CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International ... (patients who had available pre- and post...)

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CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International Conference

Date:10/25/2007

patients who had available pre- and post-baseline assessments of tumor. The dose regimen (referred to as BelCaP) of intravenous (IV) belinostat 1000 mg/m2/d in combination with carboplatin AUC = 5 and paclitaxel 175 mg/m2, was well- tolerated.

Reduction in tumor size was seen in 15 of 16 patients by radiologic assessment. To date, objective response has been observed in 8 patients, including 2 partial responses confirmed by RECIST and 6 additional responses that are pending radiologic confirmation. At the time of presentation, 13 additional patients have treatment ongoing with continued radiologic assessment of tumor to determine best response. Activity and responses have been observed in patients with platinum sensitive and platinum resistant disease. CuraGen also announced today that trial has reached the target enrollment.

"We are very encouraged by the level of activity we have seen with BelCaP for the treatment of relapsed ovarian cancer, including activity against platinum resistant tumors," commented Dr. Finkler. "We look forward to continuing to treat those patients currently on study and further defining the efficacy of BelCaP in the treatment of this disease."

"The activity of belinostat in preclinical ovarian studies, either alone or in combination with carboplatin and paclitaxel and in platinum sensitive and platinum resistant cell lines, represents some of the most compelling preclinical data we have developed with belinostat and we are pleased to see it translating into potential clinical benefit for patients with relapsed ovarian cancer," said Dr. Timothy Shannon, President and Chief Executive Officer of CuraGen. "We look forward to collecting the remaining data in this study and working with our advisors to determine a potential registrational path forward for IV belinostat in the treatment of ovarian cancer."

NCI-Sponsored Phase II trial Belinostat in Patients with Refractory or Relapsed Platinum Resistant Epithelial Ovarian
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CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International ...(patients who had available pre- and post...),Health