Contrast agent developer Epix Medical of Cambridge, MA, said that its investigational magnetic resonance angiography (MRA) agent MS-325 met all primary endpoints in a phase III trial of patients with suspected vascular disease in the renal and pedal arteries.
The trials examined 145 patients with suspected renal vascular disease and 96 patients with suspected pedal vascular disease.
Epix presented the results Thursday at the International Society for Magnetic Resonance in Medicine (ISMRM) conference in Toronto.
The company said the results, combined with results of the previous phase III trial and additional studies, provide a strong foundation to file for approval with the Food and Drug Administration later this year. In all, four phase III trials were conducted in 83 clinical sites on four continents, and involved 782 patients, Epix said.
MS-325 is a blood-pool contrast agent that binds to serum albumin, and brightens the blood for an extended period. Epix and its partner Schering of Berlin are developing the product to provide a minimally invasive alternative to x-ray angiography through enhanced MRA.
By AuntMinnie.com staff writersJuly 11, 2003
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