Irvine, CA – Kiel, 23rd February 2011. – Proteo, Inc. (OTCBB: PTEO; Freiverkehr Frankfurt and Berlin WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG disclosed results of a Phase II clinical trial on the candidate drug Elafin today.
The effect of Elafin on the postoperative inflammatory reaction occurring in cancer patients whose esophagus has been removed was investigated at the University Hospitals in Kiel, Münster and Munich. This serious operation (esophagectomy), which lasts for several hours, carries the risk of numerous specific complications that generally result in a prolonged period of intensive care. The results of the trial 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. “These results have fully met our optimistic expectations”, commented Birge Bargmann, CEO of Proteo Biotech AG. Detailed results from this multicenter, blinded, randomized and placebo-controlled trial are to be published in a scientific journal.
In January 2010, on recommendation of the European Medicines Agency (EMA), the European Commission granted Proteo Biotech AG “orphan drug status” for Elafin in the treatment of esophagus carcinoma.
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, for example, 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. In addition to the clinical trial on esophagus carcinoma described above, Proteo’s licensing and development partner, Minapharm Pharmaceuticals SAE, has initiated another Phase II clinical trial for the use of Elafin on kidney transplant patients. This trial is concerned with the prevention of acute organ rejection and chronic graft injury (allograft nephropathy). As a further cooperation partner, the University of Edinburgh is initiating a clinical trial to test Elafin in bypass operations after heart attacks. This study is being supported by the Medical Research Council (MRC) and the Chest, Heart and Stroke Scotland (CHSS) with 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. The lead product is 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