Thrombogenics/BioInvent OKed to start TB-403 trial

Leuven, Belgium-based ThromboGenics and co-development partner BioInvent International AB of Sweden have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of the novel anticancer agent TB-403. This is a monoclonal antibody that targets the angiogenic factor PlGF (placental growth factor). It has demonstrated strong inhibition of PlGF-associated angiogenesis and tumor growth in animal models, without affecting healthy tissues.

The first Phase I study will be performed in Denmark, with the first subject expected to be recruited soon. The trial is a double-blind and within-group randomized assessment testing single-doses of TB-403 or placebo at three escalating levels in 16 healthy male subjects. The objective is to monitor tolerability and safety after three single escalating intravenous doses. Furthermore, pharmacokinetics will be determined with the objective to create the basis for a safe and efficient introduction of the compound in the subsequent repeat-dose trial.

The repeat-dose trial is expected to start during the third quarter of 2008. It will be a study of tolerability, pharmacokinetics and pharmacodynamics in patients with advanced cancer. Cohorts of patients having failed prior therapy will be given escalating doses, the firms said.