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

with the endoscopy procedures. The most commonly reported SAE following endoscopy was acute pancreatitis requiring hospitalization.

"Although this study did not achieve the pre-specified statistical outcome for the primary endpoint, it provides further evidence of the benefits of RG1068 in MRI imaging of the pancreas," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "Further development plans for RG1068 will be determined following discussion of these results with the FDA next quarter."

This was a multi-center, baseline controlled, single dose study in which 258 patients with a history of pancreatitis at 23 clinical sites within the U.S. and Canada received an MRI of the pancreas with and without RG1068, and independently an endoscopic procedure called ERCP. The MRI imaging results were randomized and independently evaluated by three radiologists blinded to the details of the MRI procedures for evaluation of pancreatic duct abnormalities, image quality, number of duct segments visualized and confidence in diagnosis. The use of MRI is attractive for patient care as it can obviate the need for more risky invasive procedures such as ERCP.

RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion. Secretin has been used for many years by gastroenterologists in conjunction with ERCP, an invasive procedure to evaluate and treat diseases of the pancreas and gallbladder. There are risks associated with the use of ERCP, which have generated interest in the development of safer non-invasive tests to diagnose gastrointestinal disorders. The use of RG1068 in combination with a non-invasive procedure such as MRI can improve the detection of abnormalities and increase the diagnostic quality of the MRI image of the pancreas. The FDA has granted RG1068 Orphan Drug status and Fast Track Designation, a process designed to facilitate the deve
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SOURCE Repligen Corporation
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