|
Approval also received to start second repeat-dose Phase I study in patients with advanced cancer
Lund, Sweden and Leuven, Belgium | June 3, 2008 | BioInvent International AB (OMX Nordic Exchange Stockholm: BINV) and co-development partner ThromboGenics NV (Euronext Brussels: THR) today 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 tumours.
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, randomised 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 BioInvent and ThromboGenics 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 tumours 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.
Svein Mathisen, CEO of BioInvent, commenting on today´s announcement, said: "We are pleased at the continued progress seen in our collaboration with ThromboGenics and at the success of this product in Phase I. Based on these data, we look forward to embarking imminently on the planned second Phase I study in patients with advanced cancer, while we continue to prepare for future development and commercialisation."
Professor Désiré Collen, CEO and Chairman of ThromboGenics, added: "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. TB-403 blocks the formation of new blood vessels in the cancer tumour without affecting healthy tissues. We are delighted that the vision we shared with BioInvent is progressing and with today´s news, is becoming more tangible."
SOURCE: BioInvent International |
