Irvine, CA – Kiel, June 27, 2012. – Proteo, Inc. (OTCQB: PTEO; Freiverkehr Frankfurt: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today: An international group of leading clinically active pulmonary researchers from the Departments of Pediatrics of the Universities of Stanford, Munich and Alberta, have published further evidence for the use of Elafin in the treatment of newborn infants whose lungs are incompletely developed.
Mechanical ventilation of preterm babies with oxygen-rich gas offers life-saving treatment for newborn infants with respiratory failure, but can also promote lung injury with a considerable risk of chronic lung disease in later life. One reason for this is that lung elastin, a key determinant of lung growth and repair, is disordered by mechanical ventilation. A therapeutic agent to prevent ventilator-induced neonatal lung injury would be very helpful for the support of premature infants and improvement of their prognosis.
In the context of their work on the adverse effects of mechanical ventilation on neonatal lung development, the scientists worked with neonatal mice genetically modified to produce Elafin in their vasculature. These mice were almost completely protected against ventilator-induced lung inflammation and the structural damage to their lungs was attenuated. The results of this transgenic animal model confirm previous findings in which administration of Elafin to wild-type animals had similar effects.
The results strongly suggest that degradation and remodeling of lung elastin can contribute to defective lung growth in response to mechanical ventilation and the authors surmise that this degradation might be targeted therapeutically by Elafin.
Further research on this topic is in progress at Stanford University, funded by grant from the National Heart, Lung and Blood Institute for the study of Elafin’s ability to treat three distinct lung diseases.
Dr. Oliver Wiedow, who discovered Elafin and founded Proteo: “We are very confident that these results in animal models can be further substantiated within the framework of the ongoing intensive research and we hope very much that one day Elafin will support newborn infants with incompletely developed lungs”.
Anne Hilgendorff, Kakoli Parai, Robert Ertsey, G Juliana Rey-Parra, Bernard Thébaud, Rasa Tamosiuniene, Noopur Jain, Edwin F Navarro, Barry C Starcher, Mark R Nicolls, Marlene Rabinovitch, and Richard D Bland: Neonatal Mice Genetically Modified to Express the Elastase Inhibitor Elafin are Protected Against the Adverse Effects of Mechanical Ventilation on Lung Growth. Am J Physiol Lung Cell Mol Physiol 2012 [epub ahead of print, article in press].
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.
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).
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.
Barbara Kahlke, Ph.D.
Proteo Biotech AG
Am Kiel-Kanal 44
Telephone: +49 431 8888-462
Fax: +49 431 8888-463