TopoTarget annonces positive phase II data BelCaP study in bladder cancer at AACR-EORTC-NCI 2008 Conference

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

To NASDAQ OMX Copenhagen A/S
Announcement no. 30-08 / Copenhagen, 22 October 2008


Positive BelCaP data in bladder cancer patients in Phase II study presented at
the AACR/NCI/EORTC “Molecular Targets and Cancer Therapeutics” conference 2008 


- TopoTarget announces that belinostat shows promising effect in bladder cancer
in the Phase II study of the BelCaP combination. Furthermore, tomorrow, 23
October, data will be announced from a study of belinostat in combination with
doxorubicin; belinostat administered orally as a capsule and intravenous
belinostat treatment over 3 or 6 hours - 

A conference call will be hosted tomorrow, 23 October 2008 at 2.00 pm (CET) 

Copenhagen, Denmark, 22 October 2008 - TopoTarget A/S (OMX: TOPO) has presented
promising data in bladder cancer using the BelCaP regimen with 1 complete
response (CR), 3 partial responses (PR) and 10 patients out of 15 experiencing
stable disease (SD). The data was presented at the AACR/NCI/EORTC “Molecular
Targets and Cancer Therapeutics” conference 2008. BelCaP (belinostat in
combination with standard doses of carboplatin and paclitaxel) was administered
to patients with bladder cancer, who had previously relapsed from treatment
with carboplatin/cisplatin. 

The study:
A Phase II, open-label, non-randomised multi-center study of the histone
deacetylase inhibitor belinostat in combination with carboplatin and paclitaxel
(BelCaP) for the treatment of patients with urothelial carcinoma of the bladder
(transitional cell carcinoma, or TCC). 

The study shows data from 15 bladder cancer patients, who had all received
prior platinum-based treatment, 14 of which were evaluable. 4 responses have
been observed to date (1 CR and 3 PR): A complete response was observed in a
patient with bladder cancer, who received the BelCaP regimen as 2nd line
treatment; CR was observed following the second cycle of BelCaP treatment, and
the result was confirmed after cycle 4, after which the patient received
consolidation radiotherapy. A partial response (PR) was observed in a patient
who received the BelCaP regimen as 2nd line treatment; PR was observed
following the second cycle and was increased to a non-confirmed complete
response (CR) following cycle 4; after discontinuing the BelCaP treatment, the
patient received radiotherapy. A partial response was observed in a patient
receiving the BelCaP combination as 2nd line treatment; PR was confirmed
following cycle 4, and the patient discontinued the treatment after cycle 5 due
to an allergic reaction. A partial response was observed in a patient receiving
BelCaP as 3rd line treatment; PR was observed following cycle 2 and confirmed
after cycle 3. The patient went off the study after cycle 4 due to relapse. 

In addition, 10 patients experienced disease stabilisation (SD) with the
longest stabilisation period being 6 and 7 treatment cycles of 3 weeks. Both
these patients received BelCaP as 2nd line treatment. 
One patient continues on therapy (ongoing).


Best response waterfall plot. Please see attached pdf file.

Conclusion:

The BelCaP regimen, which is a combination of belinostat (an HDACi) and
carboplatin and paclitaxel, has a safety profile comparable to that of
carboplatin and paclitaxel administered alone. With 4 responses (1 CR and 3 PR)
out of 14 evaluable patients, this regimen shows promising activity in patients
with pre-treated bladder cancer. 

Today's announcement does not change TopoTarget's full-year financial guidance
for 2008. 

Conference call
A conference call to provide an update on the clinical development of
belinostat will be hosted by Peter Buhl, CEO and Jan Fagerberg Medical
Director, Belinostat Project Leader and will be followed by a question and
answering session. The conference call takes place on October 23 at 2.00 pm
(CET). 
A presentation will be available at www. Topotarget.com before the
teleconference 

To participate in the conference call please dial:
From Denmark: 70 26 50 40
Outside Denmark: +45 70 26 50 40 or +44 208 817 9301
A replay of the conference call will be available approximately two hours after
the conference call and until October 30, 2008 at 5.00 pm (CET) at the
following number: +353 1 436 4267 pin code 1445475#. 

TopoTarget  A/S
	
For further information, please contact:

Ulla Hald Buhl 		Telephone	+45 39 17 83 92
Director IR & Communications		Mobile	+45 21 70 10 49
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, cis-retinoic acid,
azacitidine 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 is currently being evaluated in multiple clinical trials
as a potential treatment for cutaneous and peripheral T-cell lymphomas, B-cell
lymphomas, AML, mesothelioma, soft tissue sarcoma, MDS, and liver, colorectal,
and ovarian cancers, either alone or in combination with anti- cancer
therapies.  An oral formulation of belinostat is also being evaluated in a
Phase I clinical trial for patients with advanced solid tumors. Several trials
in the belinostat program are conducted under a Clinical Trail Agreement (CTA)
under which the NCI sponsors clinical trials to investigate belinostat for the
treatment of various cancers, both as a single-agent and in combination
chemotherapy regimens.  In May 2005, TopoTarget announced the signing of 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. 

About TopoTarget 
TopoTarget (OMX: TOPO) is an international biotech company headquartered in
Denmark, dedicated to finding ''Answers for Cancer'' and developing improved
cancer therapies. The company is founded and run by clinical cancer specialists
and combines years of hands-on clinical experience with in-depth understanding
of the molecular mechanisms of cancer. Focus lies on highly predictive cancer
models and key cancer targets (including HDACi, NAD+, mTOR, FasLigand and
topoisomerase II inhibitors). TopoTarget has a broad cllinical pipeline with 9
products in development, including belinostat which has shown proof of concept
as monotherapy in treating haematological malignancies and positive results in
solid tumours where it can be used in combination with full doses of
chemotherapy. The company's first marketed product Savene®/Totect® was approved
by EMEA in 2006 and the FDA in 2007 and is marketed by TopoTarget's own sales
force in Europe and the US. 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 expo-sure; 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.