Top-line data expected in the First Quarter of 2014
Irvine, CA - Kiel, November 8, 2013 - Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG today announced that the NHS Lothian’s Edinburgh Heart Centre has successfully completed patient recruitment and treatment for the Phase II clinical trial (EMPIRE study) with Proteo’s drug candidate Elafin for prevention of myocardial injury after coronary artery bypass surgery (CABG). According to plan top-line results from this trial are expected to be announced in the first quarter of 2014.
The EMPIRE (Elafin Myocardial Protection from Ischaemia Reperfusion Injury) study is a placebo-controlled, double-blinded, Phase 2 clinical trial to investigate the efficacy and safety of Elafin in coronary bypass surgery which was started in the third quarter of 2011. The 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 EMPIRE study is now closed after a total of 87 participants have been randomised. In addition, the Edinburgh study team has already conducted an EMPIRE sub-study with 10 healthy volunteers to aid the interpretation of the imaging findings in the EMPIRE 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.
Birge Bargmann, CEO of Proteo: "I am very pleased with how efficiently the EMPIRE study has been conducted." Dr. Peter Henriksen, principle investigator of the EMPIRE study: "We look forward to evaluating and reporting the study results in the near future. Demonstration of Elafin's efficacy in preventing complications of coronary bypass surgery would pave the way to an innovative preventive therapy to improve the outcome of patients undergoing treatment for coronary artery disease."
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) and will be conducted at the University of Cairo. About Proteo 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