Gil Roth11.08.13
The National Health Service (NHS) Lothian’s Edinburgh Heart Centre has successfully completed patient recruitment and treatment for the Phase II trial of Elafin for prevention of myocardial injury after coronary artery bypass surgery (CABG). Elafin is a drug candidate of Proteo, Inc. and its subsidiary Proteo Biotech AG. Top-line results are expected to be announced in 1Q14.
The study, which began in 3Q11, is a placebo-controlled, double-blinded, Phase II trial to investigate the efficacy and safety of Elafin in coronary bypass surgery. Preoperative Elafin treatment was well tolerated, as no safety concerns were raised by the Data Monitoring Committee in the two planned interim safety analyses. The recruitment period for the study has been closed after a total of 87 participants were randomized.
The Edinburgh study team has conducted a sub-study with 10 healthy volunteers to aid the interpretation of the imaging findings in the trial's patients. Both studies were performed under the supervision of the cardiologist Dr. Peter Henriksen at NHS Lothian’s Edinburgh Heart Centre in association with The University of Edinburgh, one of the leading European universities in the area of cardiovascular research, and the Edinburgh Clinical Trials Unit.
Elafin is a copy of a naturally occurring human anti-inflammatory substance. It is a natural antagonist of the tissue destroying enzymes (proteases) that participate in the inflammatory mechanism of many diseases. Elafin’s ability to block the enzymes that cause these undesirable effects makes it a promising drug for the treatment of e.g. inflammatory lung diseases and severe reperfusion injury.
A Phase II trial of the treatment of postoperative inflammatory reactions in esophagus carcinoma showed that intravenously administered Elafin has a clear positive effect on the period of recovery: 63% of the Elafin-treated patients required only one day of intensive care, while all patients in the placebo group needed several days of postoperative intensive medical care.
Proteo’s licensing and development partner, Minapharm Pharmaceuticals SAE, has initiated a Phase II clinical trial on the use of Elafin for kidney transplantation patients. This trial is concerned with the prevention of acute organ rejection and chronic graft injury (allograft nephropathy) and will be conducted at the University of Cairo.
The study, which began in 3Q11, is a placebo-controlled, double-blinded, Phase II trial to investigate the efficacy and safety of Elafin in coronary bypass surgery. Preoperative Elafin treatment was well tolerated, as no safety concerns were raised by the Data Monitoring Committee in the two planned interim safety analyses. The recruitment period for the study has been closed after a total of 87 participants were randomized.
The Edinburgh study team has conducted a sub-study with 10 healthy volunteers to aid the interpretation of the imaging findings in the trial's patients. Both studies were performed under the supervision of the cardiologist Dr. Peter Henriksen at NHS Lothian’s Edinburgh Heart Centre in association with The University of Edinburgh, one of the leading European universities in the area of cardiovascular research, and the Edinburgh Clinical Trials Unit.
Elafin is a copy of a naturally occurring human anti-inflammatory substance. It is a natural antagonist of the tissue destroying enzymes (proteases) that participate in the inflammatory mechanism of many diseases. Elafin’s ability to block the enzymes that cause these undesirable effects makes it a promising drug for the treatment of e.g. inflammatory lung diseases and severe reperfusion injury.
A Phase II trial of the treatment of postoperative inflammatory reactions in esophagus carcinoma showed that intravenously administered Elafin has a clear positive effect on the period of recovery: 63% of the Elafin-treated patients required only one day of intensive care, while all patients in the placebo group needed several days of postoperative intensive medical care.
Proteo’s licensing and development partner, Minapharm Pharmaceuticals SAE, has initiated a Phase II clinical trial on the use of Elafin for kidney transplantation patients. This trial is concerned with the prevention of acute organ rejection and chronic graft injury (allograft nephropathy) and will be conducted at the University of Cairo.