Positive TB-402(Anti-Factor VIII Antibody) Phase II Data Published in Journal of Thrombosis and HaemostasisBy Thrombogenics Nv, PRNE
Thursday, February 10, 2011
LEUVEN, Belgium and LUND, Sweden, February 11, 2011 - ThromboGenics NV (Euronext Brussels: THR) and co-development
partner BioInvent International (OMXS: BINV) announce today that the positive
TB-402 (Anti-Factor VIII) Phase II trial results, evaluating the product's
efficacy and safety for the prevention of venous thromboembolism (VTE)
afterorthopaedic surgery, have been published in the Journal of Thrombosis
A paper entitled "Single Intravenous Administration of TB-402
for the Prophylaxis of Venous Thromboembolism after Total Knee Replacement: A
Dose-Escalating, Randomised, Controlled Trial" has been published online
ahead of print in JTH. This publication covers a recently completed dose
finding Phase II trial with TB-402, with the objective of evaluating the
efficacy and safety of three dose levels of single intravenous injection of
TB-402 for preventing VTE after total knee surgery. The trial compared TB-402
withenoxaparin (Lovenox, sanofi-aventis), the standard treatment to prevent
VTE in this setting.
The study showed that TB-402 was associated with a lower rate
of VTE compared with enoxaparin. Pooled results of the TB-402 groups (0.3
mg/kg, 0.6 mg/kg and 1.2 mg/kg) showed a 22% incidence of total VTE compared
with 39% for enoxaparin. In addition, TB-402 was generally well tolerated and
demonstrated comparable safety to enoxaparin.
The results outlined in the articlehighlight thata single dose
of TB-402 has the potential to improve preventive treatment of VTE after
orthopaedic surgery by providing a stable, long-acting antithrombotic effect.
The single dose administration may overcome poor patient compliance to
therapy, one of the main causes of VTE in the real world. Furthermore,
TB-402's novel mode of action could overcome thefrequent monitoring and dose
adjustment requirements associated with many current anticoagulant
For a full discussion of the results, please refer to the JTH
article. Further information is also included in the ThromboGenics press
release dated 9 July, 2010 (see www.thrombogenics.com).
Professor Peter Verhamme, MD,of the University of Leuven,
Belgium, and corresponding author of the JTHpaper,said, "We are delighted
that these results with TB-402 have been published in a key academic journal.
The trial data discussed in the paper demonstrate the potential benefits of
TB-402 in improving treatments for the prevention of VTE after total knee
surgery via a single dose. I very much look forward to the further
development of TB-402 in this setting."
TB-402 has the potential to be an 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 anticoagulation
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 simple approach to prophylaxis would be an
attractive option, as all current anticoagulant treatment options require
daily treatment for up to several weeks.
About Venous Thromboembolism(VTE)
VTE is the third most common cardiovascular disease after
myocardial infarction and stroke. It includes both deep vein thrombosis
(DVT) and pulmonary embolism (PE). DVT is caused when a blood clot forms in a
deep vein, most commonly in the deep veins of the lower leg.PE occurs when a
blood clot blocks the main artery of the lung or one of its branches. DVT and
PE are major public health issues. It is estimated that in the US alone, more
than 600,000 patients are treated for venous thromboembolisms such as DVT or
PE each year.Moreover, DVT and PE together may be responsible for more
than 100,000 deaths in the US each year.
It is estimated that by 2015, 1.4 million patients will
undergo knee replacement and 600,000 patients will undergo hip replacement in
the US if current trends persist. 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. 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.
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 ocriplasmin
(microplasmin) has completed two Phase III clinical trials for the
pharmacological treatment of symptomatic vitreomacular adhesion (sVMA).
Ocriplasmin 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 in
Phase II, and TB-403 (anti-PlGF) in Phase Ib/II for cancer in partnership
ThromboGenics is headquartered in Leuven, Belgium. The Company
is listed on NYSE Euronext Brussels under the symbol THR. More information is
available at www.thrombogenics.com.
