BioInvent, ThromboGenics Initiate Patients Enrollment For Deep Vein Thrombosis

Published: 03-Jul-2009

Study to assess safety and efficacy of three escalating doses of TB-402

BioInvent and ThromboGenics have initiated the enrollment of second cohort of patients for their phase-II trial of TB-402. TB-402 is a novel, long acting anticoagulant for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery.

The phase-II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomised, open label trial, evaluating TB-402 for the prophylaxis of DVT after knee surgery.

The company said that the study is assessing three different doses of TB-402 given as a single intravenous bolus injection, post knee replacement surgery. It will enroll a total of 300 patients across 36 centers in Europe. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402.

Patrik De Haes, CEO of ThromboGenics, said: “We are very happy that this important study with TB-402 is progressing rapidly. TB-402's profile, including its novel mode of action, could allow it to address the many drawbacks associated with current anticoagulant therapy. We remain confident in the large market potential for TB-402, and believe that the current Phase II study will provide additional data to further highlight the attractive differentiating properties of this novel long-acting anticoagulant.”

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