TopoTarget and CuraGen Announce Initiation of an NCI-sponsored Phase II Clinical Trial of Belinostat for Thymoma and Thymic Carcinoma


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
TopoTarget and CuraGen Announce Initiation of an NCI-sponsored Phase II
Clinical Trial of Belinostat for Thymoma and Thymic Carcinoma 


Copenhagen, Denmark - December 19, 2007 - TopoTarget A/S (OMX: TOPO) and
CuraGen Corporation (Nasdaq: CRGN), announced today the initiation of patient
dosing in a Phase II open-label, multi-center clinical trial evaluating the
efficacy and safety of intravenous belinostat, a small molecule histone
deacetylase (HDAC) inhibitor, for the treatment of patients with previously
treated thymoma and thymic carcinoma.  This trial is being sponsored by the
National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen
for belinostat. 

The Phase II clinical trial is being led by Giuseppe Giaccone, M.D., Ph.D.,
Chief, Medical Oncology Branch/CCR/NCI in Bethesda, MD.  Patients with either
thymoma or thymic carcinoma who have received at least one prior
platinum-containing chemotherapy regimen are eligible for enrollment.  The
trial utilizes a Simon 2-stage design and is expected to enroll up to 33
patients who will receive belinostat administered by intravenous infusion once
daily for five days every three weeks.  Patients will continue to receive
treatment with belinostat until disease progression. 

The primary objective of the study is to determine the objective response rate
by RECIST criteria.  Secondary endpoints include evaluation of the time to
response, duration of response, progression-free and overall survival, and the
safety profile of belinostat.  The pharmacodynamic activity of belinostat will
also be evaluated by assessment of protein expression, changes in p21 and
protein hyperacetylation, and identification of chromosomal gains or losses. 
Patients will be enrolled at multiple sites in the United States. 

“We are very happy for the strong support from the NCI for the belinostat
programme. This study provides an opportunity to help treat patients with
thymoma and thymic carcinoma.”  Said Dr. Peter Buhl Jensen, CEO of TopoTarget.
”Thymoma is an indication where we have previously observed an effect from
belinostat and therefore we look forward to seeing efficacy data from this
study.” 

Today's news does not change TopoTarget's full-year financial guidance for 2007.


TopoTarget A/S

	
For further information, please contact:

Dr. Peter Buhl Jensen	Telephone	+45 39 17 83 41
Chief Executive Officer	Mobile	+45 21 60 89 22

Ulla Hald Buhl 	Telephone	+45 39 17 83 92
Director IR & Communications	Mobile	+45 21 70 10 49




Background information

About Thymoma and Thymic Carcinoma
Thymoma and thymic carcinoma are rare tumors of the thymus with fewer than 1000
patients diagnosed in the US per year. Histologically the tumors are of
epithelial origin and can be classified as well differentiated thymomas,
moderately differentiated atypical thymomas or as poorly differentiated thymic
carcinomas. The tumor is situated in the mediastinum and can be either locally
invasive or metastatic. Primary treatment is surgery, but due to recurrence,
unresectability or metastases there is a need for systemic chemotherapy.
Platinum-based chemotherapy regimens are used as first-line treatment, but more
than 50% of  patients relapse and are in need of second line treatment. There
are currently no drugs approved by the FDA for the treatment of thymoma or
thymic carcinoma. 

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™ was 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

announcement nr  46 07 topotarget announces initiation of nci thymoma study 19 december 2007.pdf