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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

ANN ARBOR, Mich., March 14, 2012 /PRNewswire/ -- Synthetic Biologics, Inc.  (NYSE Amex: SYN), a developer of synthetic DNA-based therapeutics and innovative disease-modifying medicines for serious illnesses, announced today that patient enrollment has been completed in a Phase II clinical trial evaluating the efficacy and safety of Synthetic Biologics' proprietary oral formulation of estriol (Trimesta™) for the treatment of relapsing-remitting multiple sclerosis (MS). With over $8 million in external grant funding awarded to date, this Trimesta clinical trial should be fully funded to its completion.

"The completion of patient enrollment into the Phase II Trimesta trial represents another important milestone for oral estriol and brings us one step closer to offering a new oral treatment option to patients with relapsing-remitting MS," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "As an oral therapy with a promising clinical profile, Trimesta is expected to be extremely well positioned to provide an important treatment option for this debilitating disease."

The randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial of Trimesta (oral estriol) for relapsing-remitting MS in women initially enrolled a total of 164 patients. At 15 sites in the United States, clinical investigators have been administering either oral Trimesta or matching placebo in addition to glatiramer acetate (Copaxone®), an FDA-approved therapy for MS, to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS. MS patients are being dosed and monitored for two years. The primary outcome measure for the study is the rate of relapse between the placebo and treated groups at two years, an accepted FDA-approvable endpoint in MS.  Additional information regarding the relapsing-remitting MS clinical trial
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