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Proteo Inc.
Proteo Inc.
06/22/2012 | Press release
Proteo, Inc. / Proteo Biotech AG: 50% of Patients are enrolled and the planned interim safety analysis is successfully completed
distributed by noodls on 06/22/2012 20:10
Press release
Proteo, Inc. / Proteo Biotech AG:
Update for Phase 2 Study of Elafin in Coronary Bypass
Surgery (EMPIRE Study)
50% of Patients are enrolled and the planned interim safety analysis is successfully completed
Irvine, CA - Kiel, June 22, 2012. - Proteo, Inc. (OTCQB: PTEO; Freiverkehr Frankfurt: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today: The planned interim safety analysis of the EMPIRE study has already been conducted. No safety concerns were raised by the Data Monitoring Committee and the continuation of the trial was recommended. The recruitment has been especially impressive - fifty percent of the patients have already been treated in the on-going Phase 2 clinical trial in coronary bypass surgery.
The EMPIRE study (Elafin Myocardial Protection from Ischaemia Reperfusion Injury) - a placebo-controlled, double-blinded, monocentric Phase 2 study with 80 patients - has been started in the third quarter of 2011. The study investigates the efficacy of the naturally occurring human protease inhibitor Elafin in preventing complications of coronary bypass surgery with focus on cardiac muscle injury. The study is funded by the Medical Research Council (MRC) and Chest Heart & Stroke Scotland (CHSS) with funding in excess of 500,000 GBP.
"We are very excited with the enrollment progress made in the EMPIRE Phase 2 clinical trial," said Birge Bargmann, CEO of Proteo. "The cooperation with the study centre is going very well and we are confident that the anticipated schedule for the study will be kept."
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. "It's very exciting to be in this position and to be at the point where something that I worked on ten years ago in the tissue culture labs is now being administered to patients" said Peter Henriksen.
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).
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).
Contact:
Barbara Kahlke, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
D-24106 Kiel
Email: info@proteo.de
Telephone: +49 431 8888462
Fax: +49 431 8888463
