Proteo, Inc. (OTCBB: PTEO; WKN: 925981) and its wholly-owned subsidiary Proteo Biotech AG announced today the successful completion of patient recruitment for the Phase II clinical trial on the intravenously administered study drug Elafin. In this blinded, randomized, controlled Phase II clinical trial the effect of Elafin on the postoperative inflammatory reaction is being investigated in patients undergoing esophagectomy for esophagus carcinoma. The trial is being conducted at 3 German university hospitals - Kiel, TU-Munich and Muenster. Birge Bargmann, CEO of Proteo: "We expect to have preliminary data on the efficacy of our elastase inhibitor in the near future and we are optimistic that the results of the trial will meet our expectations."

In January of this year, on recommendation of the European Medicines Agency EMEA, Orphan Drug Status was awarded to Proteo by the European Commission for the use of Elafin in the treatment of esophagus carcinoma. Classification as an orphan drug allows an accelerated approval procedure in all EU states. After presentation of the trial results Proteo will consult the European Medicines Agency EMEA, which is responsible for the centralized European approval procedure, for scientific advice regarding the requirements for a further trial which is planned at the end of 2010.

Further information on the clinical development program for Elafin:

Proteo's drug substance Elafin is a natural human antagonist of elastase and proteinase-3, two potent tissue destroying enzymes, both of which participate in the inflammatory mechanism of a variety of diseases. Elafin's ability to block these inflammation promoting enzymes makes it a promising drug candidate for the treatment of inflammatory lung diseases and severe reperfusion injury. The excellent tolerability of intravenously administered recombinant Elafin was demonstrated convincingly in a Phase I clinical trial. In addition to the above mentioned trial on esophagus carcinoma, Proteo's licensing and development partner, Minapharm Pharmaceuticals SAE, has initiated a further Phase II clinical trial on the use of Elafin in kidney transplantation patients. This trial is concerned with the prevention of acute organ rejection and chronic graft injury (allograft nephropathy) and will be conducted at the University of Cairo. As a further cooperation partner, the University of Edinburgh is planning a clinical trial to test Elafin in the context of bypass surgery after a heart attack.

Source
Proteo