Top-line data expected in the First Quarter of 2014
IRVINE, CA, USA I KIEL, Germany I November 8, 2013 I 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.
TEMPIRE (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.”
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) 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).
SOURCE: Proteo
Post Views: 32
Top-line data expected in the First Quarter of 2014
IRVINE, CA, USA I KIEL, Germany I November 8, 2013 I 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.
TEMPIRE (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.”
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) 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).
SOURCE: Proteo
Post Views: 32
