Senesco Technologies has initiated dosing in its phase Ib/IIa clinical study of SNS01-T at the Mayo Clinic in Rochester, MN. The study is an 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 observation period at the end of dosing before escalating to the next higher dose level. While the primary objective of this initial study is to evaluate safety and tolerability, the effect of SNS01-T on time to relapse or progression and tumor response will be assessed using multiple well-established metrics including measurement of the monoclonal protein (M-protein). The first group of three patients will receive 0.0125 mg/kg by intravenous infusion twice-a-week for 6 weeks. The escalated doses administered to the second to fourth groups will be 0.05, 0.2 and 0.375 mg/kg, respectively. A total of approximately 15 patients are expected to be in the study which is planned to last about one year. Senesco intends to open a second clinical site to enhance the rate of patient recruitment.