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

Austin. Despite widespread vaccination, Pertussis rates in the United States continue to rise steadily, and according to the World Health Organization, B. pertussis infection causes an estimated 300,000 deaths worldwide each year, primarily among young, unvaccinated infants.

Pertussis Operational Highlights and Upcoming Milestones:

  • Positive preclinical data reported from two non-human primate studies, supporting the association of SYN-005 with favorable decreases in white blood cell counts within two days and achievement of nearly normal levels within one week of treatment with SYN-005.
  • Research was highlighted last month at a Gordon Research Conference on Microbial Toxins and Pathogenicity by Synthetic Biologics' academic collaborator at The University of Texas at Austin, Jennifer Maynard, Ph.D.
  • Dr. Maynard to present Synthetic Biologics' SYN-005 mAb combination for the treatment of Pertussis in an oral presentation at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on September 7th in Washington D.C.
  • Filing of IND and initiation of a Phase I clinical trial is expected during the first half of 2015. Topline data is expected within approximately 90 days of the start of the trial, after which a Phase II trial is planned, with topline results expected in the second half of 2015.
  • Orphan Drug designation request submitted for SYN-005 for the treatment of Pertussis.
  • Intend to initiate cGMP manufacturing of SYN-005 to support clinical studies.
  • Mr. Riley concluded, "We look forward to Dr. Voskuhl's presentation at the ACTRIMS-ECTRIMS meeting in September. Dr. Voskuhl is expected to provide details about the significant clinical outcome measures including relapse rate, disability, and cognition measures evaluated in this compelling Phase II trial. We believe the unique and differentiated anti-inflammatory, as well as neuroprote
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    SOURCE Synthetic Biologics, Inc.
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