DGAP-News: Proteo Inc./Proteo Biotech AG: Successful completion of patient recruitment for the Phase II clinical trial on Elafin in patients with esophagus cancer
(firmenpresse) - Proteo Biotech AG / Preliminary Results/Research Update
23.04.2010 14:12
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Irvine, CA - Kiel, April 23, 2010 - 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 elastaseand 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.
Contact:
Barbara Kahlke, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
D-24106 Kiel
Email : info(at)proteo.de
Telephone: +49(0)431 8888462
Fax : +49(0)431 8888463
23.04.2010 14:12 Ad hoc announcement, Financial News and Media Release distributed by DGAP. Medienarchiv atwww.dgap-medientreff.deandwww.dgap.de---------------------------------------------------------------------------
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Datum: 23.04.2010 - 14:12 Uhr
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