Drug evaluation: PB-127, a novel contrast agent for the detection of myocardial perfusion.
Point Biomedical Corp is developing PB-127 (CardioSphere) as an ultrasound imaging agent for assessing myocardial perfusion in patients with coronary artery disease. In January 2006, the company submitted an NDA for the agent; this was accepted for review in February 2006, with a Prescription Drug User Fee Act review and action date of late October 2006. PB-127 is effective for intermittent harmonic power Doppler imaging and may be the first contrast agent to receive FDA approval for myocardial perfusion imaging.
Patrianakos
Alexandros P
AP
Cardiology Department, Heraklion University Hospital, PO Box 1352 Stavrakia, Heraklion, Crete 71409, Greece. patrianakos@edu.med.uoc.gr
Hamilos
Michael I
MI
D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D000818:Animals; D003287:Contrast Media / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D003324:Coronary Artery Disease / Q000175:diagnosis*; D004353:Drug Evaluation, Preclinical; D006801:Humans; D007262:Infusions, Intravenous; D010330:Patents as Topic; D011091:Polyesters / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D016032:Randomized Controlled Trials as Topic
D000418:Albumins; D003287:Contrast Media; C522044:PB-127 compound; D011091:Polyesters