Irvine, CA – Kiel, 16th August, 2011. – Proteo, Inc. (OTCQB: PTEO; Freiverkehr Frankfurt: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today: The first two patients have been recruited into the EMPIRE-Study which will investigate the efficacy of the naturally occurring human protease inhibitor Elafin in preventing complications of coronary bypass surgery. “We are optimistic that Elafin will reduce cardiac muscle injury and post-operative inflammatory responses in patients receiving a bypass”, commented Professor Oliver Wiedow, chairman of the supervisory board of Proteo Biotech AG, a company specializing in the research and development of new pharmaceuticals with emphasis on anti-inflammatory substances.
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. The aim of the study is to investigate the efficacy and safety of intraoperatively administered Elafin in coronary bypass surgery. Inflammation of cardiac muscle and the resulting muscle injury after a bypass operation remain a frequent and unresolved problem.
EMPIRE (Elafin Myocardial Protection from Ischaemia Reperfusion Injury) is a placebo-controlled, double-blinded, monocentric Phase-II study with 80 patients. The study will be funded by the Medical Research Council (MRC) and Chest Heart & Stroke Scotland (CHSS) with funding in excess of 500,000 GBP.
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).
The company researches, develops and markets compounds for biological and medical research as well as for use as pharmaceuticals. The main focus is on anti-inflammatory drugs, in particular on the human protease inhibitor Elafin. Proteo intends to out-license selected indications and to establish international strategic alliances in order to open up new fields of application and for marketing (www.proteo.de).
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.
Barbara Kahlke, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
Telephone: +49 431 8888-462
Fax: +49 431 8888-463