Proteo Inc. and its wholly-owned subsidiary Proteo Biotech AG announced that the NHS Lothian's Edinburgh Heart Centre has completed final analysis of data from the investigator initiated Phase II clinical trial with Proteo's drug candidate Elafin for prevention of myocardial injury after coronary artery bypass surgery. The EMPIRE study was designed as a randomized, double-blinded and placebo-controlled study on 87 patients to investigate the therapeutic potential of a single preoperative Elafin dose on postoperative myocardial injury. This was measured by troponin I plasma concentration which is released by damaged heart muscle cells and its plasma concentration correlates with overall damage of the heart muscle.

It was assumed that this treatment would lower the troponin I release over 48 hours. Publication of the EMPIRE study results is planned in a peer reviewed journal. The study confirmed the favorable safety profile of Elafin.

No drug related adverse events and no evidence of excessive bleeding, cardiovascular complications or renal dysfunction was reported in this critical patient population. Statistically significant reduction of the area under the curve for plasma troponin I concentration profile over the first 48 h could not be shown in this trial. Post-hoc analysis identified significantly reduced troponin I plasma concentrations by 41% within the first 6 hours after Elafin treatment.