Synthetic Biologics Announces Issuance of U.S. Patent patents for MS and other autoimmune diseases covering the uses of its oral estriol candidate, Trimesta

The patent includes claims to the use of the Company's drug candidate, Trimesta™ (oral estriol), in conjunction with a gestagen for the treatment of multiple sclerosis (MS) and other autoimmune diseases. The patent also includes a claim for the administration of Trimesta™, a gestagen and a third standard of care MS agent, such as glatiramer acetate injection (Copaxone®), interferon beta-1a (Avonex®, Rebif®), interferon beta-1b (Betaseron®, Extavia®) or sphingosine-1-phosphate receptor modulator (Gilenya®). Through its wholly owned subsidiary, Synthetic Biologics holds the exclusive license to the newly issued U.S. Patent 8,658,627, as well as U.S. Patents 8,372,826 and 6,936,599 and pending patents for MS and other autoimmune diseases covering the uses of its oral estriol candidate, Trimesta™.

In an on-going randomized, double-blind, placebo-controlled Phase II clinical trial for the treatment of women with relapsing-remitting MS, patients enrolled at 15 centers in the U.S. are administered either Trimesta™ in combination with Copaxone® and progesterone (a gestagen), or receive a placebo plus Copaxone®. Lead Principal Investigator of the clinical trial, Rhonda Voskuhl, M.D., Professor, Department of Neurology, Jack H. Skirball Chair in Multiple Sclerosis Research and Director, Multiple Sclerosis Program at the UCLA School of Medicine, is scheduled to present topline results from this trial at the American Academy of Neurology's (AAN) 66^th Annual Meeting in Philadelphia on April 29 & 30, 2014, as part of the AAN Emerging Science program. The clinical trial is supported by grants exceeding $8 million, awarded primarily by the National Multiple Sclerosis Society (NMSS) in partnership with the NMSS's Southern California chapter, and the National Institutes of Health.

"Claims in this new patent further expand Synthetic Biologics' intellectual property related to our oral estriol candidate, Trimesta^™, for the treatment of MS and other autoimmune diseases," stated Jeffrey Riley, Chief Executive Officer at Synthetic Biologics. "Our objective has been to continue to strengthen our intellectual property covering oral estriol and this patent is an achievement in that direction."
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Labels: Avonex, Betaseron, Copaxone, Extavia, For Doctors, Gilenya