Proteo, Inc./Proteo Biotech AG: Start of the Phase II clinical trial with Elafin
November 17 2008 - 8:40AM
Business Wire
Proteo Inc. (OTCBB: PTEO; WKN: 925981) and its wholly-owned
subsidiary Proteo Biotech AG announced today the beginning of
patient recruitment for a Phase II clinical trial. In this
randomized, placebo-controlled Phase II trial the effect of Elafin
on inflammatory parameters will be investigated in patients
undergoing esophagectomy for esophagus carcinoma. The trial will be
performed under the direction of Prof. Fred F�ndrich, Department of
General and Thoracic Surgery, University of Kiel: �The removal of
the esophagus for esophageal cancer is a very invasive surgical
procedure that frequently requires long stays in intensive care
units. No drugs are currently available which substantially
alleviate the inflammatory reaction of the body to this surgical
treatment. I am therefore particularly pleased that we have the
opportunity to conduct the first clinical trial worldwide on the
therapeutic efficacy of the drug candidate Elafin.� �As the second
largest university hospital in Germany, the University Hospital of
Schleswig-Holstein offers an ideal infrastructure for performing a
trial of this type. We are confident that the results of the trial
will provide confirmation of the mode of action (proof of concept)
and so promote our multifaceted development program for Elafin,�
announced Birge Bargmann, CEO of Proteo. Prof. Oliver Wiedow, who
discovered Elafin and founded Proteo, draws a positive balance:
�With the start of this trial we are also setting a new milestone
for biotechnology in Kiel. The close cooperation of many committed
colleagues at the University Hospital, the state's economic
development fund and Proteo Biotech AG, has made it possible to
promote in Schleswig-Holstein the development of a pharmaceutical,
that was discovered in the Department of Dermatology at the
University of Kiel, and to make this drug substance available for
the first time to patients within the framework of a clinical
trial.� About Elafin The drug candidate Elafin is produced
naturally in humans and inhibits enzymes responsible for the
formation of circulating factors (cytokines) that promote
inflammatory reactions. The release of these cytokines is increased
after major surgery and is responsible for an inflammatory reaction
that can affect all vital organs. In the planned trial it is
expected that Elafin will impair the formation of these cytokines
and thus have a positive effect on the inflammatory reaction. The
excellent tolerability of Elafin in human subjects was demonstrated
in a Phase I clinical single dose escalating study. On
recommendation of the European Medicines Agency (EMEA), Proteo
Biotech AG received orphan drug status from the EU commission for
its candidate drug Elafin for the treatment of pulmonary arterial
hypertension (PAH) and chronic thromboembolic pulmonary
hypertension. About Proteo The company researches, develops and
markets compounds for biological and medical research as well as
for use as pharmaceuticals. PROTEO holds the production and
utilization rights for recombinant human 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-KSB 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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