ThromboGenics NV and co-development partner BioInvent International AB have reported that the results from the first Phase l study of novel anti-cancer agent TB-403 showed that it is safe and well tolerated, with pharmacokinetic properties enabling it to be developed for the treatment of cancer.
The companies also announced that they have received approval from the regulatory authorities in Denmark to initiate a second repeat-dose Phase I clinical trial of TB-403 in patients with advanced solid tumors.
TB-403 is a monoclonal antibody that targets the angiogenic factor PlGF (placental growth factor). The product has demonstrated inhibition of PlGF-associated angiogenesis and tumour growth in animal models, without affecting healthy tissues. The completed Phase I study was a double-blind, randomized trial testing a single-dose of TB-403 at three escalating levels or placebo in 16 healthy male subjects.
The results of the trial have shown that TB-403 met both primary endpoints regarding safety and tolerability, and secondary endpoints examining pharmacokinetics. These results have provided the basis for a safe and efficient introduction of the compound into a subsequent repeat-dose trial in patients for which ThromboGenics and BioInvent have now received approval.
The second Phase I trial will be a study of tolerability, pharmacokinetics and pharmacodynamics in patients with advanced cancer. Up to 30 patients with metastatic or unresectable solid tumors will be enrolled in this open, dose escalation multi-dose study. The study will take place in Denmark and patient recruitment is due to begin shortly.