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News

FDA fast tracks synthetic human secretin for pancreatic imaging

Repligen : 17 April, 2008  (New Product)
The US Food and Drug Administration (FDA) has granted Fast Track designation to the development programme for Repligen’s RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI).
Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. Once a drug receives Fast Track designation, frequent communication between the FDA and the sponsor is encouraged throughout the development and review process.

In addition, many drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review, under which the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.

'We are very pleased that the FDA has recognised the urgent need for a safe procedure to assess pancreatic abnormalities,' stated Walter C Herlihy, president and chief executive officer of Repligen. 'We expect to complete patient enrollment in our Phase 3 clinical trial this year and, if successful, file an NDA in 2009.'

Repligen is currently conducting a Phase 3 clinical trial to evaluate the use of RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by Magnetic resonance imaging (MRI). The Phase 3 study is a multi-centre, baseline-controlled, single dose study in which approximately 250 patients will receive an unenhanced MRI followed by a secretin-enhanced MRI of the pancreas.

The study is designed to assess the sensitivity and specificity of secretin-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 USA and Canada.

Repligen previously conducted a multi-centre, 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 percent 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 visualised 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 USA each year that could benefit from enhancement with secretin.
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