Proteo Biotech AG
Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin in Coronary Bypass Surgery (EMPIRE Study)
Proteo Biotech AG / Key word(s): Study Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin in Coronary Bypass Surgery (EMPIRE Study) 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.
Further information on the clinical development program for Elafin 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).
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