Senesco Technologies has contracted Criterium, Inc. to manage the operational aspects of its Phase Ib/IIa clinical study of SNS01-T, its lead therapeutic candidate for the treatment of multiple myeloma. Criterium is a full-service, global CRO.
The Senesco team recently met with counterparts at Criterium to finalize the operational plans for the conduct and analysis of this open-label, multiple-dose, dose-escalation study, which will evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to relapsed or refractory multiple myeloma patients. The study design calls for twice-weekly dosing of patients for six weeks followed by a four-week safety data review period before escalating to a higher dose level in a new group of patients. While the primary objective of the initial study is to evaluate safety and tolerability, the effect of SNS01-T on tumor response will also be evaluated using multiple well-established criteria including measurement of the monoclonal protein (M-protein). The study is expected to start in 3Q11.
“We are very pleased to have taken another step toward starting the multiple myeloma study and to be working with Criterium on the clinical evaluation of SNS01-T,” stated Leslie J. Browne, Ph.D., Senesco's president and chief executive officer. “We considered multiple CROs that we could have worked with on this study and found that Criterium’s experience and clinical expertise were best aligned with our needs.”
Criterium Selected for Multiple Myeloma Study
By Gil Roth
Published August 8, 2011
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