Belinostat in its first pivotal trial in PTCL


TopoTarget - Company Announcement 

Belinostat in its first pivotal trial in PTCL 
Announcement no. 34-08 / Copenhagen, 17 December 2008

- TopoTarget now initiates recruitment of patients in its pivotal trial of
belinostat in Peripheral T-Cell Lymphoma (PTCL) - 

Copenhagen, Denmark, 17 December 2008 - TopoTarget A/S (OMX: TOPO) announces
the opening of patient recruitment  in the pivotal study intended for
registration of belinostat as monotherapy in the treatment of patients with
Peripheral T-Cell Lymphoma (PTCL), a haematological malignancy associated with
poor prognosis. The trial will enrol approximately 120 patients. TopoTarget has
a Special Protocol Assessment (SPA) agreement with the Food and Drug
Administration (FDA) where the design of the study has been agreed. Furthermore
a Fast Track designation has been granted by the FDA for the development of
belinostat in this indication which supports TopoTarget's rapid market entry
strategy. There is currently no standard therapy approved specifically for
PTCL. 

 “We are proud to be able to announce the initiation of this first pivotal
study for belinostat. PTCL is a disease with a poor prognosis for which there
is no therapy specifically approved.” said Peter Buhl Jensen, Professor, MD,
CEO of TopoTarget. “This is the first step in accordance with our clinical
development plan to bring belinostat to the market as fast as possible. At the
same time we are pursuing the steps necessary to bring belinostat to the market
in larger indications like solid tumors in combination therapy to fully exploit
the clinical and commercial potential of belinostat.” 

TopoTarget A/S

www.topotarget.com

For further information, please contact:

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