CuraGen and TopoTarget Announce Presentation of Belinostat Clinical Trial Results at AACR-NCI-EORTC International ... (and well-tolerated at doses that may pro...)

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

Date:10/25/2007

and well-tolerated at doses that may provide flexibility to complement the intravenous formulation of belinostat which is currently in Phase II development.

NCI-sponsored Phase I trial of Belinostat in Combination with Bortezomib in Patients with Advanced Solid Tumors and Lymphoma

Data on 17 patients, of which 14 were evaluable, were reported from this ongoing dose-escalation trial. The primary objective of the trial was evaluation of the safety profile and determination of the MTD of belinostat in combination with bortezomib for patients with advanced solid tumors or lymphomas, which are refractory to standard therapies or for which no standard treatment exists. Secondary endpoints included pharmacokinetics (PK), biological markers and anti-tumor activity. This Phase I trial is an open- label, dose-escalation study being led by Dr. S. Gail Eckhardt, Director of the Developmental Therapeutics and GI Malignancies Programs and Professor of Medicine at the University of Colorado Health Sciences Center. This trial is being sponsored by the NCI under a CTA with CuraGen for belinostat, and under a Cooperative Research and Development Agreement (CRADA) with Millennium Pharmaceuticals Inc. for bortezomib.

The investigators concluded that intravenous belinostat and bortezomib were well tolerated in combination at doses up to 600 mg/m2 belinostat and 1.3 mg/m2 bortezomib, with ongoing enrollment of patients into this dosing cohort. Activity of the combination reported included one patient with Ewing's Sarcoma that has maintained SD for 4 cycles, and two patients, one with peritoneal and one with appendiceal carcinoma, that have maintained SD for 3 cycles. Adverse events were generally grades 1-2 and reversible. No grade 4 non-hematologic toxicities were reported.

Reprints of the poster presentations will be made available on CuraGen's website at http://www.curagen.com or by emailing

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