Positive belinostat data in cutaneous lymphomas presented at EORTCs lymphoma meeting in Copenhagen


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
Positive belinostat data in cutaneous lymphomas presented at EORTCs lymphoma
meeting in Copenhagen 

Copenhagen, Denmark - September 8, 2008 - TopoTarget A/S (OMX: TOPO)  announces
that positive data from a belinostat phase II study in patients with relapsing
or resistant peripheral or cutanous lymphoma (PTCL and CTCL) was presented at
the ”CUTANEOUS LYMPHOMAS : FROM THE MOLECULE TO THE CLINIC” in Copenhagen 5-7
September 2008. 

At the EORTC meeting Dr. Kim (Stanford, USA) and colleagues presented updated
results from TopoTarget's phase II study with belinostat for the treatment of
cutaneous lymphomas: 2 patients with complete response (CR) and 2 with partial
response (PR) of 21 evaluable patients. Response in CTCL was seen relatively
fast with a median of 15.5 days, which is clinically relevant. Further more a
considerably number of patients with stable disease (SD) was observed. 

The treatment with intravenously administered belinostat was safe and well
tolerated. The objective response rate fulfills the predefined criteria for the
continuation of the study into the next phase: the “Simon two-stage” design. 
The corresponding results in a group of patients with T-Cell lymphoma were as
announced earlier this year also positive, two out of 11 evaluable patients
with PTCL showed prolonged and continuous complete responses (CR) after
treatment with belinostat as monotherapy. It is in the PTCL indication that
TopoTarget has just agreed with the FDA the design of its pivotal phase III
study. 


“It is very positive that we now see positive data emerge from the many studies
running with belinostat. The CTCL study is one of several where we see
belinostat resulting in complete disappearance of the cancer measured by
repeated scans,” 
says professor Peter Buhl Jensen, MD, CEO of TopoTarget.


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

TopoTarget  A/S

For further information, please contact:

Peter Buhl, CEO 		Telephone	+45 39 17 83 92
			Mobile	+45 21 60 89 22


Background information

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 clinical 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.

Attachments

announcement no 29-08 positive data in belinostat  in ctcl at eortcs meeting in copenhagen september 8 2008.pdf