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The first Phase I clinical study will be performed in Denmark, with thefirst subject expected to be recruited in the study soon. The trial is adouble-blind and within-group randomised trial testing single-doses of TB-403or placebo at three escalating levels in 16 healthy male subjects. Theobjective is to monitor tolerability and safety after three single escalatingintravenous doses. Furthermore, pharmacokinetics will be determined with theobjective to create the basis for a safe and efficient introduction of thecompound in the subsequent repeat-dose trial.
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The repeat-dose trial is expected to start during the third quarter 2008.The trial will be a study of tolerability, pharmacokinetics andpharmacodynamics in patients with advanced cancer. Cohorts of patients havingfailed prior therapy will be given escalating doses.
Prof. Desire Collen, CEO and Chairman of ThromboGenics, commenting ontoday's announcement, said: "I am very pleased with the progress made withTB-403. Seeing this novel monoclonal antibody enter the clinic is animportant milestone for us and our partner BioInvent. Preclinical data hasshown that TB-403 has a unique mode action, blocking the formation of newblood vessels in the cancer tumour without affecting healthy tissues."
Svein Mathisen, CEO of BioInvent, added: "We are pleased that we and ourpartner ThromboGenics have taken this innovative anti-cancer agent to theclinical stage. TB-403 could be a novel treatment of cancer. There is a clearmedical need for an effective and safe new anti-angiogenic treatment ofcancer. TB-403 does not induce an angiogenic switch and resistance to thedrug, has potentially less side effects and may therefore be well suited forlong term treatment."
ThromboGenics and BioInvent also intend to develop TB-403 for eyediseases, to block uncontrolled blood vessel growth in conditions such asage-related macular degeneration (AMD) and diabetic retinopathy.
Angiogenesis inhibitors such as TB-403 are therapeutic agents that workby blocking the development of new blood vessels, thereby depriving growingcancer tumour cells of oxygen and nutriments. This approach in turn isthought to stop the tumour from growing and spreading to other parts of thebody. Currently available angiogenesis inhibitors specifically targetvascular endothelial growth factor (VEGF), which plays an important role inpromoting the formation of blood vessels. PlGF is a homologue of VEGF but,unlike other angiogenesis factors such as VEGF, it does not affect normal,physiological angiogenesis and is only involved in the angiogenesis processwhich takes place in the diseased tissue. Therefore, as an inhibitor of PlGF,TB-403 is likely to inhibit tumour growth without the side effects associatedwith other anti-angiogenic therapies.
Extensive research in this area was recently published as the featuredarticle in the journal Cell ("Anti-PlGF Inhibits Growth ofVEGF(R)-Inhibitor-Resistant Tumors Without Affecting Healthy Vessels,"Carmeliet, Fischer, et al, Cell 131, 463-475, November 2, 2007).
About ThromboGenics
ThromboGenics is a biotechnology company focused on discovery anddevelopment of biopharmaceuticals for the treatment of a
