Schering AG, Germany announced the positive results of the final phase III studies for MS-325, an innovative blood pool agent for magnetic resonance imaging (MRI). The results of the two final trials were consistent with previously announced data from earlier phase III trials. They demonstrate statistically significant improvement in the accuracy for detecting renal and pedal vascular disease with MS-325-enhanced magnetic resonance angiography (MRA) compared to non-contrast MRA.
"We are pleased to see that the success of MS-325-enhanced MRA in all phase III trials supports the broad use of MS-325 in contrast enhanced MRA," said H. Michael Rook, Head of Diagnostics & Radiopharmaceuticals at Schering AG. "While providing an accurate visualization of the vascular system, MS-325 may enable radiologists to reduce the frequency of invasive X-ray angiography procedures, which involve the use of catheters."
MS-325 is developed by EPIX Medical and Schering AG and is the first blood pool MRI contrast agent for vascular imaging to have successfully finalized all phase III trials.
The NDA submission is planned for later this year.
The four phase III trials were conducted by EPIX in 86 clinical sites on 4 continents, and involved 782 patients. In all four trials, based on blinded interpretation of nearly 4000 blood vessels, MS-325 provided clinically significant improvement in diagnostic efficacy compared to non-contrast MRA. The overall accuracy of MS-325-enhanced MRA was similar to the individual X-ray reader's inter-reader accuracy.