Proteo, Inc./Proteo Biotech AG: Start of the Phase II clinical trial with Elafin

  
    
  
  
    
      Proteo Inc. (OTCBB: PTEO; WKN: 925981) and its wholly-owned subsidiary 
      Proteo Biotech AG announced today the beginning of patient recruitment 
      for a Phase II clinical trial. In this randomized, placebo-controlled 
      Phase II trial the effect of Elafin on inflammatory parameters will be 
      investigated in patients undergoing esophagectomy for esophagus 
      carcinoma. The trial will be performed under the direction of Prof. Fred 
      Fändrich, Department of General and Thoracic Surgery, University of 
      Kiel: »The removal of the esophagus for esophageal cancer is a very 
      invasive surgical procedure that frequently requires long stays in 
      intensive care units. No drugs are currently available which 
      substantially alleviate the inflammatory reaction of the body to this 
      surgical treatment. I am therefore particularly pleased that we have the 
      opportunity to conduct the first clinical trial worldwide on the 
      therapeutic efficacy of the drug candidate Elafin.«
    
    
      »As the second largest university hospital in Germany, the University 
      Hospital of Schleswig-Holstein offers an ideal infrastructure for 
      performing a trial of this type. We are confident that the results of 
      the trial will provide confirmation of the mode of action (proof of 
      concept) and so promote our multifaceted development program for 
      Elafin,« announced Birge Bargmann, CEO of Proteo.
    
    
      Prof. Oliver Wiedow, who discovered Elafin and founded Proteo, draws a 
      positive balance: »With the start of this trial we are also setting a 
      new milestone for biotechnology in Kiel. The close cooperation of many 
      committed colleagues at the University Hospital, the state's economic 
      development fund and Proteo Biotech AG, has made it possible to promote 
      in Schleswig-Holstein the development of a pharmaceutical, that was 
      discovered in the Department of Dermatology at the University of Kiel, 
      and to make this drug substance available for the first time to patients 
      within the framework of a clinical trial.«
    
    
      About Elafin
    
    
      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.
    
    
      About Proteo
    
    
      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).
    
    
      Forward-Looking Statements
    
    
      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.