To NASDAQ OMX Copenhagen A/S
Investor News no. 04-13 / Copenhagen, April 8, 2013
Today Topotarget announced that pharmacokinetic and pharmacodynamic data from a phase I study of belinostat in combination with warfarin are presented on Monday, April 8, 2013 from 1.00 pm EDT at the American Association for Cancer Research (AACR) 2013 Annual Meeting in Washington.
The phase I study (CLN-20) of histone deacetylase inhibitor belinostat in combination with warfarin in patients with solid tumors or hematological malignancies, with a total of 18 patients, has been conducted to investigate a potential drug-drug interaction between belinostat and drugs metabolized by the enzyme CYP2C9. The CLN-20 study is a supportive study for the NDA (New Drug Application) filing for belinostat in peripheral T-cell lymphoma (PTCL).
Belinostat administration had no significant effect on pharmacokinetic parameters of S-warfarin. No statistically significant drug interaction was observed between S-warfarin and belinostat and no clinically significant impact was identified through the assessment of the blood clotting by INR (international normalized ratio) and aPTT (activated partial thromboplastin times) values.
Belinostat was well-tolerated when administered at 1000mg/m2 in patients with various advanced malignancies who had failed multiple other treatments. Belinostat demonstrated anti-tumor activity and reached plasma levels that resulted in a partial response and stable disease in three patients with advanced cancer.
Background
The poster is based on a full abstract announced by Topotarget on March 7, 2013.
Topotarget A/S
For further information, please contact:
Anders Vadsholt, CEO: Direct: +45 39 17 83 45
Background information
About Topotarget
Topotarget (NASDAQ OMX: TOPO) is an international biopharmaceutical company headquartered in Copenhagen, Denmark, dedicated to clinical development and registration of oncology products. In collaboration with Spectrum Pharmaceuticals, Inc., Topotarget focuses on the development of its lead drug candidate, belinostat, which has shown positive results in the treatment of hematological malignancies and solid tumors, obtained by both mono- and combination therapy. For more information, please refer to www.topotarget.com.
Topotarget Safe Harbor Statement
This announcement may contain forward-looking statements, including statements about Topotarget A/S’ expectations to the progression of Topotarget A/S’ clinical pipeline and with respect to cash burn guidance. Such statements are subject to risks and uncertainties of which many are outside the control of Topotarget A/S, and which could cause actual results to differ materially from those described. Topotarget A/S disclaims 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 Danish law.
