Quantcast

ThromboGenics and BioInvent Complete Phase I Patient Trial of Anti-PlGF Cancer Therapeutic TB-403 in Patients With Advanced Solid Tumours

November 16, 2009

LEUVEN, Belgium and LUND, Sweden, November 16 /PRNewswire-FirstCall/ –
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 development.

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:

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, Belgium. 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 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 http://www.bioinvent.com.

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.

    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, Katja Stout, John McIntyre
    Tel: +44(0)20-7457-2020
    Erik Clausen, Kena Hudson (US)
    Tel: +1-415-230-5385
    E-mail: bioinvent@collegehill.com

SOURCE ThromboGenics NV


Source: newswire



comments powered by Disqus