BioInvent International AB, listed on the NASDAQ OMX Stockholm
(BINV), is a research-based pharmaceutical company that focuses on developing
antibody drugs. The Company currently has four clinical development projects
within the areas of thrombosis, cancer and atherosclerosis. The Company has
signed various strategic alliances to strengthen the product pipeline and
increase the likelihood of success. These partners include Genentech, Human
Genome Sciences, Roche and ThromboGenics.
The company's competitive position is underpinned by an in
substance patented antibody development platform. The scope and strength of
this platform is also utilised by partners, such as Bayer HealthCare, Daiichi
Sankyo, Mitsubishi Tanabe, UCB and XOMA.
More information is available at www.bioinvent.com.
Important information about forward-looking statements
Certain statements in this press release may be considered
"forward-looking". Such forward-looking statements are based on current
expectations, and, accordingly, entail and are influenced by various risks
and uncertainties. The Company therefore cannot provide any assurance that
such forward-looking statements will materialize and does not assume an
obligation to update or revise any forward-looking statement, whether as a
result of new information, future events or any other reason. Additional
information concerning risks and uncertainties affecting the business and
other factors that could cause actual results to differ materially from any
forward-looking statement is contained in the Company's Annual Report.
"Single Intravenous Administration of TB-402 for the prophylaxis of
Venous thromboembolism after Total Knee Replacement: A Dose-Escalating,
Randomised, Controlled Trial", Peter Verhamme, MD, Marco Tangelder, MD,
Raymond Verhaeghe, MD, Walter Ageno, MD, Steven Glazer, MD, Martin Prins, MD,
Marc Jacquemin, MD, Harry Büller, MD, JTH.
"The role of oral direct thrombin inhibitors in the prophylaxis of
venous thromboembolism", Hawkins D, Pharmacotherapy, October 24, 2004; 10 Pt
Barclays Capital Equity Research Report on New Anticoagulants, August
"The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis
and Pulmonary Embolism," September 15, 2008, p.1.
"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 Dr. Steve Pakola, CMO Tel: +1(212)201-0920 email@example.com Dr. Patrik De Haes, CEO Tel: +32-16-75-13-10 firstname.lastname@example.org CitigateDeweRogerson David Dible/Nina Enegren/Sita Shah Tel: +44(0)207-638-95-71 email@example.com BioInvent International AB SveinMathisen, President & CEO Tel: +46(0)46-286-85-67 firstname.lastname@example.org Cristina Glad, Executive Vice President Tel: +46(0)46-286-85-51 email@example.com College Hill (media enquiries) Melanie Toyne Sewell, AnastasiosKoutsos Tel: +44(0)20-7866-7856 firstname.lastname@example.org Rebecca Skye Dietrich Tel: +1-857-241-0795 email@example.com
For further information please contact: ThromboGenics, Dr. Steve Pakola, CMO, Tel: +1(212)201-0920, steve.pakola at thrombogenics.com; Dr. Patrik De Haes, CEO, Tel: +32-16-75-13-10, patrik.dehaes at thrombogenics.com; CitigateDeweRogerson, David Dible/Nina Enegren/Sita Shah, Tel: +44(0)207-638-95-71, nina.enegren at citigatedr.co.uk; BioInvent International AB, SveinMathisen, President & CEO, Tel: +46(0)46-286-85-67, svein.mathisen at bioinvent.com; Cristina Glad, Executive Vice President, Tel: +46(0)46-286-85-51, cristina.glad at bioinvent.com; College Hill (media enquiries), Melanie Toyne Sewell, AnastasiosKoutsos, Tel: +44(0)20-7866-7856, bioinvent at collegehill.com; Rebecca Skye Dietrich, Tel: +1-857-241-0795, bioinvent at collegehill.com
Tags: belgium, Belgium And Lund, February 11, Leuven, sweden, ThromboGenics NV