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news.Cardiome Pharma has initiated subject dosing in a Phase I study of its cardiovascular treatment, a dose-ranging study that will measure the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug in 24 healthy subjects.
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GED-aPC is an engineered analog of recombinant human activated protein C with enhanced anti-inflammatory, anti-thrombotic and strong binding to endothelial protein C receptor properties, and has broad potential across multiple indications. Each subject will receive a 15-minute loading dose at the start of a 24-hour continuous intravenous infusion of GED-aPC. Results from this study are expected in the first half of 2008.
In April 2007, Cardiome acquired exclusive worldwide rights for GED-aPC for all indications. Cardiome intends to initially develop GED-aPC in cardiogenic shock, a life-threatening form of acute circulatory failure due to cardiac dysfunction, which is a leading cause of death for patients hospitalized following a heart attack.
Bob Rieder, chairman and CEO of Cardiome, said: “We believe strongly that GED-aPC has the potential to be effective in treating a variety of cardiovascular diseases, and intend to aggressively advance this exciting new drug candidate through a rigorous clinical program.”