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BioInvent and ThromboGenics report positive Phase I results for anti-PlGF cancer
therapeutic TB-403
- Approval also received to start second repeat-dose
Phase I study in patients with advanced cancer -
Lund, Sweden and Leuven, Belgium – 3 June 2008 - BioInvent International AB (OMX
Nordic Exchange Stockholm: BINV) and co-development partner ThromboGenics NV (Euronext
Brussels: THR) today reported that the results from the first Phase l study of
novel anti-cancer agent TB-403 showed that it is safe and well tolerated, with
pharmacokinetic properties enabling it to be developed for the treatment of
cancer. The companies also announced that they have received approval from the
regulatory authorities in Denmark to initiate a second repeat-dose Phase I
clinical trial of TB-403 in patients with advanced solid tumours.
TB-403 is a monoclonal antibody that targets the angiogenic factor PlGF
(placental growth factor). The product has demonstrated inhibition of PlGF-associated
angiogenesis and tumour growth in animal models, without affecting healthy
tissues. The completed Phase I study was a double-blind, randomised trial
testing a single-dose of TB-403 at three escalating levels or placebo in 16
healthy male subjects. The results of the trial have shown that TB-403 met both
primary endpoints regarding safety and tolerability, and secondary endpoints
examining pharmacokinetics. These results have provided the basis for a safe and
efficient introduction of the compound into a subsequent repeat-dose trial in
patients for which BioInvent and ThromboGenics have now received approval.
The second Phase I trial will be a study of tolerability, pharmacokinetics and
pharmacodynamics in patients with advanced cancer. Up to 30 patients with
metastatic or unresectable solid tumours will be enrolled in this open, dose
escalation multi-dose study. The study will take place in Denmark and patient
recruitment is due to begin shortly.
Svein Mathisen, CEO of BioInvent, commenting on today’s announcement, said: “We
are pleased at the continued progress seen in our collaboration with
ThromboGenics and at the success of this product in Phase I. Based on these
data, we look forward to embarking imminently on the planned second Phase I
study in patients with advanced cancer, while we continue to prepare for future
development and commercialisation.”
Professor Désiré Collen, CEO and Chairman of ThromboGenics, added: "This is an
important milestone for ThromboGenics and our partner BioInvent. This study
reinforces our belief that TB-403 has the potential to become a significant
treatment for cancer due to TB-403’s unique mode of action. TB-403 blocks the
formation of new blood vessels in the cancer tumour without affecting healthy
tissues. We are delighted that the vision we shared with BioInvent is
progressing and with today’s news, is becoming more tangible."
-- END --
Notes to Editors:
About TB-403
Angiogenesis inhibitors such as TB-403 are therapeutic agents that work by
blocking the development of new blood vessels, thereby depriving growing cancer
tumour cells of oxygen and nutrients. This approach in turn is thought to stop
the tumour from growing and spreading to other parts of the body. Currently
available angiogenesis inhibitors specifically target vascular endothelial
growth factor (VEGF), which plays an important role in promoting the formation
of blood vessels. PlGF is a homologue of VEGF but, unlike VEGF, it does not
affect normal, physiological angiogenesis and is only involved in the
angiogenesis in the diseased tissue. Therefore, as an inhibitor of PlGF, TB-403
is likely to inhibit tumour growth without the side effects associated with
other anti-angiogenic therapies.
ThromboGenics and BioInvent also intend to develop TB-403 for eye diseases, to
block uncontrolled blood vessel growth in conditions such as age-related macular
degeneration (AMD) and diabetic retinopathy.
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
Holly Griffiths, Katja Stout, John McIntyre
Tel: +44 (0)20 7457 2020
E-mail: bioinvent@collegehill.com
ThromboGenics NV
Professor Désiré Collen
Patrik DeHaes
Chief Executive Officer
Chief Operating Officer
Tel : +32 (0) 16 34 61 94
Tel : +32 (0) 16 34 61 94
E-mail:
patrik.dehaes@thrombogenics.com
Citigate Dewe Rogerson
David Dible, Sylvie Berrebi, Amber Bielecka
Tel: +44 (0) 20 7282 1050
E-mail:
sylvie.berrebi@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:
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, atherosclerosis and ophthalmic diseases. In January
2007 the Company announced a major strategic alliance with American-based
Genentech, Inc. in the cardiovascular field.
These projects are based on a competitive and in substance patented technology
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.
The Company, which currently has 95 employees, is located at Ideon in Lund.
ThromboGenics NV is a biotechnology company focused on discovery and development
of biopharmaceuticals for the treatment of a range of vascular diseases. The
Company has several programs in Phase II clinical development including
microplasmin, which is being evaluated as a treatment for vitreoretinal
disorders and as a thrombolytic agent for vascular occlusive diseases, including
acute stroke. ThromboGenics is also developing novel antibody therapeutics in
collaboration with BioInvent International; these include TB-402 (Anti-Factor
VIII), scheduled to enter Phase II clinical development in 2008, and TB-403
(Anti-PlGF), which is scheduled to enter a Phase Ib clinical trial in mid-2008
for the treatment of 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
www.thrombogenics.com.
BioInvent International AB (publ)
ThromboGenics NV
Co. reg. No. 556537-7263,
Campus Gasthuisberg
Address: Sölvegatan 41
Herestraat 49
Mailing address: SE-223 70 LUND B-3000
Leuven
Tel: +46 (0)46 286 85 50
Belgium
info@bioinvent.com
Tel: +32 (0) 16 34 61 94
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 8.00 a.m. CET, on 3 June,
2008.
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