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

pancreas in the U.S. each year that could benefit from the use of secretin."

Secretin is 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 to improve the detection and delineation of normal and abnormal structures of the pancreas and to quantify pancreatic fluid production, harnesses the natural biologic properties of the hormone to increase the diagnostic quality of the MRI image. The use of MRI is attractive for patient care as it can obviate the need for more risky invasive procedures.

The use of secretin in abdominal imaging may have application beyond improvements in detection of structural abnormalities. We are conducting several pilot studies to evaluate the use of secretin with MRI to assess among other things, the function of the pancreas. This study is based on the clinical observation that patients with pancreatic diseases have a reduced fluid production response to secretin stimulation and will be designed to confirm and quantify this observation. The Office of Orphan Products Development of the FDA granted Repligen orphan drug designation for RG1068, synthetic human secretin, for use with MRI of the pancreas. Orphan drug designation qualifies Repligen for seven years of exclusive marketing rights in the United States if the company is first to receive marketing approval for RG1068 for MRI imaging of the pancreas.

About Repligen Corporation

Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous sy
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