The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomized, open-label trial evaluating TB-402 for the prophylaxis of deep vein thrombosis (DVT) after knee surgery. The study will assess three different doses of TB-402 given as a single intravenous bolus injection post knee replacement surgery.
The trial will enroll 300 patients across 36 centers mainly in central Europe. The primary endpoint is the safety and efficacy of the three escalating doses of TB-402. It is anticipated that the study will conclude by the end of 2010.
Svein Mathisen, CEO of BioInvent, said: The initiation of this Phase II trial is another successful step forward in the clinical development of our antibody product development portfolio. TB-402 addresses a broad market and has potentially significant advantages over existing anticoagulants. We are hopeful it will have application in a number of clinical settings.
ThromboGenics is a biotechnology company focused on the discovery and development of biopharmaceuticals for the treatment of eye disease, vascular disease and cancer. The
company’s lead product Microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases.
BioInvent, is a research-based pharmaceutical company that focuses on developing antibody drugs. The company is currently running innovative drug projects within the areas of thrombosis, cancer and atherosclerosis.