Copenhagen, Denmark - 29 December, 2010 - Topotarget A/S (NASDAQ OMX: TOPO)
announced today that the first patient has been dosed in the Investigator
Initiated trial of belinostat with Tarceva® given to patients with Non-Small
Cell Lung Cancer (NSCLC).

The study is an open-label, prospective Phase I/II trial of belinostat in
combination with Tarceva® in patients with previously treated Non-Small Cell
Lung Cancer (NSCLC). Belinostat is given orally on days 1-14 whilst Tarceva® is
administered orally continuously. The Phase I/II trial is expected to include a
total of 35 patients and will be conducted at Herlev Hospital, Denmark.

The primary objective of the study is to evaluate the safety of belinostat in
combination with Tarceva® and to generate efficacy data in terms of
progression-free survival, response rate and overall survival in patients with
NSCLC.

“We are delighted to announce that the recruitment of this Investigator
Initiated Phase I/II trial has enrolled its first patient. This is an important
step for Topotarget marking the translational approach in our selection of
treatment of patients with solid tumors. We have solid pre-clinical data
showing synergy between belinostat and Tarceva®, which led to this Investigator
Initiated trial”, said Francois Martelet, MD, CEO of Topotarget.


Today's news does not change Topotarget's full-year financial guidance for 2010.


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 2 in cancer of unknown primary site
(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.

Announcement No 33-10 Phase I-II belinostat and Tarceva trial in patients with NSCLC has enrolled first patient.pdf