Repligen Receives FDA Fast Track Designation for RG1068 for Pancreat...(in-enhanced MRI to improve the abilityto...),Health

Date:4/16/2008

in-enhanced MRI to improve the ability to detect pancreatic duct abnormalities relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis. The study is being conducted at approximately 30 clinical sites within the United States and Canada.

Repligen previously conducted a multi-center, baseline-controlled, single dose Phase 2 study in which 76 patients with a history of pancreatitis received an unenhanced pancreatic MRI followed by a RG1068-enhanced pancreatic MRI. The results of the study showed an improvement in sensitivity of detection of structural abnormalities of the pancreatic duct of approximately 20% with no loss in specificity. In addition, the study showed highly significant increases in 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.

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 combination with endoscopy, an invasive procedure to evaluate and treat diseases of the pancreas and gallbladder. There are risks associated with the use of endoscopy, which have generated interest in the development of safer non-invasive tests to diagnose gastrointestinal disorders. The use of secretin 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 use of MRI is attractive for patient care as it can obviate the need for more risky invasive procedures. There are approximately 150,000 pancreatic MRIs conducted in the U.S. each year that could benefit from enhancement with secretin.

About Repligen Corporation

Repligen Corporation is a bioph
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