BioInvent International AB (STO:BINV) and co-development partner
ThromboGenics NV (Euronext Brussels: THR) announce today that their
partner Roche (SIX: RO, ROG; OTCQX: RHHBY) has dosed the first patient
in a phase Ib/II study with the novel antibody anti-cancer agent TB-403
(RG7334). The trial is in patients with glioblastoma multiforme, the
most common and aggressive type of primary brain tumour in humans.
The multi-center, phase Ib/II trial will examine the safety and clinical
effect of TB-403 in combination with Avastin® (bevacizumab)
in patients with recurrent glioblastoma. Secondary objectives include
safety, tolerability and pharmacokinetics of the combination. The trial
will also include an evaluation of candidate biomarkers. The study will
recruit approximately 100 patients.
The start of the phase Ib/II glioblastoma study has triggered a €4
million milestone payment to ThromboGenics and BioInvent. This is the
second clinical milestone that they have received from Roche. The first
milestone of €10 million was paid last year when Roche initiated an
imaging study in patients with colorectal and ovarian cancer.
In March 2011, Roche initiated a phase Ib study of TB-403 in patients
with primary liver cancer (hepatocellular carcinoma). This study will
determine the safety, tolerability and dosage of TB-403 in combination
with Nexavar® (sorafenib), as well as pharmacokinetics and
pharmacodynamics. The study will recruit 60-70 patients.
Svein Mathisen, CEO of BioInvent commented, "We are very pleased
that Roche has decided to take TB-403 to the next stage of its
development. We believe that TB-403 could make a major contribution to
the armamentarium used to treat cancer. In glioblastoma, the medical
need is significant and it is our hope that this unique product
candidate could improve the prospects for this patient group whose
current treatment options are very limited.”
Dr Patrik De Haes, CEO of ThromboGenics, added, "The start of
these trials reflects a great interest in evaluating TB-403, in
combination with more established oncology drugs, in a range of cancer
indications. The glioblastoma study, using TB-403 together with Avastin,
is designed to find better treatment options for patients with this very
aggressive form of brain cancer. I believe that these studies will
confirm that the further development of this novel selective
anti-angiogenic antibody is warranted.”
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Notes to Editors:
About TB-403
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.
Two
phase I clinical trials have found that TB-403 was well tolerated with
no reported dose limiting toxicity.
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 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.
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 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 with
Roche.
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.
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.
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 7.30 a.m. CET, on 16 May, 2011.
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