Copenhagen, Denmark - 13 September, 2011 - Today Topotarget A/S (NASDAQ OMX:
TOPO.CO) announcedthat clinical data on belinostat will be presented at The
European Multidisciplinary Cancer Congress in Stockholm, 23-27 September 2011.

Below is a list of the two abstracts accepted at The European Multidisciplinary
Cancer Congress http://stockholm2011.ecco-org.eu/Programme;


Abstract 6597, Monday 26 September, time: 8.00-10.00, Hall C

A phase II study of epigenetic therapy using belinostat for patients with
unresectable hepatocellular carcinoma: a multicenter study of the Mayo Phase 2
Consortium (P2C) and the Cancer Therapeutics Research Group (CTRG)

W. Yeo1, H.C. Chung2, S.L. Chan1, L.Z. Wang,3 R. Lim3, J. Picus4, M. Boyer5, C.
Erlichman6, A.T.C. Chan1, B.C. Goh3. Department of Clinical Oncology1, Chinese
University of Hong Kong, Hong Kong. Division of Haematology-Onology, Yonsei
Cancer Center, Yonsei University College of Medicine, Korea2. Department of
Haematology-Oncology, National University Hospital, Singapore3. Washington
University, School of Medicine, St. Louis, MO, USA4. Sydney Cancer Centre,
Royal Prince Alfred Hospital, Australia5. Mayo Phase 2 Consortium6.

Background: Patients with unresectable hepatocellular carcinoma (HCC) carry a
dismal prognosis. Epigenetic aberrations have been reported in HCC. Belinostat
is a novel, low molecular weight, histone deacetylase inhibitor. The purpose of
this study was to assess the efficacy of epigenetic therapy with belinostat in
patients with unresectable HCC.

Patients and methods: Major eligibility criteria included histologically
confirmed HCC that is not amenable to curative treatment; ECOG£2; adequate
organs functions. The belinostat dose used was 1400 mg/m2/day i.v. on day 1-5
every 3 weeks, as defined in a prior phase I study. The primary endpoint was
progression-free survival (PFS) and the secondary endpoints were response rate
(RR) according to RECIST and overall survival (OS). Adverse events were
reported using CTCAE v3.

Results: 42 patients were accrued. Prior therapies included surgery (36%),
radiofrequency ablation (7%), transarterial therapy (50%); prior systemic
therapies (38%). Median follow-up was 20.0 months. Median cycle no. was 2
(range: 1-12). The PR and SD rate was 2.4% (1/42) and 45.2% (19/42)
respectively. Median PFS was 2.64 months (95%C.I. 1.55-3.17) and OS was 6.60
months (95%C.I. 4.53-11.60). Grade >3 toxicities that occurred in >5% included:
4 (9.5%) abdominal pain, 4 (9.5%) hyperbilirubinemia, 4 (9.5%) raised alanine
transaminase, 3 (7.1%) anemia, 3 (7.1%) vomiting, 2 (4.8%) distension, 2 (4.8%)
hemorrhage, 2 (4.8%) prolonged QTc and 2 (4.8%) dehydration. One patient
developed sudden death but it was determined not likely due to study
medication.

Conclusions: With the majority of patients having failed prior therapy,
epigenetic therapy with belinostat demonstrates tumor stabilization and is
generally well-tolerated. Further studies including combinational study with
other agents is warranted.

Acknowledgement: The study was sponsored by the Division of Cancer Treatment
and Diagnosis, National Cancer Institute, U.S.A, and its collaborator
TopoTarget.



Abstract 7105, Sunday 25 September, time: 11-12, Hall A8

Belinostat in Combination With Carboplatin and Paclitaxel (BelCaP) for
Treatment of Bladder Cancer - a Pharmacokinetic Study of Exposure to Belinostat
and Its Metabolites

Co-authors: R.J. Jones1, J. Tjørnelund2, K.D. Erichsen3, L. Sengeløv4, J. De
Bono5
1Cancer Research UK Beatson Laboratories, Centre for Oncology and Applied
Pharmacology, Glasgow, United Kingdom ; 2Topotarget, Clinical Pharmacology,
Copenhagen, Denmark ; 3Topotarget, Medical Affairs, Copenhagen, Denmark ;
4Herlev Hospital, Department Oncology, Copenhagen, Denmark ; 5Royal Marsden
Hospital, Institute for Cancer Research, Sutton, United Kingdom

