TopoTarget A/S Symbion Fruebjergvej 3 DK 2100 Cpenhagen Denmark Tel: +45 39 17 83 92 Fax: +45 39 17 94 92 CVR-nr: 25695771 www.topotarget.com TopoTarget Present New Clinical Results with belinostat at the 33rd ESMO Congress and the 7th Biennial Ovarian Cancer Research Symposium Copenhagen, 9 July 2008 - TopoTarget A/S (CSE: TOPO) announced that preliminary clinical data on belinostat, a histone deacetylase (HDAC) inhibitor being investigated for the treatment of cancer, will be presented at two upcoming medical meetings: The 7th Biennial Ovarian Cancer Research Symposium which is being hosted in Seattle, Washington, September 4-5, 2008 and the 33rd ESMO congress, which is being hosted in Stockholm, Sweden, September 12-16, 2008. 7th Biennial Ovarian Cancer Research Symposium - An oral presentation entitled, “Updated results from a phase II multicenter trial of the histone deacetylase inhibitor (HDACi) belinostat, carboplatin and paclitaxel (BelCaP) in patients (pts) with relapsed epithelial ovarian cancer (EOC)”, will be made during the symposium entitled “Novel Therapeutics and Clinical Trials” on Friday, September 5, 2008 from 10.45 - 11.45 a.m. 33rd ESMO Congress - A poster discussion entitled, “Phase (Ph) I/II study of the histone deacetylase inhibitor belinostat (Bel) in combination with carboplatin (Ca) and paclitaxel (P) in advanced solid tumors (Ph I) and relapsed ovarian cancer (Ph II)” will be made during the session entitled “Developmental Therapeutics” on Sunday, September 14, 2008 from 12.30 - 13.30 p.m. in auditorium K11. TopoTarget A/S For further information, please contact: Ulla Hald Buhl Director IR & Communications Mobile +45 21 70 10 49 Background information About Belinostat Belinostat is a promising small molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single-agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, cis-retinoic acid, azacitidine and Velcade® (bortezomib) for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to arrest growth of cancer cells (including drug resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents. Intravenous belinostat is currently being evaluated in multiple clinical trials as a potential treatment for cutaneous and peripheral T-cell lymphomas, B-cell lymphomas, AML, mesothelioma, soft tissue sarcoma, MDS, and liver, colorectal, and ovarian cancers, either alone or in combination with anti- cancer therapies. An oral formulation of belinostat is also being evaluated in a Phase I clinical trial for patients with advanced solid tumors. Several trials in the belinostat program are conducted under a Clinical Trail Agreement (CTA) under which the NCI sponsors clinical trials to investigate belinostat for the treatment of various cancers, both as a single-agent and in combination chemotherapy regimens. In May 2005, TopoTarget announced the signing of a Cooperative Research and Development Agreement (CRADA) with the NCI to conduct preclinical and nonclinical studies on belinostat in order to better understand its anti-tumor activity and to provide supporting information for clinical trials. 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.
TopoTarget Present New Clinical Results with belinostat at the 33rd ESMO Congress and the 7th Biennial Ovarian Cancer Research Symposium
| Source: Topotarget