ThromboGenics and BioInvent Complete Patient Recruitment of Phase II DVT Prophylaxis Study With Anti-Factor VIII (TB-402)
LEUVEN,
– 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
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.”
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
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,
Euronext Brussels under the symbol THR. More information is available at
www.thrombogenics.com.
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 www.bioinvent.com.
———————————
[1] Barclays Capital Equity Research Report on New Anticoagulants,
5, 2009
[2] “The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis
and Pulmonary Embolism,”
[3] “Changes in Surgical Loads and Economic Burden of Hip and Knee
Replacements in the US: 1997-2004,”
(Arthritis Care & Research),
For further information, please contact:
ThromboGenics NV
Patrik De Haes, MD
Chief Executive Officer
Tel : +32-(0)-16-75-13-10
E-mail: patrik.dehaes@thrombogenics.com
Andy De Deene, MD
Clinical Director Europe
Tel: +32-(0)-16-75-13-10
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
BioInvent International AB
Svein Mathisen
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
College Hill (media enquiries)
Holly Griffiths, Sue Charles, John McIntyre
Tel: +44-(0)20-7866-7856
E-mail: bioinvent@collegehill.com
ThromboGenics NV
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Tel: +32-(0)16-75-13-10
http://www.thrombogenics.com
BioInvent International AB
(publ)
Co. reg. No. 556537-7263,
Address: Solvegatan 41
Mailing address: SE-223 70 LUND
Tel: +46-(0)46-286-85-50
info@bioinvent.com
http://www.bioinvent.com
SOURCE ThromboGenics NV