Proteo, Inc. /Proteo Biotech AG: FDA Grants Orphan Drug Designation to Elafin for Prevention of Inflammatory Complications of...
March 20 2013 - 1:41PM
Business Wire
Proteo, Inc. (OTCQB: PTEO) and its wholly-owned subsidiary
Proteo Biotech AG announced today: The U.S. Food and Drug
Administration (FDA) has granted orphan drug designation to Elafin
for the prevention of inflammatory complications of transthoracic
esophagectomy.
Transthoracic esophagectomy is a surgical procedure that
potentially offers a cure for esophagus cancer if the cancer has
not spread beyond the esophagus. This serious operation lasts for
several hours and carries the risk of numerous inflammatory
complications that generally result in high postoperative morbidity
requiring intensive care.
Proteo’s Elafin is a copy of a naturally occurring human
anti-inflammatory protein. In a multicenter Phase II clinical trial
on patients undergoing transthoracic esophagectomy for the
treatment of esophagus carcinoma it was demonstrated that
preoperatively administered Elafin had positive effects on
postoperative morbidity and significantly reduced the required
period of intensive care. "Current options for prevention of
postoperative morbidity due to inflammatory complications are
rather limited and we hope that Elafin may help surgeons to reduce
postoperative complications and help the patients to recover
earlier", said Proteo`s Medical Director Oliver Wiedow.
The orphan drug designation was established to encourage
development of drugs that support the diagnosis, prevention or
treatment of a medical condition affecting fewer than 200,000
people in the U.S. The designation provides U.S. market exclusivity
for a seven-year period upon marketing approval for the designated
indication and tax credits for clinical research costs. Proteo`s
CEO Birge Bargmann: "The addition of FDA orphan designation to the
existing European orphan designation is an excellent basis for
extending the current clinical development program on Elafin for
this condition to the United States."
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 (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.
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