BioInvent and ThromboGenics Start Recruitment of Second 100 Patient Cohort
in Phase II DVT Prophylaxis Study with TB-402
Lund, Sweden and Leuven, Belgium – 3 July 2009 - BioInvent
International AB (OMXS: BINV) and ThromboGenics NV (Euronext Brussels: THR)
announce that they have started recruitment of a second cohort of patients for
their Phase II trial of TB-402. This follows completion of recruitment of the
first cohort of 100 patients 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 decision to move ahead
with the second cohort of this trial follows unanimous advice from the
external efficacy and safety monitoring board to proceed using a higher dose
of TB-402.
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 given as a single intravenous bolus injection post
knee replacement surgery and will enrol a total of 300 patients across 36
centers in Europe. The objective of the study is to assess the safety and
efficacy of the three escalating doses of TB-402.
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 anticoagulants. In addition, TB-402 is a
long-acting agent, which means it could be given as a single dose after
surgery to prevent the development of DVT. This would be an attractive option,
as all current anticoagulant treatment options require daily treatment for up
to several weeks.
Professor Peter Verhamme from the University of Leuven will present additional
data from the earlier successful Phase I study at the XXII Congress of the
International Society on Thrombosis and Haemostasis (ISTH) on 15 July, 2009,
in Boston.
Svein Mathisen, CEO of BioInvent, commented, “We are pleased that there has
been rapid progress in this study and that the efficacy and safety monitoring
board unanimously recommended that we proceed to a higher dose of TB-402. It
is testament to the strength of our partnership with ThromboGenics and the
exciting potential of this product candidate.”
Patrik De Haes, CEO of ThromboGenics, also commented, “We are very happy that
this important study with TB-402 is progressing rapidly. TB-402’s profile,
including its novel mode of action, could allow it to address the many
drawbacks associated with current anticoagulant therapy. We remain confident
in the large market potential for TB-402, and believe that the current Phase
II study will provide additional data to further highlight the attractive
differentiating properties of this novel long-acting anticoagulant.”
-- END --
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 US alone, more than 350,000 individuals are affected by
DVT or pulmonary embolism (PE) each year. Moreover, DVT and PE together may be
responsible for more than 100,000 deaths in the U.S. each year.[1]
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.[2] 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.
For further information, please contact:
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
College Hill (media enquiries)
Holly Griffiths, Sue Charles and John McIntyre
Tel: +44 (0)20 7457 2020
E-mail: bioinvent@collegehill.com
ThromboGenics NV
Patrik De Haes MD Andy De Deene MD
Chief Executive Officer Clinical Director Europe
Tel : +32 (0) 16 75 13 10 Tel: +32 (0) 16 75 13 10
E-mail: patrik.dehaes@thrombogenics.com
E-mail: andy.dedeene@thrombogenics.com
Citigate Dewe Rogerson
Amber Bielecka, David Dible, Nina Enegren
Tel: +44 (0) 207 638 95 71
E-mail:
amber.bielecka@citigatedr.co.uk
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 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-Abelló, Bayer HealthCare, ImmunoGen,
OrbusNeich, Sanofi-Aventis, UCB and XOMA. More information is available at
www.bioinvent.com.
About ThromboGenics
ThromboGenics is a biotechnology company focused on the discovery and
development of innovative biopharmaceuticals 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 indications and as a potential
therapy for stroke. ThromboGenics is also developing novel antibody
therapeutics in collaboration with BioInvent International; these include
TB-402 (Anti-Factor VIII), a long acting anticoagulant, 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
www.thrombogenics.com.
BioInvent International AB (publ)
ThromboGenics NV
Co. reg. No. 556537-7263,
Gaston Geenslaan 1
Address: Sölvegatan 41
B-3001 Leuven
Mailing address: SE-223 70 LUND
Belgium
Tel: +46 (0)46 286 85 50
Tel: +32 (0) 16 75 13 10
www.bioinvent.com
www.thrombogenics.com
Information disclosed in this press release is provided herein pursuant to the
Swedish Securities Markets Act and/or the Swedish Financial Instruments
Trading Act. The information was submitted for publication at 7.30 a.m. CET,
on 3 July, 2009.
