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Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin in Coronary Bypass Surgery (EMPIRE Study)
50% of Patients are enrolled and the planned interim safety analysis is successfully completed(PresseBox) ( Irvine, CA/Kiel, )
The EMPIRE study (Elafin Myocardial Protection from Ischaemia Reperfusion Injury) - a placebo-controlled, double-blinded, monocentric Phase 2 study with 80 patients - has been started in the third quarter of 2011. The study investigates the efficacy of the naturally occurring human protease inhibitor Elafin in preventing complications of coronary bypass surgery with focus on cardiac muscle injury. The study is funded by the Medical Research Council (MRC) and Chest Heart & Stroke Scotland (CHSS) with funding in excess of 500,000 GBP.
"We are very excited with the enrollment progress made in the EMPIRE Phase 2 clinical trial," said Birge Bargmann, CEO of Proteo. "The cooperation with the study centre is going very well and we are confident that the anticipated schedule for the study will be kept."
The study is being 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. "It's very exciting to be in this position and to be at the point where something that I worked on ten years ago in the tissue culture labs is now being administered to patients" said Peter Henriksen
Further information on the clinical development program for Elafin
Proteo's pharmaceutical 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. The excellent tolerability of intravenously administered recombinant Elafin has already been demonstrated convincingly in a Phase I clinical trial. The outcome of a Phase II clinical trial on the treatment of postoperative inflammatory reactions in esophagus carcinoma show that intravenously administered Elafin has a very clear positive effect on the period of recovery: 63 percent of the Elafin treated patients required only one day of intensive care. All patients in the placebo group needed several days of postoperative intensive medical care. In addition, 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).
Certain statements in this news release may contain forward-looking information within the meaning of Rule 175 under the Securities Act of 1933 and Rule 3b-6 under the Securities Exchange Act of 1934, and are subject to the safe harbor created by those rules. All statements, other than statements of fact included in this release, including, without limitation, statements regarding potential future plans and objectives of the company, are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Technical complications that may arise could prevent the prompt implementation of any strategically significant plan(s) outlined above. The company cautions that these forward looking statements and risks and uncertainties involved are further qualified by other factors including, but not limited to those set forth in the company's Form 10-K filing and other filings with the United States Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any statements in this release, whether as a result of new information, future events or otherwise.
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