Proteo Inc./Proteo Biotech AG: European Medicines Agency EMEA Recommends Orphan Drug Status for Elafin in the Treatment of Es...
November 16 2009 - 4:49AM
Business Wire
Proteo, Inc. (OTCBB: PTEO; Frankfurter Freiverkehr: WKN: 925981)
and its wholly-owned subsidiary Proteo Biotech AG announced
today:
The Committee for Orphan Medical Products (COMP) of the European
Medicines Agency (EMEA) has issued a recommendation granting orphan
drug status to Proteo's drug candidate Elafin for the treatment of
esophagus carcinoma. The orphan drug status will become effective
upon ratification of this recommendation by the European
Commission. This is expected to occur in the last quarter of 2009.
Elafin was also granted orphan drug status for the treatment of
pulmonary arterial hypertension (PAH) and chronic thromboembolic
pulmonary hypertension in 2007. This latest decision further
highlights the considerable therapeutic potential of this drug.
Orphan drug status assures exclusive marketing rights for the
treatment of the respective disease within the EU for a period of
up to ten years after receiving market approval. In addition, a
simplified, accelerated and less expensive approval procedure with
the assistance of EMEA can be drawn upon. Patients undergoing
esophagectomy for esophagus carcinoma are currently being treated
with Elafin within the framework of a Phase II clinical trial. A
follow-up study after completion of this trial in 2010 is already
being planned.
About Elafin:
Proteo's drug substance Elafin is an endogenous protein produced
by the human body and is a natural inhibitor of the two tissue
destroying enzymes, neutrophil elastase and proteinase-3. Both of
these enzymes are known to be involved in the inflammatory response
occurring in a variety of diseases. Elafin's ability to block the
activity of destructive enzymes that are involved in inflammatory
reactions makes it a highly promising active compound for the
treatment of inflammatory lung diseases or severe reperfusion
injuries.
Clinical development:
The excellent tolerability of recombinant Elafin for injection
in human subjects was demonstrated in a Phase I clinical trial. A
Phase II clinical trial on patients undergoing esophagectomy for
esophagus carcinoma has been started in the University Hospital of
Schleswig-Holstein, Campus Kiel in November 2008. The aim of the
trial is to investigate the effectiveness of Elafin at suppressing
the postoperative inflammatory processes. A further Phase II
clinical trial has already been approved: Minapharm Pharmaceuticals
SAE, Cairo, will initiate a Phase II clinical trial to study the
efficacy of Elafin on kidney transplant patients. The study will be
conducted as a Phase II trial for prevention of acute and chronic
allograft nephropathy at the University of Cairo. Within the
framework of a collaboration, it is intended to investigate the
effect of Elafin on the damage and inflammation of cardiac muscle
after coronary bypass operations in a Phase II clinical trial at
the University of Edinburgh.
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 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.
Further information: www.proteo.de
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