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Synthetic Biologics Announces Completion of Enrollment in 164 Patient Clinical Trial of Oral Trimesta™ for Multiple Sclerosis
Date:3/14/2012

is available at http://www.clinicaltrials.gov/ct2/show/NCT00451204.

Current sales of injectable disease-modifying therapies for MS are estimated at $8.9 billion annually.  According to various reports, sales of oral disease-modifying therapies for MS, of which Trimesta™ if and when approved would be in such class, are anticipated to exceed $5 billion annually by 2017.

"We are pleased to complete the enrollment of a total of 164 patients in this landmark MS trial," said Rhonda Voskuhl, M.D., Director, University of California, Los Angeles (UCLA) Multiple Sclerosis Program, UCLA Department of Neurology, and lead Principal Investigator of the trial. "In the United States alone, over 200 people per week are diagnosed with MS, and approximately 70% of them are women. Typically, relapsing-remitting MS is distinguished from the other forms of MS by the relapses, or attacks of declining neurologic function, followed by periods of remission. With this trial evaluating oral estriol (Trimesta), we would expect to demonstrate a reduction in the rate of relapses in these MS patients."

About Trimesta (oral estriol)

Trimesta is Synthetic Biologics' 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 s
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SOURCE Synthetic Biologics, Inc.
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