Senesco Technologies, Inc. (“Senesco” or the “Company”) (OTC QB: SNTI) reported today the completion of cohort 3 of its Phase 1b/2a clinical trial for its drug, SNS01-T, for the treatment of multiple myeloma and lymphoma. The Company has also received approval from its Data Review Committee to proceed to cohort 4, which is expected to require six evaluable patients. The Data Review Committee’s review of the results of cohort 3 concluded that SNS01-T was safe and well tolerated at a dose of 0.2 mg/Kg. No drug-related serious adverse events or dose limiting toxicities have been observed in the study. The patients in cohort 4 will be receiving 0.375 mg/Kg of SNS01-T.
"We are excited to start cohort 4 in our clinical trial at almost twice the dose level of cohort 3. The 0.375 mg/Kg dose is the dose that produced the strongest effect in the pre-clinical cancer models of myeloma and lymphoma,” stated Leslie J. Browne, Ph.D., President and CEO of Senesco. "We are also pleased that in addition to announcing the results of cohort 3 via press release, they will also be presented on Saturday, December 7, 2013 during the evening poster session at the 55th American Society of Hematology Annual Meeting in New Orleans."
The study is an open-label, multiple-dose, dose-escalation study to evaluate the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, mantle cell (MCL) or diffuse large B-cell lymphoma (DLBCL) patients. While the primary objective 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 in multiple myeloma and CT imaging in B-cell lymphomas.
In the study, patients are dosed twice-weekly by intravenous infusion for six weeks followed by an observation period. The first and second groups of patients received respectively 0.0125 mg/Kg and 0.05 mg/Kg per dose. The third group received 0.2 mg/Kg and the planned dose level for group 4 is 0.375 mg/Kg, which is 30 fold higher than the starting dose in group 1.