Proteo Inc./Proteo Biotech AG: Successful completion of patient recruitment for the Phase II clinical trial on Elafin in pati...
April 23 2010 - 8:47AM
Business Wire
Proteo, Inc. (OTCBB: PTEO; WKN: 925981) and its wholly-owned
subsidiary Proteo Biotech AG announced today the successful
completion of patient recruitment for the Phase II clinical trial
on the intravenously administered study drug Elafin. In this
blinded, randomized, controlled Phase II clinical trial the effect
of Elafin on the postoperative inflammatory reaction is being
investigated in patients undergoing esophagectomy for esophagus
carcinoma. The trial is being conducted at 3 German university
hospitals - Kiel, TU-Munich and Muenster. Birge Bargmann, CEO of
Proteo: "We expect to have preliminary data on the efficacy of our
elastase inhibitor in the near future and we are optimistic that
the results of the trial will meet our expectations."
In January of this year, on recommendation of the European
Medicines Agency EMEA, Orphan Drug Status was awarded to Proteo by
the European Commission for the use of Elafin in the treatment of
esophagus carcinoma. Classification as an orphan drug allows an
accelerated approval procedure in all EU states. After presentation
of the trial results Proteo will consult the European Medicines
Agency EMEA, which is responsible for the centralized European
approval procedure, for scientific advice regarding the
requirements for a further trial which is planned at the end of
2010.
Further information on the clinical development program for
Elafin:
Proteo's drug substance Elafin is a natural human antagonist of
elastase and proteinase-3, two potent tissue destroying enzymes,
both of which participate in the inflammatory mechanism of a
variety of diseases. Elafin's ability to block these inflammation
promoting enzymes makes it a promising drug candidate for the
treatment of inflammatory lung diseases and severe reperfusion
injury. The excellent tolerability of intravenously administered
recombinant Elafin was demonstrated convincingly in a Phase I
clinical trial. In addition to the above mentioned trial on
esophagus carcinoma, Proteo's licensing and development partner,
Minapharm Pharmaceuticals SAE, has initiated a further Phase II
clinical trial on the use of Elafin in 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. As a further
cooperation partner, the University of Edinburgh is planning a
clinical trial to test Elafin in the context of bypass surgery
after a heart attack.
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 elastase inhibitor Elafin. Proteo intends
to out-license selected indications and to stablish international
strategic alliances in order to open up new fields of application
and for marketing.
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.
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