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.
In the blinded, randomised, 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, said: “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.”
Earlier, 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 is expected to consult the European Medicines Agency EMEA, for scientific advice regarding the requirements for a further trial which is planned at the end of 2010.