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

Thu. December 18, 2008; Posted: 10:49 AM
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Copenhagen, Denmark, Dec 18, 2008 (M2 PRESSWIRE via COMTEX) -- TPTGF | Quote | Chart | News | PowerRating -- 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."

CONTACT: Peter Buhl Jensen, CEO, TopoTarget A/S Tel: +45 39 17 94 99 Tel: +45 21 60 89 22 WWW: http://www.topotarget.com

M2 Communications Ltd disclaims all liability for information provided within M2 PressWIRE. Data supplied by named party/parties. Further information on M2 PressWIRE can be obtained at http://www.presswire.net on the world wide web. Inquiries to info@m2.com.

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