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ThromboGenics and BioInvent Complete Patient Recruitment of Phase II DVT Prophylaxis Study With Anti-Factor VIII (TB-402)

LEUVEN, Belgium and LUND, Sweden, October 28 /PRNewswire-FirstCall/ --

- Recruitment of 315 Patients Completed Ahead of Schedule - Results Anticipated in the second quarter of 2010

ThromboGenics NV (Euronext Brussels: THR) and co-development partner BioInvent International (OMXS: BINV) announce that they have completed recruitment of their Phase II trial of TB-402 ahead of schedule. TB-402 is a novel, long acting anticoagulant that is being developed for the prevention of deep vein thrombosis (DVT) following orthopaedic surgery. The results of this study, which has recruited 315 patients, are anticipated in the second quarter of 2010.

TB-402 has the potential to be a very important new entrant into the anticoagulant market. TB-402 is a recombinant human monoclonal antibody that partially inhibits Factor VIII, a key component of the coagulation cascade. This novel mode of action is expected to reduce the risk of undesirable bleeding events, even at high doses, as well as the need for patient monitoring. These are the two main drawbacks associated with current anticoagulant therapy. In addition, TB-402 is a long-acting agent, which means it could be given as a single dose to prevent the development of DVT in patients undergoing surgery. This would be an attractive option, as all current anticoagulant treatment options require daily treatment for up to several weeks.

The Phase II trial is an active (enoxaparin)-controlled, dose-escalating, multicenter, prospective, randomised, open label trial evaluating TB-402 for the prophylaxis of DVT after knee surgery. The study is assessing three different doses of TB-402 (0.3, 0.6 and 1.2 mg/kg) each given as a single intravenous bolus injection post knee replacement surgery. The objective of the study is to assess the safety and efficacy of the three escalating doses of TB-402. The study enrolled a total of 315 patients across 30 centers, mainly in Europe.

Patrik De Haes, CEO of ThromboGenics, commented, "We are very pleased to announce the completion of enrolment ahead of schedule for TB-402. We believe that based on its novel profile, TB-402 could be an important new entrant into the anticoagulant therapy market. Given the size of commercial opportunity for TB-402 and the sales reach that will be needed to engage with all of the potential prescribers of TB-402, it is our intention to seek a partner to undertake the later stage development and commercialisation of this exciting new agent. We very much look forward to announcing the results from this study in Q2 next year."

Svein Mathisen, CEO of BioInvent, also commented, "At BioInvent, we are proud to have maintained excellent momentum in the Phase II study of TB-402, which is on track to be completed ahead of schedule. We look forward to announcing the results of the study in Q2 next year. Our expectation is that the ongoing clinical development will underpin the product profile as a safe and effective long acting new anticoagulant."

About Deep Vein Thrombosis (DVT)

DVT is caused when a blood clot forms in a deep vein, most commonly in the deep veins of the lower leg. DVT is a major public health issue and it is estimated that in the U.S. alone, more than 600,000 patients are treated for venous thromboembolisms such as DVT or pulmonary embolism (PE) each year.[1] Moreover, DVT and PE together may be responsible for more than 100,000 deaths in the U.S. each year.[2]

It is estimated that by 2015, 1.4 million patients will undergo knee replacement and 600,000 patients will undergo hip replacement in the U.S. if current trends persist.[3] Patients undergoing hip replacement or knee surgery are particularly at risk of developing DVT and all patients are therefore treated with anticoagulants prophylactically in order to reduce the risks of blood clots. The annual sales of anticoagulants worldwide are over $5 billion. Nevertheless, available anticoagulants are still inconvenient and associated with an increased risk of bleeding. Improved anticoagulants are therefore required. In particular, agents that allow for improved ease of administration (without requirement for daily dosing and frequent dose adjustment) would fill a significant unmet need.

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:

About ThromboGenics

ThromboGenics is a biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of eye disease, vascular disease and cancer. The Company's lead product microplasmin is in Phase III clinical development for the non-surgical treatment of back of the eye diseases. Microplasmin is also being evaluated in Phase II clinical development for additional vitreoretinal conditions. In addition, ThromboGenics is developing novel antibody therapeutics in collaboration with BioInvent International; these include TB-402 (Anti-Factor VIII), a long acting anti-coagulant, and TB-403 (anti-PlGF) for cancer.

ThromboGenics has built strong links with the University of Leuven and the Flanders Institute for Biotechnology (VIB) and has exclusive rights to certain therapeutics developed at these institutions. ThromboGenics is headquartered in Leuven, Belgium. The Company is listed on Eurolist by Euronext Brussels under the symbol THR. More information is available at

About BioInvent

BioInvent International AB, listed on the NASDAQ OMX Stockholm (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 and atherosclerosis. The Company has signed various strategic alliances around these product candidates and is developing them in collaboration with partners including Genentech, Roche and ThromboGenics.

These projects are based around a competitive and in substance patented antibody development platform. The scope and strength of this platform is also utilised by partners, such as ALK-Abello, Bayer HealthCare, ImmunoGen, Mitsubishi Tanabe Pharma Corporation, OrbusNeich, UCB and XOMA. More information is available at


[1] Barclays Capital Equity Research Report on New Anticoagulants, August 5, 2009

[2] "The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism," September 15, 2008, p.1.

[3] "Changes in Surgical Loads and Economic Burden of Hip and Knee Replacements in the US: 1997-2004," Sunny Kim, Arthritis & Rheumatism (Arthritis Care & Research), April 15, 2008; 59:4, pp. 481-488.

    For further information, please contact:

    ThromboGenics NV
    Patrik De Haes, MD
    Chief Executive Officer
    Tel : +32-(0)-16-75-13-10

    Andy De Deene, MD
    Clinical Director Europe
    Tel: +32-(0)-16-75-13-10

    Citigate Dewe Rogerson
    Amber Bielecka, David Dible, Nina Enegren
    Tel: +44-(0)-207-638-95-71

    BioInvent International AB
    Svein Mathisen
    President & CEO
    Tel: +46-(0)46-286-85-67
    Mobile: +46-(0)708-97-82-13

    Cristina Glad
    Executive Vice President
    Tel: +46-(0)46-286-85-51
    Mobile: +46-(0)708-16 85-70

    College Hill (media enquiries)
    Holly Griffiths, Sue Charles, John McIntyre
    Tel: +44-(0)20-7866-7856

    ThromboGenics NV
    Gaston Geenslaan 1
    B-3001 Leuven
    Tel: +32-(0)16-75-13-10

    BioInvent International AB
    Co. reg. No. 556537-7263,
    Address: Solvegatan 41
    Mailing address: SE-223 70 LUND
    Tel: +46-(0)46-286-85-50

SOURCE ThromboGenics NV

SOURCE ThromboGenics NV
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