Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin in Coronary Bypass Surgery (EMPIRE Study)
DGAP-News: Proteo Biotech AG / Schlagwort(e): Studie
Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin
in Coronary Bypass Surgery (EMPIRE Study)
11.12.2012 / 12:45
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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:
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@proteo.de
Phone +49(0)431 8888462
Fax: +49(0)431 8888463
Ende der Corporate News
---------------------------------------------------------------------
11.12.2012 Veröffentlichung einer Corporate News/Finanznachricht,
übermittelt durch die DGAP - ein Unternehmen der EquityStory AG.
Für den Inhalt der Mitteilung ist der Emittent / Herausgeber
verantwortlich.
Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten,
Corporate News/Finanznachrichten und Pressemitteilungen.
Medienarchiv unter http://www.dgap-medientreff.de und
http://www.dgap.de
---------------------------------------------------------------------
196652 11.12.2012
DGAP-News: Proteo Biotech AG / Schlagwort(e): Studie
Proteo, Inc. / Proteo Biotech AG: Update for Phase 2 Study of Elafin
in Coronary Bypass Surgery (EMPIRE Study)
11.12.2012 / 12:45
---------------------------------------------------------------------
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:
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@proteo.de
Phone +49(0)431 8888462
Fax: +49(0)431 8888463
Ende der Corporate News
---------------------------------------------------------------------
11.12.2012 Veröffentlichung einer Corporate News/Finanznachricht,
übermittelt durch die DGAP - ein Unternehmen der EquityStory AG.
Für den Inhalt der Mitteilung ist der Emittent / Herausgeber
verantwortlich.
Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten,
Corporate News/Finanznachrichten und Pressemitteilungen.
Medienarchiv unter http://www.dgap-medientreff.de und
http://www.dgap.de
---------------------------------------------------------------------
196652 11.12.2012