Proteo, Inc. / Proteo Biotech AG: Final Analysis of the Phase II Clinical Study on Elafin in Coronary Artery Bypass Surgery C...
November 21 2014 - 5:30AM
Business Wire
Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary
Proteo Biotech AG today announced that the NHS Lothian’s Edinburgh
Heart Centre has completed final analysis of data from the
investigator initiated Phase II clinical trial (EMPIRE study) with
Proteo’s drug candidate Elafin for prevention of myocardial injury
after coronary artery bypass surgery (CABG). The EMPIRE study was
designed as a randomized, double-blinded and placebo-controlled
study on 87 patients to investigate the therapeutic potential of a
single preoperative Elafin dose on postoperative myocardial injury.
This was measured by troponin I plasma concentration which is
released by damaged heart muscle cells and its plasma concentration
correlates with overall damage of the heart muscle. It was assumed
that this treatment would lower the troponin I release over 48
hours. Publication of the EMPIRE study results is planned in a peer
reviewed journal.
The study confirmed the favorable safety profile of Elafin. No
drug related adverse events and no evidence of excessive bleeding,
cardiovascular complications or renal dysfunction was reported in
this critical patient population. Statistically significant
reduction of the area under the curve for plasma troponin I
concentration profile over the first 48 h could not be shown in
this trial. Post-hoc analysis identified significantly reduced
troponin I plasma concentrations by 41% within the first 6 hours
after Elafin treatment. "An unexpected skewed distribution of
troponin I plasma concentrations in the patient groups was observed
in the study and consequently the study turned out to be
underpowered," said principal investigator cardiologist Dr. Peter
Henriksen at NHS Lothian's Edinburgh Heart Centre. "This
contradicts observations from an earlier UK study in CABG surgery
patients which was taken as a reference for the study design and
sample size calculation. This study provides sufficient information
for design of an adequately powered follow up study with an
indication that multiple doses in the postoperative period may be
more effective." Professor Oliver Wiedow, Director of Proteo, Inc.,
said: "I would like to thank the investigators and their co-workers
for this proof of concept study initiative. Results from this study
contribute to our understanding of the therapeutic potential of
Elafin and the time course of reperfusion injury in CABG. The
results confirm the favorable safety profile of Elafin and
additionally there are indications that Elafin has a beneficial
effect on the protection of heart muscle tissue as long as Elafin
is present in the blood."
About coronary artery bypass surgery
CABG remains the treatment of choice for patients with complex
multi-vessel coronary artery disease and improves symptoms and
survival. During CABG and cardiopulmonary bypass, coronary blood
flow is interrupted and the heart is put into circulatory arrest.
This causes ischemia-reperfusion injury that is dominated by
adverse neutrophil-mediated myocardial inflammation and injury.
CABG surgery therefore represents a programmed clinical model of
ischemia-reperfusion injury that lends itself to testing the
efficacy of potential therapeutic interventions.
About 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 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. The Company has already received scientific
advice for orphan medicines from the Committee for Medicinal
Products for Human Use (CHMP) at the European Medicines Agency
(EMA) for conducting a pivotal clinical trial with Elafin for the
prophylactic treatment of acute postoperative complications after
resection of esophageal cancer (“POSTCOM TRIAL”).
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. Proteo Biotech AG, Kiel, Germany (www.proteo.de)
is a fully-owned subsidiary of Proteo Inc., Irvine, California
(www.proteo.us).
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.Telephone: +49 431
8888-462Fax: +49 431 8888-463Email: info@proteo.de
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