ThromboGenics, BioInvent To Begin Clinical Trials Of For Cancer Treatment

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ThromboGenics NV, BioInvent International AB 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.

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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 healthy tissues."

Svein Mathisen, CEO of BioInvent, added: "We are pleased that we and our partner ThromboGenics have taken this innovative anti-cancer agent to the clinical stage. TB-403 could be a novel treatment of cancer. There is a clear medical need for an effective and safe new anti-angiogenic treatment of cancer. TB-403 does not induce an angiogenic switch and resistance to the drug, has potentially less side effects and may therefore be well suited for long term treatment."

ThromboGenics and BioInvent also intend to develop TB-403 for eye diseases, to block uncontrolled blood vessel growth in conditions such as age-related macular degeneration (AMD) and diabetic retinopathy.

Angiogenesis inhibitors such as TB-403 are therapeutic agents that work by blocking the development of new blood vessels, thereby depriving growing cancer tumour cells of oxygen and nutriments. This approach in turn is thought to stop the tumour from growing and spreading to other parts of the body. Currently available angiogenesis inhibitors specifically target vascular endothelial growth factor (VEGF), which plays an important role in promoting the formation of blood vessels. PlGF is a homologue of VEGF but,unlike other angiogenesis factors such as VEGF, it does not affect normal, physiological angiogenesis and is only involved in the angiogenesis process which takes place in the diseased tissue. Therefore, as an inhibitor of PlGF, TB-403 is likely to inhibit tumour growth without the side effects associated with other anti-angiogenic therapies.

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