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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.
News For SYN From The Last 14 Days
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November 24, 2014
09:23 EDTSYNOn The Fly: Pre-market Movers
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06:59 EDTSYNSynthetic Biologics to initiate clinical trials of SYN-004
Synthetic Biologics announced that its Investigational New Drug, or IND, application which was submitted to the FDA in October will be proceeding into clinical trials for the development of the Company's oral beta-lactamase enzyme SYN-004 for the prevention of Clostridium difficile, or C. difficile, infection, antibiotic-associated diarrhea, and secondary infections with healthcare-acquired, drug-resistant pathogens in patients receiving intravenous beta-lactam antibiotic therapy. Synthetic Biologics plans to begin Phase 1a and 1b clinical trials shortly, with topline data expected to be reported before year-end. Synthetic Biologics has met each milestone for its C. difficile program leading up to the IND submission to the agency. Clinical drug manufacturing of SYN-004 under cGMP guidelines to support Synthetic Biologics' planned Phase 1 and 2 clinical trials was completed on time to support the IND submission and clinical trial initiation. Most recently, the U.S. Patent and Trademark Office issued a Notice of Allowance for the first composition of matter patent application directly pertaining to SYN-004 in the U.S., which carries a patent term to at least 2031.
November 14, 2014
06:57 EDTSYNSynthetic Biologics reports Q3 EPS (8c), consensus (5c)
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