Irvine, CA – Kiel, 17th Feb., 2009 – Proteo, Inc. (OTCBB: PTEO; WKN: 925981), and its wholly-owned subsidiary Proteo Biotech AG announced today: In the context of their work on the causes of acute respiratory distress syndrome (ARDS), the research group of David Christiani at the Harvard School of Public Health has established that in many ARDS patients insufficient amounts of the protective protein Elafin are formed during the initial phases of the disease. In their most recent clinical study, funded by the National Institutes of Health (National Heart, Lung and Blood Institute) involving 148 patients, the American researchers showed that the level of Elafin at the onset of acute respiratory failure is about 40% lower. Dr. Christiani stated: »These results support our hypothesis that the therapeutic administration of Elafin could serve as a specific treatment for acute respiratory distress syndrome.«
Acute respiratory distress is characterized by extensive and diffuse injury of the lung, due to a reaction to various damaging factors. It is a considerable problem in intensive care medicine and the majority of patients have to be ventilated for long periods of time. The incidence of ARDS is up to 28 cases per 100,000 inhabitants per year. Although the mortality rate has been reduced by advances in treatment over recent decades, it is still around 40%.
Proteo's drug substance Elafin is an endogenous protein produced by the human body and is a natural inhibitor of the two tissue destroying enzymes, neutrophil elastase and proteinase-3. Both of these enzymes are known to be involved in the inflammatory response occurring in a variety of diseases. Elafin's ability to block the activity of destructive enzymes that are involved in inflammatory reactions makes it a highly promising active compound for the treatment of inflammatory lung diseases or severe reperfusion injuries. The excellent tolerability of recombinant Elafin for injection in human subjects was demonstrated in a Phase I clinical trial. A Phase II clinical trial on patients undergoing esophagectomy for esophagus carcinoma has been started in the University Hospital of Schleswig-Holstein, Campus Kiel in November 2008 . The aim of the trial is to investigate the effectiveness of Elafin at suppressing the postoperative inflammatory processes. A further Phase II clinical trial has already been approved: Minapharm Pharmaceuticals SAE, Cairo, will initiate a Phase II clinical trial to study the efficacy of Elafin on kidney transplant patients. The study will be conducted as a Phase II trial for prevention of acute and chronic allograft nephropathy at the University of Cairo.
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 elastase 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-KSB 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