Proteo, Inc. / Proteo Biotech AG: FDA grants Proteo Orphan Drug Designation to Elafin for the treatment of pulmonary arterial hypertension
DGAP-News: Proteo Biotech AG / Schlagwort(e):
Sonstiges/Zwischenbericht
Proteo, Inc. / Proteo Biotech AG: FDA grants Proteo Orphan Drug
Designation to Elafin for the treatment of pulmonary arterial
hypertension
10.01.2013 / 11:30
---------------------------------------------------------------------
Proteo, Inc. / Proteo Biotech AG: FDA grants Proteo Orphan Drug Designation
to Elafin for the treatment of pulmonary arterial hypertension
Irvine, CA - Kiel, January 10, 2013 - 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 treatment of pulmonary arterial hypertension.
Orphan Drug designation is granted by the FDA Office of Orphan Drug
Products to novel drugs to treat a rare disease or condition affecting
fewer than 200,000 persons in the United States. The designation provides
the drug developer with a seven year term of market exclusivity upon final
FDA approval. Moreover, this designation offers tax credits on certain
development costs in the US and a waiver of the new drug application (NDA)
user fee and opens the door to special funding opportunities, such as the
US Orphan Products Grants Program.
Pulmonary arterial hypertension (PAH) is a life-threatening disease in
which the pressure in a patient's pulmonary arteries becomes dangerously
high. If untreated, patients have a 40% five-year survival. While the
advent of new therapies has likely improved survival to approximately 60%,
there remains no specific cure for the disease. Despite the treatment
progress during the last two decades there is still an unmet medical need
for additional treatments.
Proteo's Elafin blocks the activity of enzymes that are involved in
pulmonary arterial hypertension. This makes Elafin a highly promising
compound for the treatment of the disease with a new mode of action. In
preclinical studies at Stanford University, the treatment with Elafin
attenuated fully developed PAH in an animal model with a pronounced and
significant improvement of the vascular pathology, parameters of pulmonary
hemodynamics, and right ventricular function. 'In humans, the obliteration
of distal pulmonary arteries leads to a severe increase in pulmonary artery
pressure and subsequently to right ventricular dysfunction. Reversal of
this obliteration is a key goal in the treatment of PAH. We therefore
propose that Elafin treatment could be a promising option for PAH
patients.' said Marlene Rabinovitch, Director of Research, Vera Moulton
Wall Center for Pulmonary Vascular at Stanford University School of
Medicine.
Birge Bargmann, CEO of Proteo: 'We are very pleased that Marlene
Rabinovitch, a leading specialist in the field of pulmonary arterial
hypertension, and her team have supported this application. Elafin has now
obtained orphan drug status for the treatment of PAH in the US and in the
European Union which is an important milestone on the way towards the
clinical development of Elafin in both regions'.
Further information on the clinical development program for Elafin:
Proteo's pharmaceutical Elafin is a copy of a naturally occurring human
anti-inflammatory substance. It is a natural antagonist of the tissue
destroying enzymes (proteases) that participate in the inflammatory
mechanism of many diseases. Elafin's ability to block the enzymes that
cause these undesirable effects makes it a promising drug for the treatment
of e.g. inflammatory lung diseases and severe reperfusion injury. The
excellent tolerability of intravenously administered recombinant Elafin has
already been demonstrated convincingly in a Phase I clinical trial. The
outcome of a Phase II clinical trial on the treatment of postoperative
inflammatory reactions in esophagus carcinoma show that intravenously
administered Elafin has a very clear positive effect on the period of
recovery: 63 percent of the Elafin treated patients required only one day
of intensive care. All patients in the placebo group needed several days of
postoperative intensive medical care. In addition, Proteo's licensing and
development partner, Minapharm Pharmaceuticals SAE, has initiated a Phase
II clinical trial on the use of Elafin for kidney transplantation patients.
This trial is concerned with the prevention of acute organ rejection and
chronic graft injury (allograft nephropathy). A further clinical trial -
EMPIRE (Elafin Myocardial Protection from Ischaemia Reperfusion Injury), a
placebo-controlled, double-blinded Phase-II study with 80 patients - has
been started in the third quarter of 2011. The study is being performed
under the supervision of the cardiologist Dr. Peter Henriksen at NHS
Lothian's Edinburgh Heart Centre in association with The University of
Edinburgh, one of the leading European universities in the area of
cardiovascular research.
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.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-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
Germany
Email: info@proteo.de
Phone +49(0)431 8888462
Fax: +49(0)431 8888463
Ende der Corporate News
---------------------------------------------------------------------
10.01.2013 Veröffentlichung einer Corporate News/Finanznachricht,
übermittelt durch die DGAP - ein Unternehmen der EquityStory AG.
Für den Inhalt der Mitteilung ist der Emittent / Herausgeber
verantwortlich.
Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten,
Corporate News/Finanznachrichten und Pressemitteilungen.
