Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.ThromboGenics and co-development partner BioInvent International have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of the novel anti-cancer agent TB-403.
Subscribe to our email newsletter
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.
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. 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.
Svein Mathisen, CEO of BioInvent, said: “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.”