DGAP-News: Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin in Coronary Bypass Surgery (EMPIRE Study)
(firmenpresse) - DGAP-News: Proteo Biotech AG / Key word(s): Study/Research Update
Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin
in Coronary Bypass Surgery (EMPIRE Study)
22.06.2012 / 12:24
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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 ongoing 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).
Forward-looking statements:
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.
Contact:
Barbara Kahlke, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
D-24106 Kiel
Germany
Email: info(at)proteo.de
Phone +49(0)431 8888462
Fax: +49(0)431 8888463
End of Corporate News
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Datum: 22.06.2012 - 12:24 Uhr
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