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news.Repligen has started a Phase III clinical trial to evaluate the use of RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging.
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This Phase III study is a multi-center, baseline-controlled, single dose study in which approximately 250 patients will receive an unenhanced magnetic resonance imaging (MRI) followed by a secretin-enhanced MRI of the pancreas. This study is designed to assess the sensitivity and specificity of secretin- enhanced MRI to improve the ability to detect pancreatic duct abnormalities relative to MRI alone. This study is being conducted at approximately 30 clinical sites within the US and Canada.
RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion. The use of secretin in combination with a non- invasive procedure such as MRI is expected to improve the detection of abnormalities and increase the diagnostic quality of the MRI image of the pancreas.
Walter Herlihy, president and CEO of Repligen, said: “Based on discussions with the FDA, we believe a single positive Phase III clinical trial of similar design to our Phase II study will be sufficient for an NDA filing.”