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 TopoTarget and CuraGen Announce Initiation of an NCI-sponsored Phase II Clinical Trial of Belinostat for Thymoma and Thymic Carcinoma Copenhagen, Denmark - December 19, 2007 - TopoTarget A/S (OMX: TOPO) and CuraGen Corporation (Nasdaq: CRGN), announced today the initiation of patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous belinostat, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of patients with previously treated thymoma and thymic carcinoma. This trial is being sponsored by the National Cancer Institute (NCI) under a Clinical Trials Agreement with CuraGen for belinostat. The Phase II clinical trial is being led by Giuseppe Giaccone, M.D., Ph.D., Chief, Medical Oncology Branch/CCR/NCI in Bethesda, MD. Patients with either thymoma or thymic carcinoma who have received at least one prior platinum-containing chemotherapy regimen are eligible for enrollment. The trial utilizes a Simon 2-stage design and is expected to enroll up to 33 patients who will receive belinostat administered by intravenous infusion once daily for five days every three weeks. Patients will continue to receive treatment with belinostat until disease progression. The primary objective of the study is to determine the objective response rate by RECIST criteria. Secondary endpoints include evaluation of the time to response, duration of response, progression-free and overall survival, and the safety profile of belinostat. The pharmacodynamic activity of belinostat will also be evaluated by assessment of protein expression, changes in p21 and protein hyperacetylation, and identification of chromosomal gains or losses. Patients will be enrolled at multiple sites in the United States. “We are very happy for the strong support from the NCI for the belinostat programme. This study provides an opportunity to help treat patients with thymoma and thymic carcinoma.” Said Dr. Peter Buhl Jensen, CEO of TopoTarget. ”Thymoma is an indication where we have previously observed an effect from belinostat and therefore we look forward to seeing efficacy data from this study.” Today's news does not change TopoTarget's full-year financial guidance for 2007. TopoTarget A/S For further information, please contact: Dr. Peter Buhl Jensen Telephone +45 39 17 83 41 Chief Executive Officer Mobile +45 21 60 89 22 Ulla Hald Buhl Telephone +45 39 17 83 92 Director IR & Communications Mobile +45 21 70 10 49 Background information About Thymoma and Thymic Carcinoma Thymoma and thymic carcinoma are rare tumors of the thymus with fewer than 1000 patients diagnosed in the US per year. Histologically the tumors are of epithelial origin and can be classified as well differentiated thymomas, moderately differentiated atypical thymomas or as poorly differentiated thymic carcinomas. The tumor is situated in the mediastinum and can be either locally invasive or metastatic. Primary treatment is surgery, but due to recurrence, unresectability or metastases there is a need for systemic chemotherapy. Platinum-based chemotherapy regimens are used as first-line treatment, but more than 50% of patients relapse and are in need of second line treatment. There are currently no drugs approved by the FDA for the treatment of thymoma or thymic carcinoma. 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™ was 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 and CuraGen Announce Initiation of an NCI-sponsored Phase II Clinical Trial of Belinostat for Thymoma and Thymic Carcinoma
| Source: Topotarget