A Manganese Alternative To Gadolinium for MRI Contrast
Project Abstract:
Gadolinium based contrast agents GBCAs are routinely administered to visualize vascular and tissue irregularities using MRI Unfortunately concerns over GBCA toxicity in patients suffering kidney disease have emerged over the last decade In 2007 the FDA labeled all GBCAs with a black box warning and current American College of Radiology guidelines advise against using GBCAs in patients suffering moderatetoadvanced chronic kidney disease CKD acute kidney injury or requiring dialysis GBCA sales dropped by 1 million vials 10 in the year following the FDA issued warnings This decrease reflects contrast withheld from patients suffering moderatetoadvanced CKD 8 of the US population No replacement technology has emerged and CKD patients are continuously denied contrast enhanced examinations We developed a nongadolinium containing contrast agent to be compatible with renally insufficient patients Our product operates analogously to the standard of care but with an improved toxicity and clearance profile The primary indication for our product will be MR angiography but it is amenable to any applications requiring GBCAs CKD patients provide an immediate market penetration point for our product but we also expect to compete with GBCAs in patients with healthy kidney function The goal of this BBIC DRIVE grant is to derisk our product for clinical development through the following milestones 1 demonstrate equivalence to GBCA in imaging myocardial viability in a mouse model 2 demonstrate equivalence to GBCA in MR angiography in a NHP model 3 quantify DMPK in rats and NHPs 4 evaluate acute and subacute dose toxicity in rats
