Proteo, Inc. / Proteo Biotech AG: Patient Recruitment and Treatment in Elafin CABG Phase II Clinical Trial Completed
November 08 2013 - 5:56AM
Business Wire
Top-line data expected in the First Quarter of 2014
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.
The EMPIRE (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).
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.
Proteo Biotech AGBarbara Kahlke, Ph.D.Email:
info@proteo.deTelephone: +49 431 8888-462Fax: +49 431 8888-463
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