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 BelCaP Update on positive results for ovarian cancer presented at Biennial Ovarian Cancer Research Symposium in Seattle Copenhagen, Denmark - September 8, 2008 - TopoTarget A/S (OMX: TOPO) announces that an update on positive data from the TopoTarget BelCaP combination (Belinostat+Carboplatin+Taxol) for ovarian cancer was presented at the Biennial Ovarian Cancer Research Symposium in Seattle 4-5 September 2008. ”The positive data presented at this symposium is an improvement of the positive results announced at ASCO in June. The results continue to develop positively and now two more patients, three in total, have obtained completer response (CR),” says Peter Buhl Jensen. ”BelCaP represents a promising approach to a new combination therapy for patients with ovarian cancer with platinum resistant tumours,” comments professor Peter Buhl Jensen, MD, CEO of TopoTarget. The study: Phase II open label, non-randomized multi-center trial of the Histone Deacetylase Inhibitor belinostat, with carboplatin and paclitaxel (BelCaP) in patients with relapsed epithelial ovarian cancer. 35 patients were included with an overall response rate of 43%, four patients continue on therapy. 3 complete remissions (CR) and 12 partial remissions (PR) by RECIST criteria (Response Evaluation Criteria in Solid Tumours) have been reported. Median time to response was 2.5 months and the median duration of response was +5.3 months (range +1.2 to +12.7 months) with 6 responses still ongoing. Conclusion: BelCaP is well-tolerated presenting a safety profile consistent of that observed with chemotherapy alone. Activity has been observed in patients with platinum-sensitive and platinum-resistant tumors, including patients with a platinum-free interval of < 3 months. The substantial anti-tumor activity observed supports further development of BelCaP in patients with recurrent ovarian cancer. The addition of belinostat to platinum-based regimens represents a novel approach to therapy of ovarian cancer. Updated results will be presented. 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 cllinical 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.
BelCaP Update on positive results for ovarian cancer presented at Biennial Ovarian Cancer Research Symposium in Seattle
| Source: Topotarget