Background: Belinostat (Bel, PXD101) is a class I and II Histone DeACetylase
(HDAC) inhibitor. A single arm Ph II study was conducted to evaluate the safety
and activity of Belinostat, Carboplatin and Paclitaxel (BelCaP) in patients
(pts) with Transitional Cell Carcinoma of the Bladder (TCCB) (n=15). A part of
the study was a pharmacokinetic study of plasma exposure to Bel and its
metabolites. The in vitro efficacy of belinostat and its metabolites were
compared and related to plasma exposure in pts.

Materials and Methods: Pts with TCCB were treated with BelCaP every third week;
Bel was given as a 1000mg/m2 30-min i.v. inf. on days 1-5 with P (175mg/m2) and
subsequently Ca (AUC5) administered 2-3hrs after Bel on day 3. The plasma
exposure (AUC) of Bel and its metabolites were determined. The in vitro
pharmacological effect of Bel and its five major metabolites: belinostat
glucuronide (BelGlcU), 3-(Anilinosulfonyl)benzene carboxylic acid (3-ASBA),
methylated belinostat (Metbel), belinostat amide (Belam) and belinostat acid
(Belac) were examined in a HeLa HDAC enzyme inhibition assay (HDAC-i), in WST
proliferation assays and in clonogenic assays (CA). Fold differences in
exposure of metabolites and belinostat (10 pts on day 3) and fold differences
in in vitro efficacy of belinostat and metabolites were compared.

Results: The exposure of each metabolite relative to Bel was evaluated. The
increases (molar AUC0-∞) relative to Bel were 16- (BelGlcU), 3- (3-ASBA), 1-
(Metbel), 1- (Belam) and 0.5-fold (Belac).

Bel metabolites did not inhibit HDAC-i activity or cell WST proliferation in
vitro. In the CAs the IC50 for Bel were 0.4 to 1.3µM. Three metabolites had
weak effect relative to Bel. The fold increase in IC50 relative to Bel was: >65
(BelGlcU), >42 (Metbel) and >114 (Belam).

Conclusions: Five major human Bel metabolites (BelGlcU, 3-ASBA, Metbel, Belam
and Belac) were identified in a Ph II study of BelCaP in pts with TCCB. Bel
metabolites were inactive in HDAC-i assays and in WST assays and had weak
activity in CA. The metabolite with highest fold exposure compared to Bel was
BelGlcU (16-fold), which was 65 fold less effective in vitro than Bel. The
present study finds that Bel metabolites do not have significant biological
effect at therapeutic relevant plasma exposure in cancer pts.



Today's news does not change Topotarget's full-year financial guidance for 2011.


Topotarget A/S

For further information, please contact:

Francois Martelet, CEO: Direct: +45 39 17 83 41; Mobile: +45 51
32 83 41

Axel Mescheder, CMO: Direct: +45 39 17 83 14; Mobile: +45 51
55 71 66

Annette Lykke, IR Direct: +45 39 17 83 44; Mobile:
+45 23 28 98 14


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, 5-FU, etoposide 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, or
programmed cell death; promote differentiation; inhibit angiogenesis; and
sensitize cancer cells to overcome drug resistance when used in combination
with other anti-cancer agents.

Intravenous belinostat (IV) is in pivotal trial in peripheral T-cell lymphoma
(PTCL) and is currently being evaluated in multiple clinical trials as a
potential treatment for cancer of unknown primary (CUP), ovarian cancer, small
cell lung cancer, thymoma, liver, soft tissue sarcoma, lymphoma, AML, and
Myelodysplastic Syndrome (MDS), either alone or in combination with other
anti-cancer therapies. Continuous intravenous administration (CIV) is being
evaluated in clinical trials in solid tumours as well as in AML. Topotarget has
a Clinical Trial Agreement (CTA) with the NCI to clinical studies on belinostat
in order to better understand its anti-tumor activity.


About Topotarget

Topotarget (NASDAQ OMX: TOPO.CO) 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 site
(CUP). Topotarget's cancer drug target is HDAC. 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 commercialize 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 enrollment 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 16-11 ESMO-ECCO.pdf