Topotarget A/S
Symbion
Fruebjergvej 3
DK-2100 Copenhagen
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771
www.topotarget.com
Copenhagen, Denmark - 9 December 2010 - Topotarget A/S (NASDAQ OMX: TOPO)
announced today that the first patient has been dosed in a Topotarget
co-sponsored phase 1 study of belinostat in combination with warfarin in
patients with solid tumors or hematological malignancies. The primary study
objective is to determine if belinostat has interaction with warfarin. The
study is expected to recruit 24 patients.
The study
A Phase 1 Study of Belinostat in Combination with Warfarin in Patients with
Solid Tumors or Hematological Malignancies
The study is an open-label, single center, pharmacokinetic and pharmacodynamic
study in patients with solid tumors or hematological malignancies. In the
initial phase up to 24 patients will receive oral Warfarin on day -14, and on
day 3, given 2 hours before the start of belinostat infusion; and belinostat
1000 mg/m² as a 30 minute daily IV infusion on Days 1-5. Blood samples, urine
samples, electrocardiogram (ECG) data, and safety measurements will be
collected up to day 10. Patient can remain on study after the first cycle for a
total of six cycles. The treatment cycles will be of 21 days each.
Primary Objective
The primary objective will be to determine pharmacodynamics effects on the
combination of belinostat and warfarin. Safety and efficacy of belinostat will
also be evaluated.
Today's news does not change Topotarget's full-year financial guidance.
Topotarget A/S
For further information, please contact:
Francois Martelet, CEO: Direct: +45 39 17 83 43; Mobile: +45 51 32 83 41
Anders Vadsholt, CFO: Direct: +45 39 17 83 45; Mobile: +45 28 98 90 55
Background information
About belinostat
Belinostat is a promising small molecule HDAC inhibitor being investigated for
its role in the treatment of a wide range of solid tumors and hematologic
malignancies either as a single-agent, or in combination with other active
anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin,
cis-retinoic acid, azacytidine and Velcade® (bortezomib) for injection. HDAC
inhibitors represent a new mechanistic class of anti-cancer therapeutics that
target HDAC enzymes, and have been shown to: arrest growth of cancer cells
(including drug resistant subtypes); induce apoptosis, (programmed cell death);
promote differentiation; inhibit angiogenesis; and sensitize cancer cells to
overcome drug resistance when used in combination with other anti-cancer
agents. Company-sponsored trials of IV-administered belinostat include a
pivotal trial in peripheral T-cell lymphoma (PTCL), a randomized controlled
Phase 2 trial in cancer of unknown primary (CUP), and studies in ovarian,
colorectal and soft tissue sarcoma patients. NCI-sponsored trials (single agent
and in combination with anti-cancer therapeutics) with IV-administered
belinostat include studies in hepatocellular, thymoma, Myelodysplastic Syndrome
(MDS), and other solid and hematologic cancers. Continuous intravenous
administration (CIV) is being evaluated in clinical trials in solid tumours as
well as in AML. An oral formulation of belinostat is also being evaluated in a
Phase 1 clinical trial for patients with advanced solid tumors and lymphomas.
NCI-sponsored clinical trials are being conducted under a clinical trials
agreement between NCI and Topotarget. Furthermore Topotarget has a Cooperative
Research and Development Agreement (CRADA) with the NCI to conduct preclinical
and nonclinical studies on belinostat in order to better understand its
anti-tumor activity and to provide supporting information for clinical trials.
The NCI is an agency of the US government that oversees the US National Cancer
Program, conducts cancer research, and provides funding for research and
training.
About Topotarget
Topotarget (NASDAQ OMX: TOPO) is a Scandinavian based international biotech
company headquartered in Denmark, dedicated to improve cancer therapies. In
collaboration with Spectrum Pharmaceuticals, Inc. Topotarget currently focuses
on the development in pivotal studies of its lead drug candidate, belinostat,
which has demonstrated a clear anti neoplastic effect in both hematological
malignancies and solid tumors. Belinostat can be used in combination with full
doses of chemotherapy, and is currently in a pivotal trial within PTCL
(peripheral T-cell lymphoma) and phase II in cancer of unknown primary (CUP).
Topotarget's key cancer drug targets are HDAC, NAD+, mTOR, Fas ligand and
topoisomerase II. Totect® is a product on the market developed from
Topotarget's drug discovery technology. Totect® is marketed by the company's
own sales specialists in the US. The European rights to Savene® were divested
in March 2010 as a consequence of the focus to develop and commercialise
belinostat. For more information, please refer to www.topotarget.com.
Topotarget Safe Harbour Statement
This announcement may contain forward-looking statements, including statements
about our expectations of the progression of our preclinical and clinical
pipeline including the timing for commencement and completion of clinical
trials and with respect to cash burn guidance. Such statements are based on
management's current expectations and are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those
described in the forward-looking statements. Topotarget cautions investors that
there can be no assurance that actual results or business conditions will not
differ materially from those projected or suggested in such forward-looking
statements as a result of various factors, including, but not limited to, the
following: The risk that any one or more of the drug development programs of
Topotarget will not proceed as planned for technical, scientific or commercial
reasons or due to patient enrolment issues or based on new information from
non-clinical or clinical studies or from other sources; the success of
competing products and technologies; technological uncertainty and product
development risks; uncertainty of additional funding; Topotarget's history of
incurring losses and the uncertainty of achieving profitability; Topotarget's
stage of development as a biopharmaceutical company; government regulation;
patent infringement claims against Topotarget's products, processes and
technologies; the ability to protect Topotarget's patents and proprietary
rights; uncertainties relating to commercialization rights; and product
liability exposure; We disclaim any intention or obligation to update or revise
any forward-looking statements, whether as a result of new information, future
events, or otherwise, unless required by law.
