Senesco Announces Expansion Of Phase 1b/2a Study To Include Diffuse Large B-Cell Lymphoma And Mantle Cell Lymphoma
Senesco Technologies, Inc. (“Senesco” or the “Company”) (NYSE MKT: SNT) reported today that the clinical trial of SNS01-T has been expanded to include diffuse large B-cell lymphoma (DLBCL) and mantle cell lymphoma (MCL). The first patient with DLBCL was enrolled in cohort 2 and received the first dose last week.
"We are very pleased to have expanded the study to include DLBCL and MCL, which like multiple myeloma, are B-cell cancers that SNS01-T was designed to treat. We submitted a protocol amendment to the FDA in August in order to open the study to patients suffering from these non-Hodgkin’s B-cell lymphomas," stated Leslie J. Browne, Ph.D., President and CEO of Senesco. "The ability to include other hematological cancers broadens our results and may accelerate patient enrollment at the three clinical sites where SNS01-T is being investigated. This should keep us on track to disclose results of cohort 2 around the end of 2012."
Senesco previously reported that two of three patients, who completed dosing with SNS01-T in cohort 1 had not progressed on treatment, based on criteria including the monoclonal protein, and were considered stable at week 3 and week 6, the end of the dosing regimen.
The trial is an open-label, multiple-dose, dose-escalation study, which is evaluating the safety and tolerability of SNS01-T when administered by intravenous infusion to approximately 15 relapsed or refractory multiple myeloma, DLBCL and MCL patients. Patients are dosed twice-weekly for 6 weeks followed by an observation period. The first group of multiple myeloma patients received 0.0125 mg/kg, approximately 1 mg per patient, by intravenous infusion. The second group is now receiving 0.05 mg/kg and the planned dose levels for the third and fourth groups are 0.2 and 0.375 mg/kg, respectively. While the primary objective of this 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.
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