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news.Proteo, a developer of pharmaceutical products, and its wholly owned subsidiary Proteo Biotech together with Minapharm Pharmaceuticals, a prescription medicine company, and its subsidiary Rhein Minapharm Biogenetics, have obtained Egyptian approval for a Phase II clinical trial to study the efficacy of Elafin on kidney transplant patients.
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The study will be conducted as a randomized, double-blinded, placebo-controlled Phase II trial for prevention of acute and chronic allograft nephropathy at the University of Cairo. The aim of the trial is to investigate the effectiveness of Elafin at suppressing the inflammatory processes that frequently occur after transplantation and contribute to organ rejection and accelerated aging of the transplanted organ.
A further Phase II clinical trial on patients undergoing esophagectomy for esophagus carcinoma has already been started in the clinic for general and thorax surgery at the University Hospital of Schleswig-Holstein, Campus Kiel.
In 2007, Proteo and Minapharm have entered into a licensing agreement for the clinical development, production and marketing of Elafin in Egypt, Middle Eastern and African countries. Proteo will receive an upfront payment, milestone-payments and royalties on net product sales. In addition, Minapharm will take over the funding of clinical research activities for the designated region.