Quantcast
Last updated on April 19, 2014 at 18:42 EDT

ThromboGenics and BioInvent Start Phase II Trial of TB-402, a Novel, Long Acting Anticoagulant for Deep Vein Thrombosis (DVT) Prophylaxis

February 23, 2009

LEUVEN, Belgium and LUND, Sweden, February 23 /PRNewswire-FirstCall/ –

– Trial to Assess the Benefits of Partial Factor VIII Inhibition in
Patients Undergoing Knee Replacement Surgery

ThromboGenics NV (Euronext Brussels: THR) and co-development partner
BioInvent International (OMXS: BINV) announce today that the first patient
has been enrolled in the Phase II trial with their long-acting anticoagulant
TB-402 for the prophylaxis of Deep Vein Thrombosis (DVT) following
orthopaedic surgery. TB-402, which is given as a single injection post
surgery, could overcome the major drawbacks such as bleeding and the need for
extensive patient monitoring associated with current anti-coagulant therapy.

TB-402 is a recombinant human monoclonal antibody that targets Factor
VIII, a key component of the coagulation cascade. TB-402 is a novel
anticoagulant agent, which may deliver important clinical benefits due to it
only partially inhibiting Factor VIII activity even when given in very high
doses. This novel mode of action is expected to reduce the risk of
undesirable bleeding events and the need for patient monitoring, the two main
drawbacks associated with current anticoagulants. In addition, TB-402 is a
long-acting agent which means that patients are expected to receive just one
single dose after surgery to prevent the development of DVT, as opposed to
all current treatment options which 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 will assess three
different doses of TB-402 given as a single intravenous bolus injection post
knee replacement surgery. The trial will enrol 300 patients across 36 centers
mainly in Central Europe. The primary endpoint is the safety and efficacy of
the three escalating doses of TB-402. It is anticipated that the study will
conclude by the end of 2010.

Patrik De Haes, CEO of ThromboGenics, commented on today’s news “We are
very excited about the start of the Phase II trial for TB-402. Our work to
date suggests that this novel agent could represent a major advance in
anti-coagulant therapy, given our expectation that it will cause fewer
unwanted bleeding events and will require no monitoring of patients. This
combined with its ability to be used as a “one-off” treatment could make
TB-402 the anti-coagulant of choice to prevent DVT in patients undergoing
surgery. Given the size of the market opportunity for TB-402 and the sales
reach that will be needed to engage with 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.”

Svein Mathisen, CEO of BioInvent, also commented, “The initiation of this
Phase II trial is another successful step forward in the clinical development
of our antibody product development portfolio. TB-402 addresses a broad
market and has potentially significant advantages over existing
anti-coagulants. We are hopeful it will have application in a number of
clinical settings.”

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 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.

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 biotechnology company focused on the discovery and
development of 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 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 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.

About BioInvent

BioInvent International AB, listed on the OMX Nordic Exchange 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,
OrbusNeich, Sanofi-Aventis, UCB and XOMA. More information is available at
http://www.bioinvent.com.

(1) “The Surgeon General’s Call to Action to Prevent Deep Vein Thrombosis
and Pulmonary Embolism,” September 15, 2008, p.1.

(2) “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.

    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

    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)20-7457-2020
    E-mail: bioinvent@collegehill.com

SOURCE ThromboGenics NV


Source: newswire