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Repligen Reports Phase 3 Clinical Trial Results of RG1068 in Pancreatic Imaging
Date:12/9/2009

WALTHAM, Mass., Dec. 9 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) reported today top-line results from a Phase 3 clinical trial to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with a history of pancreatitis. The study's co-primary endpoints were improvements in sensitivity of detection of structural abnormalities of the pancreatic ducts using RG1068 in combination with MRI compared to MRI alone with minimal loss in specificity (<7.5%). The study design used endoscopy as the standard for determination of structural abnormalities. The predetermined criteria for a successful study were achievement of a statistically significant improvement in sensitivity with minimal loss in specificity from two of the three central radiologists reading the MRI images. In this study, one radiologist achieved a statistically significant improvement in sensitivity with RG1068 (p<0.001) while a second radiologist showed a trend but did not achieve statistical significance (p=0.088). There was minimal loss in specificity for all radiologists. While it was not a pre-specified endpoint, pooled data from all three radiologists resulted in a statistically significant improvement in sensitivity with RG1068 (p=0.005) with minimal loss in specificity.

The RG1068-enhanced MRI images showed highly statistically significant improvements on other endpoints for all radiologists including improvements in image quality (p<0.001), ability to see all three segments of the pancreatic duct (p<0.001), and physician confidence in their ability to identify pancreatic duct abnormalities (p<0.001), when compared to MRI alone. There were no serious adverse events (SAEs) associated with the RG1068-MRI procedures compared to 55 SAEs associated
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