LEUVEN, Belgium and LUND, Sweden, February 12 /PRNewswire/ -- ThromboGenics NV and BioInvent International AB (OMXS:BINV) announced today that they have received approval from the Danish Medicines Agency to initiate a Phase I clinical trial of the novel anticoagulant, TB-402. TB-402 is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood. The project is being developed within the framework of the alliance between ThromboGenics and BioInvent.
The study is a randomised, placebo-controlled, dose escalation trial in healthy volunteers, and the objective is to investigate safety, tolerability and pharmacokinetic properties of the candidate drug. It is expected that the first subjects will be recruited in the study soon, and that the results will be presented in late 2007. Given a positive outcome of the initial Phase I study, the parties plan to follow up with a Phase IIa programme in patients undergoing orthopaedic surgery who are at risk for thrombosis. TB-402 is also expected to be developed as a potential treatment to prevent blood clot formation in connection with certain types of heart arrhythmia, such as atrial fibrillation.
Professor Desire Collen, CEO and Chairman of ThromboGenics, commented: "The entry of TB-402 into formal clinical development is an important milestone for ThromboGenics and our partner BioInvent. We are both excited about the potential of this novel anti-coagulant, which acts via binding to Factor VIII, to prevent thrombosis in a number important disease settings."
"We are very pleased with the progress of this collaboration with ThromboGenics, which has now reached the point when the first product is entering clinical trials," added Svein Mathisen, Chief Executive Officer of BioInvent.
TB-402 is a human antibody binding to Factor VIII, which plays a crucial role in the coagulation of the blood. The antibody has shown a beneficial partial inhibition of Factor VIII, even when applied in excess dosage. Extensive testing in several animal models has shown that TB-402 strongly reduces the risk of thrombosis without increasing the risk of bleeding.
The collaboration for development of TB-402 is carried out within the existing alliance between ThromboGenics and BioInvent, originally initiated in September 2004. Another joint programme focuses on the development of TB-403 (anti-PlGF) as a novel anti-angiogenesis therapy for treatment of tumours, inflammation and eye disease. In December 2006, ThromboGenics and BioInvent were awarded a Euro 2 Million EU Grant to support this programme.
For more information ThromboGenics NV Citigate Dewe Rogerson Professor Desire Collen David Dible, Valerie Auffray Chief Executive Officer Tel: +44-(0)207-638-9571 Tel : +32-(0)-16-34-61-94 Valerie.auffray@citigatedr.co.uk Stuart Laermer Chief Business Officer ThromboGenics Inc. Tel: +1-(212)-201-0920 BioInvent International AB Svein Mathisen Cristina Glad President & CEO Executive Vice President Tel: +46-(0)46-286-85-67 Tel: +46-(0)46-286-85-51 Mobile: +46-(0)708-97-82-13 Mobile: +46-(0)708-16-85-70 E-mail: svein.mathisen@bioinvent.com E-mail: cristina.glad@bioinvent.com Legal disclaimer
This press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as of the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.
Notes to editors:
ThromboGenics NV is a biotechnology company focused on discovery and development of biopharmaceuÂÂticals 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 also has five other drug candidates in preclinical development with preclinical proof-of-principle demonstrated, including TB-402 (Anti-Factor VIII) and TB-403 (Anti-PlGF). The Company has built strong links with the University of Leuven and has exclusive rights to certain therapeutics developed at the University. ThromboGenics is headÂÂquartered in Leuven, Belgium and has subsidiaries in Ireland and the U.S. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at 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, HIV infection
and ophthalmic diseases. The Company recently announced a major strategic alliance with American-based Genentech in the cardiovascular field.
These projects are based on a competitive technology platform that covers the value chain for
development of new drugs. The scope and strength of this platform is also utilised by partners, such
as ALK-Abello, ImmunoGen, OrbusNeich, Syngenta, UCB and XOMA.
The Company, which currently has 96 employees, is located at Ideon in Lund. ThromboGenics NV BioInvent International AB (publ) Campus Gasthuisberg Co. reg. No. 556537-7263, Herestraat 49 Address: Solvegatan 41 B-3000 Leuven Mailing address: SE-223 70 LUND Belgium Tel: +46-(0)46-286-85-50 Tel: +32-(0)-16-34-61-94 info@bioinvent.comwww.thrombogenics.comwww.bioinvent.com
ThromboGenics NVCONTACT: ThromboGenics NV, Professor Desire Collen, Chief ExecutiveOfficer, Tel : +32-(0)-16-34-61-94, Stuart Laermer, Chief Business Officer,ThromboGenics Inc., Tel: +1-(212)-201-0920, Citigate Dewe Rogerson, DavidDible, Valerie Auffray, Tel: +44-(0)207-638-9571,Valerie.auffray@citigatedr.co.uk, BioInvent International AB, SveinMathisen, President & CEO, Tel: +46-(0)46-286-85-67, Mobile:+46-(0)708-97-82-13, E-mail: svein.mathisen@bioinvent.com, Cristina Glad,Executive Vice President, Tel: +46-(0)46-286-85-51, Mobile:+46-(0)708-16-85-70, E-mail: cristina.glad@bioinvent.com
