TopoTarget announces positive data from a phase II study of belinostat monotherapy

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 OMX Nordic Exchange Copenhagen
Announcement No. 23-08 / Copenhagen, June 6, 2008


TopoTarget announces positive data from a phase II study of belinostat
monotherapy in patients with recurrent or refractory peripheral or cutaneous
T-Cell lymphoma (PTCL and CTCL) and the granting of a Fast Track designation
from FDA for belinostat in PTCL 

Copenhagen, Denmark - June 6, 2008 - TopoTarget A/S (OMX: TOPO) announces that
positive belinostat data were presented at the 10th International Conference On
Malignant Lymphoma in 
Lugano, Switzerland, June 04-07, 2008 from a phase II trial in patients with
recurrent or refractory peripheral or cutaneous T-Cell lymphoma (PTCL and
CTCL). Two durable and still ongoing complete responses with belinostat
monotherapy were demonstrated in 11 evaluable patients with PTCL. Furthermore 4
objective responses, 1 CR (Complete Response) and 3 PR (Partial Response) in 20
heavily pre-treated evaluable patients with CTCL, were evident. Time to
response in CTCL was median 15.5 days and is a promising finding. In addition a
substantial number of patients with stable disease (SD) were observed in both
diseases. Intravenous belinostat was shown to be safe and well tolerated and
the objective response rate in both arms has met the pre-defined criteria for
advancement to the second stage of the Simon two-stage design. Enrolment is
ongoing in the CTCL and PTCL arms of the study to a total of 34 patients per
arm. Additional new centres have been initiated to accelerate recruitment.
Based on the activity in the presented study and a defined development program
FDA has granted a Fast Track designation for the development of belinostat
monotherapy in patients with relapsed or refractory PTCL after at least one
prior systemic therapy. 

“These data are even more promising than those presented at the ASH meeting in
December 2007, especially the durability of the complete remissions in patients
with PTCL are important for the further development in this indication. The
challenge is now to increase patient inclusion in the ongoing study and to
initiate a pivotal study in PTCL. Data presented in Lugano included 36 patients
for both T-cell indications with information on the database as of May 08,
currently we have 42 out of a total 68 patients recruited. New centers have
recently been opened which brought us to more than 20 open sites, our goal for
this study is approximately 30 active sites.” Said MD Professor Peter Buhl
Jensen, CEO of TopoTarget. ”Fast recruitment to this trial is a focus area for
TopoTarget which now, as a sole owner, is concentrating its efforts on the
development of belinostat. In addition, the fast track designation for the PTCL
development from the FDA is an important step for the market advancement of
belinostat” Peter Buhl Jensen further commented. 
 
The study:
Phase II open-label trial of belinostat (PXD101) in patients with recurrent or
refractory Peripheral or Cutaneous T-Cell Lymphoma. 
Background: Belinostat is a small molecule class I and II histone deacetylase
inhibitor (HDACi). HDACi's modulate gene expression within tumor cells,
including tumor suppressor genes, leading to G1 and G2/M cell cycle arrest,
induction of apoptosis (programmed cell death), inhibition of angiogenesis,
immune modulation, and promotion of cellular differentiation. Belinostat
monotherapy at 1000 mg/m2/daily for 5 days in a 3-weekly cycle is
well-tolerated. 

Methods: Primary study objective is objective response rate for belinostat
therapy in CTCL and in PTCL. Main eligibility criteria are patients who have
failed at least one prior line of systemic therapy and who have a Karnofsky
performance status ≥70%. Patients were treated with belinostat administered at
1000 mg/m2, as a 30 min IV infusion once daily on days 1-5 of a 21-day cycle.
For patients with CTCL the assessment of efficacy was evaluated by SWAT
(Severity Weighted Assessment Tool) performed every cycle to assess cutaneous
lesions. For PTCL patients assessment of efficacy was measured by CT scans
every 2 cycles according to standard lymphoma criteria. 

Results: 14 patients with PTCL are included, 11 of which were evaluable for
response. Patients received median of 2 prior therapies and 79% had Stage III
or IV disease. Objective responses were observed in 2 patients (2 CR) and
stable disease (SD) was demonstrated in 4 patients. 
In the CTCL indication 22 patients are included, 20 of which were evaluable for
response. The patients had received a median of 3 prior regimens (17/22 prior
retinoids) and 68% had Stage IV disease. Objective responses were observed in 4
patients (1 CR + 3 PR); stable disease (SD) in 9 patients. Time to response was
median 15.5 days (range 14-113 days) and is a promising finding. In addition
significant pruritus relief was seen in 6 of 11 patients. 
Duration of responses for PTCL CR's was 40-42 weeks and ongoing. Duration of
response in CTCL, CR is 67 weeks and ongoing. 

Fast track designation: Fast track designation was granted by FDA for the
development program for belinostat (PXD101) IV for relapsed or refractory PTCL
after at least one prior systemic therapy. 


The poster presentation will be available on TopoTarget's homepage at
www.topotarget.com 
  
Today's news does not change TopoTarget's full-year financial guidance for 2008.

TopoTarget A/S

	
For further information, please contact:

Peter Buhl Jensen 		
CEO		Mobile	+45 21 60 89 22


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.  In August
2004, CuraGen signed a Clinical Trials Agreement with the NCI under which the
NCI will sponsor several 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.