Annikki
Senior Member
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Research has found that autoimmune disease symptoms decrease in the third trimester of pregnancy. The reason for this is a hormone associated with protecting the fetus from the mother's immune system called estriol. The hormone is now being used to control multiple sclerosis symptoms. Here's some of the press release:
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http://m.prnewswire.com/news-releas...tiple-sclerosis-clinical-trial-130110268.html"ANN ARBOR, Mich., Sept. 19, 2011 /PRNewswire/ --Adeona Pharmaceuticals, Inc. (AMEX: AEN), a developer of innovative medicines for serious central nervous system diseases, announced today that the 150th patient has been enrolled in the randomized, double-blind, placebo-controlled, multi-center clinical trial of its Trimesta (oral estriol) drug candidate for relapsing-remitting multiple sclerosis (MS) in women, per the original protocol.
We are excited to announce the enrollment of the 150th MS patient in this clinical trial, achieving our original targeted goal for enrollment. I am also very pleased that we have funds available to continue enrolling additional patients in this landmark MS trial," said Dr. Voskuhl. "Of the 400,000 people in the U.S. afflicted with MS, approximately 85% are initially diagnosed with relapsing-remitting MS, which is characterized by relapses, or attacks of declining neurologic function, followed by periods of remission. As we continue to dose and monitor each MS patient enrolled in the trial over a two year period, we would expect to demonstrate a statistically significant reduction in the rate of relapses in the patients treated with oral Trimesta."
"Completing enrollment in the Trimesta MS clinical trial as originally prescribed in the protocol is a significant milestone for Adeona and for MS patients, as it brings us one step closer to a potential treatment for women suffering from this devastating disease," stated James S. Kuo, M.D., M.B.A., Adeona's Chairman and CEO. "Once all of the patients have been enrolled and dosed for two years, we look forward to announcing Dr. Voskuhl's top-line results, and if positive, we would expect to seek FDA guidance on filing a New Drug Application."
Trimesta (oral estriol) is Adeona's proprietary drug candidate for the treatment of relapsing-remitting MS in women. Estriol has been approved and marketed for over 40 years throughout Europe and Asia for the treatment of post-menopausal hot flashes. It has never been approved by the FDA for any indication in the United States.
It has been scientifically documented that pregnant women with certain autoimmune diseases experience a spontaneous reduction of disease symptoms during pregnancy, particularly in the third trimester. The PRIMS (Pregnancy In Multiple Sclerosis) study, a landmark clinical study published in the New England Journal of Medicine followed 254 women with MS during 269 pregnancies, and for up to one year after delivery. The PRIMS study demonstrated that relapse rates were significantly reduced by 71 percent (p < 0.001) through the third trimester of pregnancy compared to pre-pregnancy-rates, and that relapse rates increased by 120 percent (p < 0.001) during the first three months after birth (post-partum) before returning to pre-pregnancy rates.
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