Proteo, Inc. / Proteo Biotech AG: Major advances in the elafin development program for lung diseases
NIH supports research on Elafin with a $10.8 million grant
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.
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.
PROTEO Biotech AG
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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