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Synthetic Biologics Reports Second Quarter 2014 Financial Results and Operational Highlights
Date:8/14/2014

an Academy of Neurology annual meeting in April, lead investigator Rhonda Voskuhl, M.D. from the University of California, Los Angeles (UCLA) David Geffen School of Medicine, presented positive initial topline efficacy and safety results from the investigator-initiated Phase II trial evaluating adjunctive Trimesta in women with RRMS.
  • The study was a Phase II comparing Trimesta plus Copaxone® to Copaxone® alone as the active control arm in total of 158 women with RRMS.
  • Efficacy results far surpassed the investigator's expectations, meeting the pre-specified endpoint of the study protocol by demonstrating a statistically significant decrease in relapse rate after 12 months of therapy, for which the study was powered to achieve statistical significance, and a clinically meaningful reduction in relapse rate after 24 months of therapy, powered for trend as a pre-specified goal of the trial.
  • Trimesta in combination was also safe and well tolerated by women in the study.
  • The study also demonstrated statistically significant and clinically relevant improvement in cognitive scores at 12 months of therapy, which is of high importance for MS specialists and patients and is believed to be the result of Trimesta's unique neuroprotective effect.
  • Since the presentation of the initial topline results from the trial, significant additional analyses have been performed on various clinical outcome measures, as well as important parameters from ongoing analysis of MRI brain scans.
  • Dr. Voskuhl is scheduled to present some of the expanded data from this additional clinical outcome analyses, including more detailed results on cognitive and disability measures, at the ACTRIMS-ECTRIMS meeting in Boston on September 12, 2014.
  • A separate Phase II trial focused exclusively on cognition utilizing Trimesta with a variety of currently marketed MS drugs, including Copaxone®, Avonex®, Betaseron®, Extavia&#
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  • SOURCE Synthetic Biologics, Inc.
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