TopoTarget A/S Symbion Fruebjergvej 3 DK 2100 Copenhagen Ø Denmark Tel: +45 39 17 83 92 Fax: +45 39 17 94 92 CVR-nr: 25695771 www.topotarget.com To the OMX Nordic Exchange Copenhagen, Investor News Investor News No. 07-08 / Copenhagen, September 15, 2008 -TopoTarget to provide update on clinical potential and the latest data on belinostat via conference call on September 17- -Announcement of final data from phase I part of the BelCaP study and update on positive data from the phase II part with BelCaP for ovarian cancer as presented at ESMO in Stockholm- Copenhagen, Denmark - September 15, 2008- TopoTarget A/S (OMX: TOPO) today announced that TopoTarget will host a teleconference on the September 17 to provide an update of clinical possibilities and the latest data with belinostat. Furthermore as promised data from the ovarian phase I/II trial with BelCaP (belinostat+carboplatin+taxol) was presented at the 33rd ESMO (European Society for Medical Oncology) Congress, Stockholm, Sweden 12-16 September 2008. In the phase I part of the study where final data now are presented to the medical doctors activity was observed in heavily pre-treated patients including diagnoses of carcinoma of unknown primary tumour (CUP), ovarian, rectal, pancreatic and bladder cancer. The data presented and announced for the phase II part was identical with the positive data presented at last weeks ovarian cancer meeting in Seattle where the over all response rate was 43%; 3 complete remissions (CR) and 12 partial remissions (PR) were demonstrated in 35 patients. In the phase I part where the data has now been finalized 23 patients were treated to find the recommended dose for phase II, which was belinostat 1000 mg/m2 i.v. once daily days 1-5 in combination with standard doses of carboplatin and paclitaxel administered on day 3 of each treatment cycle. In this group of heavily pretreated patients 2 confirmed partial remissions (PR) were documented in rectal cancer and in pancreatic cancer, respectively. and Activity was observed in patients with primary tumour (CUP), ovarian, rectal, pancreatic and bladder cancer. 11 patients experienced stable disease (SD) ranging from 2 to +28 cycles. In the phase II part (no major changes of data as reported at the Biennial Ovarian Cancer Research Symposium 4-5 September 2008) 35 patients with ovarian cancer all had prior platinum-based therapy (14 and 21 patients had platinum-sensitive and platinum-resistant disease, respectively). In the whole population, overall response rate measured by RECIST (Response Evaluation in Solid Tumours) criteria was 43%. 3 patients had complete remissions (CR) and 12 partial remissions (PR). Median duration of response was +5.3 months (range +1.2-+12.7 months) with 6 responses still ongoing. Median progression-free survival in all 35 patients (11 patients censored for PD) is currently +5.4 months (range +0.1 to +13.9 months) Conclusions from the authors included that BelCaP (belinostat combined with standard doses of carboplatin and paclitaxel) is well-tolerated presenting a safety profile consistent of that observed with chemotherapy alone, and that the substantial anti-tumour activity observed in both platinum-sensitive and platinum-resistant ovarian cancer, including patients with a platinum-free interval of < 3 months, supports further development of BelCaP in patients with recurrent ovarian cancer. Conference call A conference call to provide an update on the clinical development of belinostat will be hosted by Peter Buhl, CEO and Jan Fagerberg Medical Director, Belinostat Project Leader and will be followed by a question and answering session. The conference call takes place on September 17 at 10.00 CET. To participate in the conference call please dial: From Denmark: 70 26 50 40 Outside Denmark: +45 70 26 50 40 or +44 208 817 9301 A replay of the conference call will be available approximately two hours after the conference call and until September 24, 2008 at 5.00 pm (CET) at the following number: +353 1 436 4267 pin code 1397856#. Today's news does not change TopoTarget's full-year financial guidance for 2008. TopoTarget A/S For further information, please contact: Ulla Hald Buhl Telephone +45 39 17 83 92 Director IR & Communications Mobile +45 21 70 10 49 Background information About TopoTarget TopoTarget (OMX: TOPO) is a biotech company, headquartered in Denmark and with subsidiaries in the US, Switzerland, Germany and the UK, dedicated to finding ''Answers for Cancer'' and developing improved cancer therapies. TopoTarget 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) and a strong development foundation has been built. TopoTarget has a broad portfolio of small molecule pre-clinical drug candidates and nine drugs (both small molecules and protein based) are in clinical development, including both novel anti-cancer therapeutics and new cancer indications for existing drugs. Savene®/Totect™ were approved by EMEA in 2006 and the FDA in 2007 and is TopoTarget's first product on the market. 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 provides update on clinical potential and latest data on belinostat via teleconf September 17- and announces BelCaP data from ESMO
| Source: Topotarget