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TopoTarget and CuraGen Initiate Phase II Trial of Belinostat (PXD101) in Combination with Velcade

30 Mar 2007 - TopoTarget A/S and CuraGen Corporation announced the initiation of patient dosing in a Phase II open-label, multi-center clinical trial evaluating the efficacy and safety of intravenous belinostat (PXD101), a small molecule histone deacetylase (HDAC) inhibitor, in combination with Velcade® (bortezomib) for Injection, in multiple myeloma patients refractory to or who have rapidly relapsed from at least one previous bortezomib-containing regimen. Based on preliminary safety results from ongoing Phase Ib trials evaluating belinostat in combination with bortezomib, TopoTarget and CuraGen have initiated this Phase II trial in multiple myeloma patients. The Phase II clinical trial is being led by James Berenson, M.D., Principal Investigator, Medical & Scientific Director at the Institute for Myeloma & Bone Cancer Research, and will be conducted at multiple sites across the U.S. Up to 35 patients are planned for study enrollment with preliminary results anticipated by the end of 2007.
 
"Emerging safety results from our clinical trials that are evaluating belinostat and bortezomib have shown the combination to be generally well-tolerated. Therefore, we have initiated this Phase II study to allow relapsed and/or refractory multiple myeloma patients the ability to receive treatment with belinostat and bortezomib, and anticipate reporting preliminary results from the study by the end of the year," commented Peter Buhl Jensen, Chief Executive Officer of TopoTarget. "As data continues to be generated from our Phase II trials in ovarian cancer, colorectal cancer, and T-cell lymphomas, we look forward to presenting preliminary results during mid-2007, and remain on track to initiate a Phase III program during 2008 and advance belinostat towards registration."
 
As the Phase II study of belinostat and bortezomib begins, CuraGen will close enrollment in their ongoing Phase Ib study of this combination in multiple myeloma. The NCI-sponsored trial evaluating this combination on patients with advanced solid tumors remains open for enrollment.