ThromboGenics NV (Euronext Brussels: THR) and co-development partner
BioInvent International AB (Nordic Exchange: BINV) 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 tumors.
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 ThromboGenics and
BioInvent 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.
Professor Desire Collen, CEO and Chairman of ThromboGenics, commenting
on today's announcement said: "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."
Svein Mathisen, CEO of BioInvent, added: "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."
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.
About ThromboGenics
ThromboGenics 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
thrombogenics.
About BioInvent
BioInvent International AB, listed on The Nordic Exchange (OMXS: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-Abello, ImmunoGen, OrbusNeich, Sanofi-Aventis, UCB
and XOMA.
ThromboGenics NV
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