CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International ... (Tumors (EOC) andMicropapillary/Borderlin...)

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

Date:10/25/2007

Tumors (EOC) and Micropapillary/Borderline (LMP) Ovarian Tumors

Data was reported from a Phase II trial evaluating the activity of IV belinostat monotherapy in two ovarian cancer populations that had received up to three prior lines of chemotherapy: patients with Micropapillary/Borderline (LMP) ovarian tumors or patients with refractory or relapsed platinum resistant (progression within 6 months of last platinum treatment) Epithelial Ovarian Tumors (EOC). Primary endpoints of the study were objective response. Secondary endpoints included stable disease rate, survival, tolerability and assessment of molecular changes with therapy. Tumor response was assessed by RECIST and CA-125 criteria every two cycles. This Phase II trial is an open- label study being led by Dr. Amit Oza at Princess Margaret Hospital in Toronto, Canada. The clinical trial is being sponsored by the NCI under a Clinical Trials Agreement with CuraGen for belinostat.

During the poster presentation it was reported that 12 patients with LMP tumors received a median of 4 treatment cycles (range 1 to 13). To date, one LMP patient achieved a partial response (PR), one patient had a CA125 response, nine had SD, and two were not evaluable. Six patients remain on study. Objective responses to belinostat monotherapy were not observed in a heavily pre-treated well-defined platinum-resistant population of patients with EOC. Belinostat was safe and generally well-tolerated in these two ovarian cancer populations.

Dr. Shannon further commented, "We are very encouraged by the level of activity reported with IV belinostat monotherapy against these types of ovarian cancer. We believe that these results support and complement the CuraGen BelCaP activity data in relapsed ovarian cancer."

CLN-9: A Phase I Study of Oral Belinostat (PXD101) in Patients with Advanced Solid Tumors

Initial clinical trial results from the ongoing Phase I study evaluating oral belinostat for the treatment of soli
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CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International ...(Tumors (EOC) andMicropapillary/Borderlin...),Health