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news.Innocoll has commenced dosing for the second of two Phase III clinical trials sponsored by its wholly owned subsidiary, Innocoll Technologies to investigate CollaRx Gentamicin Surgical Implant for the prevention of surgical site infections.
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According to advice from the FDA, Innocoll will conduct two multi-centered Phase III clinical trials in the US to support the planned new drug application (NDA). Innocoll has appointed Duke University’s Duke Clinical Research Institute (DCRI) as the study coordinating center for both trials. Approximately 50 sites will be recruited for the trial in patients undergoing cardiac surgery and 35 sites for the colorectal surgery trial.
Michael Myers, Innocoll’s president and CEO, said: “With the commencement of this second Phase III trial, our sights are now well and truly set on NDA filing once these trials are complete.”