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news.ThromboGenics and co-development partner BioInvent International have reported that the results from the first Phase I 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.
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The companies have 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.
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.
TB-403 is a monoclonal antibody that targets the angiogenic factor placental growth factor.
Desire Collen, CEO and chairman of ThromboGenics, said: “This is an important milestone for ThromboGenics and our partner BioInvent. This study reinforces our belief that TB-403 has the potential to become a significant treatment for cancer due to TB-403’s unique mode of action.”