TopoTarget provides update on clinical potential and latest data on belinostat via teleconf September 17- and announces BelCaP data from ESMO


TopoTarget A/S
Symbion
Fruebjergvej 3
DK 2100 Copenhagen Ø
Denmark
Tel: +45 39 17 83 92
Fax: +45 39 17 94 92
CVR-nr: 25695771

www.topotarget.com

To the OMX Nordic Exchange Copenhagen, Investor News
Investor News No. 07-08 / Copenhagen, September 15, 2008


-TopoTarget to provide update on clinical potential and the latest data on
belinostat via conference call on 
September 17-

-Announcement of final data from phase I part of the BelCaP study and update on
positive data from the phase II part with BelCaP for ovarian cancer as
presented at ESMO in Stockholm- 

Copenhagen, Denmark - September 15, 2008- TopoTarget A/S (OMX:  TOPO) today
announced that TopoTarget will host a teleconference on the September 17 to
provide an update of clinical possibilities and the latest data with
belinostat. 
Furthermore as promised data from the ovarian phase I/II trial with BelCaP
(belinostat+carboplatin+taxol) was presented at the 33rd ESMO (European Society
for Medical Oncology) Congress, Stockholm, Sweden 12-16 September 2008. In the
phase I part of the study where final data now are presented to the medical
doctors activity was observed in heavily pre-treated patients including
diagnoses of carcinoma of unknown primary tumour (CUP), ovarian, rectal,
pancreatic and bladder cancer. The data presented and announced for the phase
II part was identical with the positive data presented at last weeks ovarian
cancer meeting in Seattle where the over all response rate was 43%; 3 complete
remissions (CR) and 12 partial remissions (PR) were demonstrated in 35
patients. 

In the phase I part where the data has now been finalized 23 patients were
treated to find the recommended dose for phase II, which was belinostat 1000
mg/m2 i.v. once daily days 1-5 in combination with standard doses of
carboplatin and paclitaxel administered on day 3 of each treatment cycle. In
this group of heavily pretreated patients 2 confirmed partial remissions (PR)
were documented in rectal cancer and in pancreatic cancer, respectively. and
Activity was observed in patients with primary tumour (CUP), ovarian, rectal,
pancreatic and bladder cancer. 11 patients experienced stable disease (SD)
ranging from 2 to +28 cycles. 

In the phase II part (no major changes of data as reported at the Biennial
Ovarian Cancer Research Symposium 4-5 September 2008) 35 patients with ovarian
cancer all had prior platinum-based therapy (14 and 21 patients had
platinum-sensitive and platinum-resistant disease, respectively).  In the whole
population, overall response rate measured by RECIST (Response Evaluation in
Solid Tumours) criteria was 43%. 3 patients had complete remissions (CR) and 12
partial remissions (PR). Median duration of response was +5.3 months (range
+1.2-+12.7 months) with 6 responses still ongoing. Median progression-free
survival in all 35 patients (11 patients censored for PD) is currently +5.4
months (range +0.1 to +13.9 months) 

Conclusions from the authors included that BelCaP (belinostat combined with
standard doses of carboplatin and paclitaxel) is well-tolerated presenting a
safety profile consistent of that observed with chemotherapy alone, and that
the substantial anti-tumour activity observed in both platinum-sensitive and
platinum-resistant ovarian cancer, including patients with a platinum-free
interval of < 3 months, supports further development of BelCaP in patients with
recurrent ovarian cancer. 


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 September 17 at 10.00
CET. 
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 September 24, 2008 at 5.00 pm (CET) at the
following 
number: +353 1 436 4267 pin code 1397856#.

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

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 TopoTarget 
TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark and with
subsidiaries in the US, Switzerland, Germany and the UK, dedicated to finding
''Answers for Cancer'' and developing improved cancer therapies. TopoTarget 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) and a
strong development foundation has been built. TopoTarget has a broad portfolio
of small molecule pre-clinical drug candidates and nine drugs (both small
molecules and protein based) are in clinical development, including both novel
anti-cancer therapeutics and new cancer indications for existing drugs.
Savene®/Totect™ were approved by EMEA in 2006 and the FDA in 2007 and is
TopoTarget's first product on the market. 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.

Attachments

investor news no. 07-08 esmo belcap ph i and ii ovarian 15 september 08.pdf