Repligen Reports Positive Phase 2 Clinical Trial Results of,Secretin for MRI Imaging of the Pancreas ( WALTHAM Mass. May 10 2007 /PRNewswi...)

Repligen Reports Positive Phase 2 Clinical Trial Results of,Secretin for MRI Imaging of the Pancreas

WALTHAM, Mass., May 10, 2007 /PRNewswire-FirstCall/ -- Repligen Corporation announced today positive results from a Phase 2 clinical trial to evaluate the use of RG1068, synthetic human secretin, as an agent to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). The study showed an improvement in sensitivity of detection of structural abnormalities of the pancreatic duct of approximately 20% with no loss in specificity, consistent with prior data and expectations. In addition, the study showed highly significant increases in the following three assessments: physician confidence in their ability to identify structural abnormalities, the number of pancreatic duct segments visualized and improvement in the overall quality of the MRI images. Detailed visual assessment of the pancreatic ducts and identification of structural abnormalities is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis.

This was a multi-center, baseline controlled, single dose study in which 80 patients with a history of pancreatitis received a secretin-enhanced MRI and an unenhanced MRI of the pancreas. All study operations and data analyses were conducted with protocols previously discussed with the U.S. Food and Drug Administration (FDA).

"We are pleased with the successful outcome of our first prospectively defined, blinded, multi-center clinical study to assess the use of secretin to aid in the detection of structural abnormalities of the pancreas," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. "These quantitative results confirm what has previously been reported by physicians, and establishes a sound basis for discussions with the FDA regarding a clinical plan to receive marketing approval for secretin for MRI imaging of the pancreas. We believe there may be more than 100,000 potential MRI images of the
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