Repligen Corp. said that its imaging agent RG1068 met its goals in a late stage clinical trial, as it allowed radiologists to accurately scan the pancreas of their patients without producing many more false positives.
The results, disclosed Monday, come from a new analysis of the trial. Repligen originally said RG1068 did not meet its main goal in the study, but the company later said that analysis was flawed. Regulators in the U.S. and Europe agreed and allowed the company to have a different contract research organization and different radiologists review the scans.
RG1068 is designed to improve the accuracy of MRIs in patients with pancreatic disease. It works by stimulating the pancreas, which secretes fluid into the pancreatic ducts. The ducts fill with water, and abnormalities in the pancreas become easier to see on an MRI. The study compared the accuracy of MRIs of patients who took a dose of RG1068 to patients who did not take any imaging agents. Repligen said all three radiologists in the study reported greater sensitivity in finding abnormalities and small decreases in specificity.
Specificity is a measurement of how many patients were correctly identified as not having pancreatic disease. As a test becomes more sensitive, it is able to detect more abnormalities and potential illnesses, but incorrect positive readings become more likely.
Scans of 258 patients were used in the study, and their results were confirmed with an endoscopy. Repligen said no serious side effects or unscheduled hospitalizations were associated with RG1068. The drug will receive an expedited review by Food and Drug Administration regulators, and it was granted orphan drug incentives for use in conditions like pancreatitis.
Repligen reported initial results from the study in December 2009.