Action Pharma in new phase II clinical trial on organ protection in patients undergoing cardiac surgery
Action Pharma has initiated a new clinical phase II trial for it's leading development candidate AP214, investigating the effect of AP214 on organ protection in patients undergoing cardiac surgery, who are at increased risk of kidney injury. The clinical trial has been launched in Denmark at "Rigshospitalet".
"The phase II clinical trial is a major milestone for Action Pharma and we are very impressed with the efficient and professional team at Rigshospitalet headed by chief consultant, professor Daniel Steinbrüchel as principal investigator", says Søren Nielsen, MD, DMSci, CEO of Action Pharma "Many patients in the USA and Europe undergo major thoracic surgery every year, and approximately 10-20% of these patients experience various degrees of kidney injury which again is associated with increased mortality, co-morbidity and prolonged hospitalization. Thus, in this indication there is a major unmet medical need."
The clinical trial investigating AP214 in cardiac surgery is conducted at Rigshospitalet, Department of Cardiac and Thoracic Surgery is a randomized, double-blind placebo-controlled dose-finding phase II trial in patients undergoing cardiac surgery. A total of 42 patients will be enrolled in the trial. Dosing of the first patient was initiated in June 2009 and dosing of the first cohort was completed in August 2009.
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