Proteo, Inc. / Proteo Biotech AG: FDA grants Proteo Orphan Drug Designation to Elafin for the treatment of pulmonary arterial...
January 10 2013 - 8:00AM
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 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.
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