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news.Repligen has announced that the FDA has granted fast track designation to the development program for RG1068, a synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging.
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Repligen is currently conducting a Phase III clinical trial to assess the sensitivity and specificity of secretin-enhanced magnetic resonance imaging (MRI) to improve the ability to detect pancreatic duct abnormalities relative to MRI alone.
The Phase III study is a multi-center, baseline-controlled, single dose study in which approximately 250 patients will receive an unenhanced MRI followed by a secretin-enhanced MRI of the pancreas. The study is being conducted at approximately 30 clinical sites within the US and Canada.
Walter Herlihy, president and CEO of Repligen, said: “We expect to complete patient enrollment in our Phase III clinical trial this year and, if successful, file an NDA in 2009.”