ThromboGenics and BioInvent Complete Phase I Patient Trial of Anti-PlGF Cancer Therapeutic TB-403 in Patients With Advanced Solid TumoursBy Thrombogenics Nv, PRNE
Sunday, November 15, 2009
LEUVEN, Belgium and LUND, Sweden, November 16 - ThromboGenics NV (Euronext Brussels: THR) and BioInvent
International AB (OMXS: BINV) today announced positive results from a Phase I
trial of their novel anti-cancer monoclonal antibody TB-403 in patients with
advanced solid tumours. The results were presented at the AACR-NCI-EORTC
International Conference on Molecular Targets and Cancer Therapeutics in
Boston, U.S. TB-403 was well tolerated with no reported dose limiting
toxicity. These positive data support progression of TB-403 and further
The novel mechanism of action of TB-403 represents a
potentially promising cancer therapy. It is a humanized monoclonal antibody
directed towards placental growth factor (PIGF), expected to act by blocking
the formation of the new blood vessels that are required for tumour growth.
Preclinical exploration of PIGF biology suggests a role in tumour
angiogenesis and metastasis and a limited role in the maintenance of normal
vasculature. This mode of action could result in therapeutic benefit with an
acceptable side effect profile.
The multi-centre, dose escalation study was conducted in 23
patients and was designed to both determine the maximum tolerated dose of
TB-403 and to evaluate safety and tolerability in patients with advanced
solid tumours. TB-403 is licensed by ThromboGenics and BioInvent to Roche
under an agreement signed in June 2008.
TB-403 was shown to be well tolerated and no dose limiting
toxicity was observed with doses up to 10 mg/kg weekly and 30 mg/kg every
three weeks. In this patient population with advanced solid tumours, stable
disease was observed in six of 23 patients. In the case of the two patients
who were treated with 5 mg/kg TB-403 weekly, their disease was stable for
approximately 12 months.
Detailed results of an earlier Phase I trial in healthy
volunteers, also presented at the meeting, showed that TB-403 demonstrated a
good safety profile with no serious adverse effects reported.
Dr. Patrik De Haes, CEO of ThromboGenics, commented: "We are
very pleased that the results we have announced today have given us
confidence to move forward in development of TB-403. The early efficacy data
in this difficult patient population reflect the promise of this selective
anti-angiogenesis approach to anti-cancer therapy. We very much look forward
to continuing the excellent working relationship with both Roche and
BioInvent, our partners on TB-403, and reporting the future progress of such
an exciting and unique anti-cancer agent."
Svein Mathisen, CEO of BioInvent, also commented, "We are
delighted that this Phase I trial has shown TB-403 to be safe and well
tolerated also in patients with solid tumours. Although this is still early
stage data, the results so far are encouraging and add to our excitement
about the potential of this treatment as a significant step forward in cancer
treatment. We look forward to progressing TB-403 into further development."
Notes to Editors:
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, Belgium. The Company is listed on Eurolist by
Euronext Brussels under the symbol THR. More information is available at
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
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.
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
For further information, please contact: ThromboGenics NV Patrik De Haes, MD Chief Executive Officer Tel : +32(0)16-75-13-10 E-mail: email@example.com Andy De Deene, MD Clinical Director Europe Tel: +32(0)16-75-13-10 E-mail: firstname.lastname@example.org Citigate Dewe Rogerson Amber Bielecka, David Dible, Nina Enegren Tel: +44(0)207-638-95-71 E-mail: email@example.com BioInvent International AB Svein Mathisen President & CEO Tel: +46(0)46-286-85-67 Mobile: +46(0)708-97-82-13 E-mail: firstname.lastname@example.org Cristina Glad Executive Vice President Tel: +46(0)46-286-85-51 Mobile: +46(0)708-16-85-70 E-mail: email@example.com College Hill (media enquiries) Holly Griffiths, Katja Stout, John McIntyre Tel: +44(0)20-7457-2020 Erik Clausen, Kena Hudson (US) Tel: +1-415-230-5385 E-mail: firstname.lastname@example.org
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 at thrombogenics.com; Andy De Deene, MD, Clinical Director Europe, Tel: +32(0)16-75-13-10, E-mail: andy.dedeene at thrombogenics.com; Citigate Dewe Rogerson, Amber Bielecka, David Dible, Nina Enegren, Tel: +44(0)207-638-95-71, E-mail: amber.bielecka at 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 at 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 at bioinvent.com; College Hill (media enquiries), Holly Griffiths, Katja Stout, John McIntyre, Tel: +44(0)20-7457-2020, Erik Clausen, Kena Hudson (US), Tel: +1-415-230-5385, E-mail: bioinvent at collegehill.com
Tags: belgium, Belgium And Lund, Leuven, sweden, ThromboGenics NV