75% of patients enrolled - Approval for EMPIRE sub-study
Irvine, CA – Kiel, December 11, 2012. – Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary Proteo Biotech AG announced today: Patient recruitment for the EMPIRE study has surpassed expectations – 75 percent of the patients have already been enrolled in the on- going trial on coronary bypass surgery. Moreover, the Edinburgh study team has received approvals for an EMPIRE sub-study in which 10 healthy volunteers will have a magnetic resonance imaging (MRI) scan, a feraheme infusion and a second MRI scan 24 hours later. This sub-study is designed to aid the interpretation of the imaging findings in the EMPIRE patients.
“We are very excited about the rapid progress in patient enrollment, and are confident that the EMPIRE study will deliver results more quickly than anticipated” said Birge Bargmann, CEO of Proteo. “I would like to take the opportunity to express my gratitude to all the people who are either directly involved in, or work behind the scenes of the EMPIRE study. My particular thanks go to the patients, as it is their willingness to participate that makes it possible to conduct this promising study.”
The EMPIRE study (Elafin Myocardial Protection from Ischaemia Reperfusion Injury) – a placebo-controlled, double-blinded Phase 2 study with 80 patients – was started in the third quarter of 2011. The study is investigating the efficacy of the naturally occurring human protease inhibitor Elafin in preventing complications of coronary bypass surgery with a focus on cardiac muscle injury. In June 2012, we announced that the planned interim safety analysis of the EMPIRE study had already been conducted. No safety concerns were raised by the Data Monitoring Committee and the continuation of the trial was recommended. The clinical trial 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 study is 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