ThromboGenics and BioInvent Receive Approval to Begin Clinical Trials of TB-403 for the Treatment... ( LEUVEN Belgium and LUND Sweden Ja...)

ThromboGenics and BioInvent Receive Approval to Begin Clinical Trials of TB-403 for the Treatment of Cancer

Date:1/18/2008

LEUVEN, Belgium and LUND, Sweden, January 18 /PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International AB (Nordic Exchange: BINV) announce today that they have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of the novel anti-cancer agent TB-403. TB-403 is a monoclonal antibody that targets the angiogenic factor PlGF (placental growth factor). TB-403 has demonstrated strong inhibition of PlGF-associated angiogenesis and tumour growth in animal models, without affecting healthy tissues. This product candidate is being developed within the framework of the alliance between ThromboGenics and BioInvent.

The first Phase I clinical study will be performed in Denmark, with the first subject expected to be recruited in the study soon. The trial is a double-blind and within-group randomised trial 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 2008. The trial 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.

Prof. Desire Collen, CEO and Chairman of ThromboGenics, commenting on today's announcement, said: "I am very pleased with the progress made with TB-403. Seeing this novel monoclonal antibody enter the clinic is an important milestone for us and our partner BioInvent. Preclinical data has shown that TB-403 has a unique mode action, blocking the formation of new blood vessels in the cancer tumour without affecting
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ThromboGenics and BioInvent Receive Approval to Begin Clinical Trials of TB-403 for the Treatment...( LEUVEN Belgium and LUND Sweden Ja...)