Senesco Technologies, Inc. ("Senesco" or the "Company") (NYSE Amex: SNT) today announced that it has contracted Criterium, Inc. to manage the operational aspects of its Phase Ib/2a clinical study of SNS01-T, the Company's lead therapeutic candidate for the treatment of multiple myeloma.
Criterium, Inc. is a full-service, global clinical research organization (CRO) that offers a unique mix of high-quality clinical research services and communication processes. Criterium's experienced team uses technology-based solutions to manage trials from initial planning to approval.
The Senesco team recently met with their 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 6 weeks followed by a 4-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 the 3rd quarter of 2011.
"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, President and Chief Executive Officer of Senesco Technologies Inc. Dr. Browne continued "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."
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