Synthetic Biologics Issues UCLA Report of Prelim. Positive Topline Efficacy, Safety Results from Phase II Study of Trimesta

Synthetic Biologics, Inc. (NYSE: SYN), a developer of novel anti-infective biologic and drug candidatestargeting specific pathogens that cause serious infections and diseases,reported today that the University of California, Los Angeles (UCLA) School ofMedicine announced preliminary, positive topline data from the Phase IIclinical trial evaluating Trimesta™ (oral estriol), the Company's oral,once-daily treatment for relapsing-remitting multiple sclerosis (RRMS) inwomen. The Phase II study, initiated and led by Rhonda Voskuhl, M.D.,Professor, Department of Neurology, Jack H. Skirball Chair in MultipleSclerosis Research and Director, Multiple Sclerosis Program at UCLA DavidGeffen School of Medicine, demonstrated that Trimesta given with first-lineRRMS therapy Copaxone® (glatiramer acetate injection) resulted in reducedannualized relapse rate and improved cognitive function at 12 months oftreatment as compared to placebo plus Copaxone. Dr. Voskuhl presented thePhase II topline data today at the 66^th Annual Meeting of the AmericanAcademy of Neurology in Philadelphia as part of the Emerging Science Program.Synthetic Biologics, Inc. Logo.Dr. Voskuhl commented, "Pregnancy is known to be a period of relativeprotection from MS relapses, and the therapeutic effects of pregnancyhormones, including estriol, include both anti-inflammatory andneuroprotective mechanisms as evidenced in animal models of MS. We areencouraged by the topline results from this first randomizedplacebo-controlled trial evaluating oral estriol due to the positive impact ofadjunctive therapy with estriol on the patients in this study. We look forwardto continued clinical evaluation of estriol, which we believe has thepotential to slow disease progression and improve quality of life for womenwith RRMS."The Phase II, double-blinded, placebo-controlled trial randomized 158 womenwith relapsing-remitting MS at 16 sites across the U.S. Among topline results,women receiving Trimesta plus Copaxone demonstrated a statisticallysignificant 47 percent decrease in annualized MS relapse rate in the first 12months of treatment as compared to women receiving placebo plus Copaxone. Inaddition, a significant improvement in cognitive function was observed at 12months as measured by Paced Auditory Serial Addition Test (PASAT) scores.After 24 months of treatment, the reduction in relapse rate persisted in favorof the Trimesta plus Copaxone treatment group compared to the Copaxone plusplacebo group (32 percent). Both treatment groups exhibited improvement inmeasures of cognitive function at 24 months. Treatment was safe and welltolerated with no evidence of adverse effects on breast or uterus."The topline data presented today are encouraging for women with MS, includingthe approximately 260,000 women with MS in the United States. We believeadjunctive therapy with Trimesta has the potential to improve therapeuticoutcomes for women currently taking first-line RRMS treatments. Trimesta'sdifferentiated mechanism of action, combined with the convenience ofonce-daily oral dosing, may potentially make it an ideal added therapy toaddress this underserved $14.1 billion worldwide market," stated JeffreyRiley, Chief Executive Officer of Synthetic Biologics. "As Synthetic Biologicsdetermines next steps for Trimesta, including potential plans for a Phase IIIclinical program, we look forward to feedback from the neurology community andfrom potential partners regarding the encouraging topline data presented byDr. Voskuhl."The investigator-initiated, Phase II, two-year, multi-center, randomized,double-blinded, placebo-controlled (1:1) study evaluated Trimesta as an oral,once-daily dose of 8 mg per day plus Copaxone in women with RRMS, aged 18-50years. Dr. Voskuhl's work is supported by grants exceeding $8 million, whichwere awarded primarily by the National Multiple Sclerosis Society (NMSS) inpartnership with the NMSS's Southern California chapter, and the NationalInstitutes of Health (NIH).