Date: 2011-08-29
Type of information:
phase: 1b
Announcement: initiation
Company: Paion (Germany)
Product: Solulin (recombinant human thrombomodulin)
Action mechanism: Solulin is an improved variant of the human protein thrombomodulin, an important natural regulator of the clotting system. One of the functions of thrombomodulin is to stabilize the initial fibrin clot to stop bleeding. Other than native thrombomodulin which is anchored in the wall of blood vessels, Solulin can enter the blood stream to reach its potential site of action. In low concentrations Solulin is able to stabilise blood clots and to support coagulation.
Disease: hemophilia A
Therapeutic area: Hematological diseases - Genetic diseases - Rare diseases
Country:
Trial details: This Phase Ib study is an open label, randomized, multicenter, dose finding study evaluating the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Solulin in patients with severe haemophilia A receiving chronic therapy with coagulation factor VIII. First results of the study are expected in 2012.
Latest news: Paion has announced the start of a Phase Ib study with its recombinant human thrombomodulin Solulin in the indication of hemophilia.
