Senesco Technologies, Inc. (SNT) reported that the first patient has been enrolled and dosing has been initiated in cohort 2 of its clinical trial with SNS01-T in multiple myeloma.
SNS01-T was well tolerated and met the criteria for Stable Disease in 2 of the 3 evaluable patients that comprised cohort 1.
The study is an open-label, multiple-dose, dose-escalation study, which is assessing the safety and tolerability of SNS01-T when administered by intravenous infusion to around 15 relapsed or refractory multiple myeloma patients.
Patients are dosed twice-weekly for 6 weeks followed by an observation period. The first group of patients received 0.0125 mg/kg, approximately 1 mg per patient, by intravenous infusion. The planned dose levels for the second, third and fourth groups are 0.05, 0.2 and 0.375 mg/kg, respectively.
The company noted that while the primary objective of the study is to evaluate safety and tolerability, the effect of SNS01-T on tumor response and time to relapse or progression will be assessed using multiple well-established metrics including measurement of monoclonal protein.
Leslie Browne, president and CEO of Senesco, said, "Now that cohort 2 is underway and there are three clinical sites recruiting patients we hope to be able to disclose results on the four-fold higher dose of approximately 4 mg per patient around the end of 2012."
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