Medienarchiv unter http://www.dgap-medientreff.de und
http://www.dgap.de
---------------------------------------------------------------------
198750 10.01.2013
DGAP-News: Proteo Biotech AG / Schlagwort(e):
Sonstiges/Zwischenbericht
Proteo, Inc. / Proteo Biotech AG: FDA grants Proteo Orphan Drug
Designation to Elafin for the treatment of pulmonary arterial
hypertension
10.01.2013 / 11:30
---------------------------------------------------------------------
Proteo, Inc. / Proteo Biotech AG: FDA grants Proteo Orphan Drug Designation
to Elafin for the treatment of pulmonary arterial hypertension
Irvine, CA - Kiel, January 10, 2013 - 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 treatment of pulmonary arterial hypertension.
Orphan Drug designation is granted by the FDA Office of Orphan Drug
Products to novel drugs to treat a rare disease or condition affecting
fewer than 200,000 persons in the United States. The designation provides
the drug developer with a seven year term of market exclusivity upon final
FDA approval. Moreover, this designation offers tax credits on certain
development costs in the US and a waiver of the new drug application (NDA)
user fee and opens the door to special funding opportunities, such as the
US Orphan Products Grants Program.
Pulmonary arterial hypertension (PAH) is a life-threatening disease in
which the pressure in a patient's pulmonary arteries becomes dangerously
high. If untreated, patients have a 40% five-year survival. While the
advent of new therapies has likely improved survival to approximately 60%,
there remains no specific cure for the disease. Despite the treatment
progress during the last two decades there is still an unmet medical need
for additional treatments.
Proteo's Elafin blocks the activity of enzymes that are involved in
pulmonary arterial hypertension. This makes Elafin a highly promising
compound for the treatment of the disease with a new mode of action. In
preclinical studies at Stanford University, the treatment with Elafin
attenuated fully developed PAH in an animal model with a pronounced and
significant improvement of the vascular pathology, parameters of pulmonary
hemodynamics, and right ventricular function. 'In humans, the obliteration
of distal pulmonary arteries leads to a severe increase in pulmonary artery
pressure and subsequently to right ventricular dysfunction. Reversal of
this obliteration is a key goal in the treatment of PAH. We therefore
propose that Elafin treatment could be a promising option for PAH
patients.' said Marlene Rabinovitch, Director of Research, Vera Moulton
Wall Center for Pulmonary Vascular at Stanford University School of
Medicine.
Birge Bargmann, CEO of Proteo: 'We are very pleased that Marlene
Rabinovitch, a leading specialist in the field of pulmonary arterial
hypertension, and her team have supported this application. Elafin has now
obtained orphan drug status for the treatment of PAH in the US and in the
European Union which is an important milestone on the way towards the
clinical development of Elafin in both regions'.
Further information on the clinical development program for Elafin:
Proteo's pharmaceutical Elafin is a copy of a naturally occurring human
anti-inflammatory substance. It is a natural antagonist of the tissue
destroying enzymes (proteases) that participate in the inflammatory
mechanism of many diseases. Elafin's ability to block the enzymes that
cause these undesirable effects makes it a promising drug for the treatment
of e.g. inflammatory lung diseases and severe reperfusion injury. The
excellent tolerability of intravenously administered recombinant Elafin has
already been demonstrated convincingly in a Phase I clinical trial. The
outcome of a Phase II clinical trial on the treatment of postoperative
inflammatory reactions in esophagus carcinoma show that intravenously
administered Elafin has a very clear positive effect on the period of
recovery: 63 percent of the Elafin treated patients required only one day
of intensive care. All patients in the placebo group needed several days of
postoperative intensive medical care. In addition, Proteo's licensing and
development partner, Minapharm Pharmaceuticals SAE, has initiated a Phase
II clinical trial on the use of Elafin for kidney transplantation patients.
This trial is concerned with the prevention of acute organ rejection and
chronic graft injury (allograft nephropathy). A further clinical trial -
EMPIRE (Elafin Myocardial Protection from Ischaemia Reperfusion Injury), a
placebo-controlled, double-blinded Phase-II study with 80 patients - has
been started in the third quarter of 2011. The study is being performed
under the supervision of the cardiologist Dr. Peter Henriksen at NHS
Lothian's Edinburgh Heart Centre in association with The University of
Edinburgh, one of the leading European universities in the area of
cardiovascular research.
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.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-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
Germany
Email: info@proteo.de
Phone +49(0)431 8888462
Fax: +49(0)431 8888463
Ende der Corporate News
---------------------------------------------------------------------
10.01.2013 Veröffentlichung einer Corporate News/Finanznachricht,
übermittelt durch die DGAP - ein Unternehmen der EquityStory AG.
Für den Inhalt der Mitteilung ist der Emittent / Herausgeber
verantwortlich.
Die DGAP Distributionsservices umfassen gesetzliche Meldepflichten,
Corporate News/Finanznachrichten und Pressemitteilungen.
Medienarchiv unter http://www.dgap-medientreff.de und
http://www.dgap.de
---------------------------------------------------------------------
198750 10.01.2013