Pressemitteilung
Major advances in the elafin development program for lung diseases - NIH supports research on Elafin with a $10.8 million grant
Irvine, CA - Kiel, December 6, 2011. - Proteo, Inc. (OTCQB: PTEO; Freiverkehr Frankfurt: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today: Since 2008, the Company cooperates with scientists at Stanford University in California with respect to the preclinical development in the field of pulmonary arterial hypertension and ventilator-induced lung injury. In August 2010 the cooperation agreement with Stanford University was extended by a further project on lung transplantation.
In 2011 the Stanford team led by Marlene Rabinovitch and Richard Bland published two major advances in research on pulmonary arterial hypertension and ventilator-induced lung injury in the American Journal of Pathology and the American Journal of Respiratory and Critical Care Medicine: They showed for the first time in an animal model of pulmonary arterial hypertension that human leukocyte elastase is produced by pulmonary arterial smooth muscle cells. Administration of Proteo's elastase inhibitor Elafin attenuated the development of the typical vascular lesions for this disease, pointing towards a therapeutic potential of Elafin. In independent experiments they showed that intratracheal Elafin treatment attenuated lung structural abnormalities noted in mechanically ventilated newborn mice. These findings support the assumption that Elafin might be used therapeutically to prevent ventilator-induced lung injury in newborns.
In the third quarter of 2011 the Stanford School of Medicine research team led by Marlene Rabinovitch, MD, has been awarded a five-year, $10.8 million grant from the National Heart, Lung and Blood Institute for the study of Elafin's ability to treat pulmonary arterial hypertension, ventilator-induced lung injury in newborns and lung transplant rejections.
The Stanford team will test whether Elafin prevents such lung damage or promotes healing of damaged tissue in these three lung diseases. The grant will fund one project for each disease, all three of which are notoriously difficult to treat. Rabinovitch will lead Project 1 on pulmonary hypertension, or elevated blood pressure in the arteries that supply blood to the lungs, which kills more than 60 percent of patients within five years of diagnosis. Project 2 will focus on ventilator-induced injury of the immature lung, which causes lasting lung damage in premature babies. This project will be led by Richard Bland, MD, Professor in the Division of Newborn Medicine of the Department of Pediatrics at Stanford. Project 3, which is to be led by Mark Nicolls, MD, associate professor of pulmonary and critical care medicine and chief of the Division of Pulmonary and Critical Care Medicine, examines chronic lung transplant rejection, which leads lung transplant recipients to have the worst survival statistics of all organ recipients.
"Our project was sparked by exciting preclinical data indicating that the elastase inhibitor Elafin can be used to treat three of the most challenging lung conditions: pulmonary hypertension, ventilator-induced injury of the immature lung and lung transplant rejection," said Rabinovitch, who is Professor of Pediatrics in the Division of Pediatric Cardiology at Stanford's Lucile Packard Children's Hospital.
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, monocentric 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. The study is funded by the
Medical Research Council (MRC) and Chest Heart & Stroke
Scotland (CHSS) with funding in excess of 500,000 GBP.
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).
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