug; it has decades of safety behind it," said Voskuhl, who holds the Jack H. Skirball Chair for Multiple Sclerosis in the UCLA Department of Neurology. For years estriol has been in widespread use in Europe and Asia as hormone replacement therapy for women with menopausal symptoms. The fact that the pill already exists, she said, should dramatically reduce the cost of treatment.

Most important of all, though, is that the drug potentially provides a one-two punch against MS, both reducing the ability of immune cells to attack the brain, as well as making the brain more resistant to damage if any immune cells do make it through.

"It's a two-pronged approach an anti-inflammatory prong to reduce the attacks, but also a neuroprotective prong to make the brain suffer less damage in case of an attack," said Voskuhl.

In all, seven institutions from around the nation will be involved in the two-year study. The investigators plan to recruit 150 women who have not previously been treated for MS. They will be given either estriol along with Copaxone, an MS drug currently in use, or a placebo along with Copaxone. "That way, no one will receive less than the standard of care," Voskuhl said. The team will measure relapse rates over the course of the trial.

###

Initial funding of $667,000 for the trial is being provided by the Southern California Chapter of the National Multiple Sclerosis Society. The total cost of the trial is expected to be $4.7 million.

For more information about the trial, please contact the UCLA MS program at (310) 825-7313.

[ Back to EurekAlert! ] [ Print Article | E-mail Article | Close Window ]
User avatar
TwistedHelix
Family Elder
 
Posts: 599
Joined: Fri Mar 25, 2005 4:00 pm
Location: Northamptonshire, England.

Advertisement

Postby gwa » Fri Mar 23, 2007 10:28 am

Since pregnant women aren't taking Copaxone, I don't understand why the trial will include Copaxone.

If one of the main purposes of Estriol is to get away from shots, this trial makes no sense to me.

They should at least give 30% of the women only Estriol to test the efficacy of this drug as a stand alone treatment.

I emailed the address given and asked why they are combining it with Copaxone. Hopefully someone will answer me.

gwa
User avatar
gwa
Family Elder
 
Posts: 846
Joined: Thu Dec 01, 2005 4:00 pm

Postby gwa » Fri Mar 23, 2007 1:46 pm

I got a reply from the man listed on the story.

He is not a scientist and knows nothing about Copaxone, but believes that the researchers don't want to have anyone diagnosed with MS untreated for two years.

Thus, they have chosen Copaxone as the drug of choice to be used in conjunction with Estriol.

gwa
User avatar
gwa
Family Elder
 
Posts: 846
Joined: Thu Dec 01, 2005 4:00 pm

Postby TwistedHelix » Sat Mar 24, 2007 7:19 am

Thanks for that, gwa, I was all set to get really suspicious that this trial was being funded by the manufacturers of Copaxone.

It does seem slightly odd, though, to trial oestriol, (my computer insists on British spelling), as part of a combination which can only conclude that the two substances work together or against each other.

I remember reading about a Russian treatment for MS which sounded extremely dubious at the time, but which might actually have involved oestriol. The procedure was to cut open a small flap of skin below the navel and insert a piece of placenta. Only one layer of the placenta was used, which is, "immunologically privileged", (ie it doesn't provoke rejection by the immune system), and it was touted as "a miracle cure". Maybe there was something in it, after all,

Dom.
User avatar
TwistedHelix
Family Elder
 
Posts: 599
Joined: Fri Mar 25, 2005 4:00 pm
Location: Northamptonshire, England.

Postby gwa » Sat Mar 24, 2007 10:05 am

Dom,

Since this is a two year (probably expensive) trial, my guess is also that Teva Pharmaceuticals may be putting up money and requiring Copaxone to be part of the study.

This is only my guess and I could be dead wrong. For me, it is the only thing that makes sense.

gwa
User avatar
gwa
Family Elder
 
Posts: 846
Joined: Thu Dec 01, 2005 4:00 pm

Postby Lyon » Sat Mar 24, 2007 10:22 am

Of course they're not always right but it seems that going into these trials the researchers at least think they have a grasp on the efficacy of what they are testing.

Maybe the situation isn't really quite so heartless but with a treatment in which researchers have high hopes will prove effective, I can see them consoling themselves that putting people on placebo is a necessary evil in order to prove the merits of a treatment which will prove beneficial to society in the long run.

In a treatment which the researchers don't have high hopes for....maybe their conscience has a tendency to want the people to be on some kind of "proven" treatment during that time?

I can't say but something along those lines is where my mind went with it.

Bob
Lyon
Family Elder
 
Posts: 6063
Joined: Wed May 03, 2006 3:00 pm


Return to General Discussion

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users

cron