Positive update of TopoTarget's initial phase II study with belinostat in PTCL and CTCL supports the registration plan in PTCL

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


Copenhagen, Denmark - 16 March 2009 - TopoTarget A/S (OMX: TOPO) has announced
that positive data from a study of belinostat given as monotherapy 1000
mg/m2/daily for 5 days every 3-weeks for the treatment of Peripheral T-Cell
lymphoma (PTCL) and Cutaneous T-Cell lymphoma (CTCL) was presented at an
international Lymphoma meeting in Bologna March 16-18. The data included an
assessment of all treated patients, albeit preliminary since patients are still
on treatment and in follow-up. The study has finalized recruitment with 53
patients treated. Initial data from this study led TopoTarget to initiate its
pivotal study in PTCL in December 2008 following a Special protocol Assessment
(SPA) procedure and Fast Track agreement with the FDA. 

“Importantly these new data support the company's development plan for PTCL. We
have earlier announced that 2 out of 11 patients with PTCL had durable
responses with belinostat. PTCL is a very serious disease in which our medicine
works and the initial data were the basis for our SPA and Fast Track agreement
with the FDA. The now up-dated data show that 5 out of 20 patients have
responded. There is a big unmet medical need in this disease and with response
rates of 25% for PTCL and with complete remissions belinostat monotherapy can
become an important treatment,” says professor Peter Buhl Jensen, CEO of
TopoTarget. 

“Combination therapy is used in order to attack the cancer cell from different
angels and thereby increase response rates. In addition to the benefit obtained
with the drug used as a single agent, belinostat has the big advantage that it
exhibits no dose limiting bone marrow toxicity which is the main cause for dose
reduction in the most successful chemotherapy combinations. This is why we
expect a lot from belinostat in combination therapy as well,” Peter Buhl Jensen
further comments. 

TopoTarget A/S

For further information, please contact:

Peter Buhl Jensen	Telephone	+45 39 17 94 99
CEO		Mobile	+45 21 60 89 22