In previous development efforts in unrelated indications such as myocardial infarction and sickle cell disease, P-188 NF has been used in over 2,500 subjects, including pediatric subjects, at intravenous doses two orders of magnitude higher than proposed for Carmeseal-MD. While at these very high doses a safety signal was observed in much older individuals with myocardial infarction and compromised renal function (elevated serum creatinine), this signal was not observed in much younger patients with normal renal function, even at very high doses. This strongly indicates safe use of P-188 NF at the dose and the route proposed for Carmeseal-MD.
Dusty Brandom
High dose administration regimen in older patient with MI and compromised renal function that did show elevated serum creatinine levels in some subjects:
Collaborative Organization for RheothRx Evaluation (CORE). Effects of RheothRx on mortality, morbidity, left ventricular function and infarct size in patients with acute myocardial infarction. Circulation 1997; 96: 192-201.
High dose administration regimen that did not lead to elevated serum creatinine levels:
Adams-Graves P, Kedar A, Koshy M, Steinberg M, Veith R, Ward D, Crawford R, Edwards S, Busrack J, Emanuele M. RheothRx (poloxamer 188) injection for the acute painful episode of sickle cell disease: a pilot study. Blood 1997; 90:2041-2046.
Additional human studies at high intravenous doses:
