Irvine, CA – Kiel, September 02, 2008 – Proteo, Inc. (OTCBB: PTEO; Frankfurter Freiverkehr: WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today, that the German regulatory authority, the German Federal Institute For Drugs And Medical Devices (BfArM), has granted approval for a Phase II clinical trial on the drug candidate Elafin.
The trial will be conducted as a randomized, blinded, placebo-controlled Phase II trial to investigate the influence of Elafin on the cytokine profile after major surgery. The trial will be performed at the Department of General and Thoracic Surgery, University Medical Center Schleswig-Holstein, Campus Kiel, It is planned to commence patient recruitment in the final quarter of 2008. Initial results are anticipated to be available within the first 6 months of 2009. The aim of the trial is to investigate the therapeutic efficacy of the drug candidate.
“The start of this clinical trial represents an important milestone in the realization of the market potential of our lead-product”, commented Birge Bargmann, CEO of Proteo Biotech AG.
The drug candidate Elafin is produced naturally in humans and inhibits enzymes responsible for the formation of circulating factors (cytokines) that promote inflammatory reactions. The release of these cytokines is increased after major surgery and is responsible for an inflammatory reaction that can affect all vital organs. In the planned trial it is expected that Elafin will impair the formation of these cytokines and thus have a positive effect on the inflammatory reaction.
The excellent tolerability of Elafin in human subjects was demonstrated in a Phase I clinical single dose escalating study. On recommendation of the European Medicines Agency (EMEA), Proteo Biotech AG received orphan drug status from the EU commission for its candidate drug Elafin for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension.
The company researches, develops and markets compounds for biological and medical research as well as for use as pharmaceuticals. PROTEO holds the production and utilization rights for recombinant human 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