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 Positive belinostat data in cutaneous lymphomas presented at EORTCs lymphoma meeting in Copenhagen Copenhagen, Denmark - September 8, 2008 - TopoTarget A/S (OMX: TOPO) announces that positive data from a belinostat phase II study in patients with relapsing or resistant peripheral or cutanous lymphoma (PTCL and CTCL) was presented at the ”CUTANEOUS LYMPHOMAS : FROM THE MOLECULE TO THE CLINIC” in Copenhagen 5-7 September 2008. At the EORTC meeting Dr. Kim (Stanford, USA) and colleagues presented updated results from TopoTarget's phase II study with belinostat for the treatment of cutaneous lymphomas: 2 patients with complete response (CR) and 2 with partial response (PR) of 21 evaluable patients. Response in CTCL was seen relatively fast with a median of 15.5 days, which is clinically relevant. Further more a considerably number of patients with stable disease (SD) was observed. The treatment with intravenously administered belinostat was safe and well tolerated. The objective response rate fulfills the predefined criteria for the continuation of the study into the next phase: the “Simon two-stage” design. The corresponding results in a group of patients with T-Cell lymphoma were as announced earlier this year also positive, two out of 11 evaluable patients with PTCL showed prolonged and continuous complete responses (CR) after treatment with belinostat as monotherapy. It is in the PTCL indication that TopoTarget has just agreed with the FDA the design of its pivotal phase III study. “It is very positive that we now see positive data emerge from the many studies running with belinostat. The CTCL study is one of several where we see belinostat resulting in complete disappearance of the cancer measured by repeated scans,” says professor Peter Buhl Jensen, MD, CEO of TopoTarget. Today's news does not change TopoTarget's full-year financial guidance for 2008. TopoTarget A/S For further information, please contact: Peter Buhl, CEO Telephone +45 39 17 83 92 Mobile +45 21 60 89 22 Background information About TopoTarget TopoTarget (OMX: TOPO) is an international biotech company headquartered in Denmark, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. The company 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). TopoTarget has a broad clinical pipeline with 9 products in development, including belinostat which has shown proof of concept as monotherapy in treating haematological malignancies and positive results in solid tumours where it can be used in combination with full doses of chemotherapy. The company's first marketed product Savene®/Totect® was approved by EMEA in 2006 and the FDA in 2007 and is marketed by TopoTarget's own sales force in Europe and the US. 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.
Positive belinostat data in cutaneous lymphomas presented at EORTCs lymphoma meeting in Copenhagen
| Source: Topotarget