BioInvent International AB and co-development partner ThromboGenics NV have announced 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 tumor 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 randomized 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.
Svein Mathisen, CEO of BioInvent, commenting on today’s announcement, said: “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.”
Professor Désiré Collen, CEO and Chairman of ThromboGenics, added: ”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.”
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.