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April 23, 2014
07:30 EDTSYNSynthetic reports preclinical data to support clinical development of mAb
Synthetic Biologics announced positive preclinical research findings for SYN-005, the company's proprietary monoclonal antibody, or mAb, combination therapy for treating Pertussis. In the second pertussis study in particular, SYN-005 was associated with favorable decreases in white blood cell counts within two days and the achievement of nearly normal levels within one week. Based on positive non-human primate and murine model findings, Synthetic Biologics has filed an additional patent application around pertussis antibodies, intends to move into cGMP manufacturing of SYN-005, and intends to file an Investigational New Drug application to support a Phase I clinical trial expected to initiate during the first half of 2015. The Company also intends to request an Orphan Drug designation for SYN-005 for the treatment of Pertussis.
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May 4, 2015
06:59 EDTSYNSynthetic Biologics names Steven Shallcross as CFO
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April 27, 2015
07:00 EDTSYNSynthetic Biologics reports posters highlight preclinical data from SYN-005
Synthetic Biologics announced that preclinical data from its novel SYN-005 program for the treatment of Pertussis were presented in two posters at ECCMID 2015. The "Antibody Cocktail Effectively Treats Pertussis in a Baboon Disease Model" poster summarized preclinical efficacy data that support advancing Synthetic Biologics' novel monoclonal antibody combination, SYN-005, toward the clinic. The poster presented key data from both murine and non-human primate models with the following conclusions: In the murine model, prophylactic administration of hu1B7 and hu11E6, both individually and in combination, completely blocked the rise in white blood cell count that is characteristic of the disease and reduced bacterial colonization in the lungs. In the non-human primate model, therapeutic administration of SYN-005 reversed the rise in white blood cell count and accelerated the clearance of pertussis bacteria. The second poster, entitled "Spontaneous Identification of Bordetella bronchiseptica in a Baboon Colony: Potential Ramifications for Bordetella pertussis Modeling" presented data that further evaluated 16 non-human primates and provided new information important to the future use of this model.

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