LEUVEN, Belgium and LUND, Sweden, January 18 /PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International AB (Nordic Exchange: BINV) announce today that they have received approval from the regulatory authorities in Denmark to initiate a Phase I clinical trial of the novel anti-cancer agent TB-403. 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. This product candidate is being developed within the framework of the alliance between ThromboGenics and BioInvent.
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 randomised 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.
Prof. Desire Collen, CEO and Chairman of ThromboGenics, commenting on today's announcement, said: "I am very pleased with the progress made with TB-403. Seeing this novel monoclonal antibody enter the clinic is an important milestone for us and our partner BioInvent. Preclinical data has shown that TB-403 has a unique mode action, blocking the formation of new blood vessels in the cancer tumour without affecting healthy tissues."
Svein Mathisen, CEO of BioInvent, added: "We are pleased that we and our partner ThromboGenics have taken this innovative anti-cancer agent to the clinical stage. TB-403 could be a novel treatment of cancer. There is a clear medical need for an effective and safe new anti-angiogenic treatment of cancer. 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."
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.
Angiogenesis inhibitors such as TB-403 are therapeutic agents that work by blocking the development of new blood vessels, thereby depriving growing cancer tumour cells of oxygen and nutriments. This approach in turn is thought to stop the tumour from growing and spreading to other parts of the body. Currently available angiogenesis inhibitors specifically target vascular endothelial growth factor (VEGF), which plays an important role in promoting 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 process which takes place in the diseased tissue. Therefore, as an inhibitor of PlGF, TB-403 is likely to inhibit tumour growth without the side effects associated with other anti-angiogenic therapies.
Extensive research in this area was recently published as the featured article in the journal Cell ("Anti-PlGF Inhibits Growth of VEGF(R)-Inhibitor-Resistant Tumors Without Affecting Healthy Vessels," Carmeliet, Fischer, et al, Cell 131, 463-475, November 2, 2007).
ThromboGenics is a biotechnology company focused on discovery and development of biopharmaceuticals for the treatment of a range of vascular diseases. The Company has several programs in Phase II clinical development including microplasmin, which is being evaluated as a treatment for vitreoretinal disorders and as a thrombolytic agent for vascular occlusive diseases, including acute stroke. ThromboGenics is also developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), scheduled to enter Phase II clinical development in 2008, and TB-403 (Anti-PlGF), which has received approval to begin Phase I clinical trials for the treatment of cancer. ThromboGenics has built strong links with the University of Leuven and has exclusive rights to certain therapeutics developed at the University. ThromboGenics is headquartered in Leuven, Belgium and has subsidiaries in Dublin, Ireland and New York, U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at http://www.thrombogenics.com.
BioInvent International AB, listed on The Nordic Exchange (OMXS:BINV), is a research-based pharmaceutical company that focuses on developing antibody drugs. The Company is currently running innovative drug projects within the areas of thrombosis, cancer, atherosclerosis and ophthalmic diseases. In January 2007 the Company announced a major strategic alliance with American-based Genentech, Inc. in the cardiovascular field. These projects are based on a competitive and in substance patented technology platform. The scope and strength of this platform is also utilised by partners, such as ALK-Abello, ImmunoGen, OrbusNeich, Sanofi-Aventis, UCB and XOMA.
The Company, which currently has 96 employees, is located at Ideon in Lund.
Important information about forward-looking statements
Certain statements in this press release may be considered "forward-looking". Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the prospectus.
SOURCE ThromboGenics NV